A Clinical Study to Compare MAR-CUTIS With Dermabond Advanced
Study Details
Study Description
Brief Summary
This was a randomized, open-label, multicenter, comparator-controlled clinical study to compare MAR-CUTIS with Dermabond Advanced in closure of surgical incisions and lacerations less than or equal to (<=)15 centimeter (cm). Eligible participants were randomized 2:1 to MAR-CUTIS or Dermabond Advanced.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Dermabond Advanced Dermabond Advanced (a topical skin adhesive) was applied on Day 0. Dermabond Advanced was applied in 1 continuous layer onto a dry wound through painting motions; the wound was held for 60 seconds to allow for complete polymerization. |
Device: Dermabond Advanced
Dermabond Advanced was applied in 1 continuous layer onto a dry wound through painting motions, taking care not to apply adhesive between the wound edges.
|
| Experimental: MAR-CUTIS MAR-CUTIS (polyurethane-based skin adhesive) was applied on Day 0. MAR-CUTIS was applied in 1 to 2 millimeter (mm) thick layer ensuring that at least 1 cm of the glue is applied over the length of the wound on each side; the wound was held for approximately 30 seconds to allow for initial polymerization. |
Device: MAR-CUTIS
MAR-CUTIS was applied in 1 to 2 mm thick layer, ensuring that at least 1 cm of the glue was applied over the length of the wound on each side. The amount of the glue applied was calculated such that one 5-mL syringe covers approximately 8 cm of wound length (giving a total of 10 cm per syringe). For wounds >8 cm, 2 syringes were required.
|
Outcome Measures
Primary Outcome Measures
- Number of Participants With Total Dehiscence of Target Wound at Day 10 [At Day 10]
Wound dehiscence involved the breaking open of the surgical incision along the suture. Number of participants with dehiscence (reported as "yes") and number of participants showing no dehiscence (reported as "No").
- Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) [From Baseline (Day 0) up to Month 3]
A TEAE was defined as any adverse event (AE) that occured during the on-treatment-period (i.e. after the start of the application of the Investigational Medical Device (IMD) (Day 0) until the end-of-treatment visit [Month 3]).This included any events related to the procedures, the IMD, or the comparator. An SAE was any untoward medical occurrence or effect that: led to death, or led to serious deterioration in the health of the participant, that either resulted in: life-threatening illness or injury, or a permanent impairment of a body structure or a body function, or in-patient or prolonged hospitalization, or medical or surgical intervention to prevent life-threatening illness or injury or permanent, or impairment to a body structure or a body function. Or, led to fetal distress, fetal death, or a congenital abnormality or birth defect.
Secondary Outcome Measures
- Number of Participants With Total Dehiscence of Target Wound at Month 1 [At Month 1]
Wound dehiscence involved the breaking open of the surgical incision along the suture.
- Number of Participant's Reporting Satisfaction With the Device Using Patient and Observer Scar Assessment Scale (POSAS) [At Month 1 and Month 3]
The POSAS was a questionnaire that was developed to assess scar quality. It consisted of 2 separate 6-item scales (Patient Scale and Observer Scale), both of which were scored on a 10-point rating scale. In addition, each scale has an overall "opinion" with 1 being no pain, no itching, or normal skin and 10 being worst scar imaginable with pain and itching, where lower scores indicated better outcome.
- Percentage of Participants With Wound Infections [At Day 10, and Month 1]
The wound infection incidence was assessed at the scheduled visits diagnosed according to the Centers for Disease Control and Prevention (CDC) criteria for surgical site infection. Wound infection was assessed and the following symptoms were evaluated if infection was present: Presence of erythema Presence of edema Presence of pain at rest Presence of elevated temperature Percentage of participants with wound infections around target wound are reported.
- Investigator's Satisfaction With the Device Using Patient and Observer Scar Assessment Scale (POSAS) [At Month 1 and Month 3]
The POSAS was a questionnaire that was developed to assess scar quality. Investigator were asked to rate the severity of participant's scar compared to normal skin. The overall "opinion" ranged from 1= no pain, no itching, or normal skin to 10 = worst scar imaginable with pain and itching, where lower scores indicated better outcome.
- Investigator's Satisfaction With the Device Using Modified Hollander Cosmesis Scale [At Day 10 and Month 1]
The investigator's satisfaction with the cosmetic outcome was assessed using the Modified Hollander Cosmesis Scale (mHCS). The mHCS consisted of 6 wound characteristics: Step-off borders, Contour irregularities, Target wound margin separation, Edge inversion, Excessive inflammation, Overall appearance. It was evaluated as "poor" or "good". Each of the characteristics was graded on a 0 (no/good) or 1 (yes/poor) point scale, where lower score indicated better outcome. Number of participants with different wound characteristics (poor and good) and participants with missing response are also reported.
- Number of Participant Reporting Satisfaction With the Device Using a Product-Related Questionnaire [At Day 10 and Month 1]
The questionnaire consisted of 5 yes/no questions that evaluated the participant's experience with the adhesive, 1 question that rated the effect of the closed wound on several daily activities (i.e., showering, getting dressed), 1 question that evaluated satisfaction with the wound closure, and visual analog scales which rate pain and scarring.
- Number of Participants Reporting Satisfaction With the Device Evaluated by Investigator Using a Product-Related Questionnaire [At Day 0 and Month 1]
The questionnaire consisted of 5 yes/no questions that assess the investigator's experience applying the adhesive (i.e., easy to use, fast, without complications), a visual analog scale that rates usability of the product from 1 (poor = very difficult to use) to 100 (excellent = very easy to use), and 1 question that evaluates satisfaction with the adhesive.
- Investigator's Satisfaction With Ease of Use With the Device Using a Product-Related Questionnaire [At Month 1]
The questionnaire consisted of 8 yes/no questions and 1 opinion question that evaluated the investigator's experience with use of the adhesive (i.e., instructions easy to understand, preparation of the syringe being easy and fast, glue hardening time).
Eligibility Criteria
Criteria
Inclusion Criteria:
For participants with surgical incisions:
- Participants underwent closure of surgical incision 6 to 15 centimeters (cms) following laparotomy, abdominal hysterectomy, or laparoscopic intervention.
For participants with lacerations:
- Participants requiring closure of a laceration on face (avoiding the immediate area around the eye) or extremities. In participants with multiple lacerations, one was selected as the target wound (i.e., greatest length and meets the study entry criteria).
For all participants:
-
Participant had given written informed consent/assent to participate.
-
Male and female participants at least 2 years of age and body weight 10 kilogram (kg) or greater.
-
Participants willing and capable of following instructions for wound care provided by the investigator and agreeing to return for all treatment control visits specified in this clinical study.
Exclusion Criteria:
For participants with lacerations:
-
Wounds on mucosal surfaces or across mucocutaneous junctions (e.g., oral cavity, lips, eyes).
-
Wounds which might be regularly exposed to body fluids or with dense natural hair (e.g., scalp); wounds on ears.
-
Wounds on palms and feet.
-
Animal or human bites.
-
Lacerations that were heavily contaminated.
-
Punctured or crushed wounds.
-
Participants with lacerations having wound treatment more than 6 hours after the trauma.
For all participants:
-
Participants requiring suturing with sutures greater than 5 mm thickness.
-
Participants with documented skin disease or skin conditions (e.g., excessive hair at the site of surgery, scar tissue, wound, tattoo, coloration, or pre-existing open sores at the site of surgery that would interfere with the application of Investigational Medical Device or the skin assessment, as judged by the investigator).
-
Participant with any factors that might had an adverse effect on wound healing (e.g., previous history of keloid formation or hypertrophy [as well in the family]), history of immunosuppression, chronic systemic infection, or poor general health.
-
Participants with known blood clotting disorders.
-
Participants receiving steroids, immunosuppressants, chemotherapy, or anticoagulants.
-
Participants having known or suspected allergy or sensitivity to polyurethane, cyanoacrylates, formaldehyde, tapes or adhesives, or benzalkonium chloride.
-
Participant participating in any current clinical study with a non-CE ("Conformitee Europeene") marked device or investigational product.
-
Participant who was pregnant or breastfeeding.
-
Participant with history of a significant dermatologic disease or condition, such as atopic dermatitis, psoriasis, lichen ruber planus, vitiligo or conditions known to alter the skin appearance or physiologic response (e.g., decompensated diabetes mellitus, porphyria) that involves the investigative site.
Removal of Participants From Therapy or Assessments:
Only participants that were withdrawn from the study due to product failure at the time of application were replaced.
Participants might stop the study for any of the following reasons:
-
Participant request.
-
Use of non-permitted concurrent therapy.
-
Lost to follow-up (considered lost to follow-up only before Day 10).
-
Occurrence of adverse events not compatible with the continuation of participant participation in the study, in the investigator's opinion, or unacceptable to the participant to continue.
-
Investigator request.
-
Inter-current illness.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | 004 - CHU Amiens-Picardie | Amiens | France | 80054 | |
| 2 | 005 - Hôpital Privé Paul d'Egine | Champigny-sur-Marne | France | 94500 | |
| 3 | 010 - Charité Berlin | Berlin | Germany | 13353 | |
| 4 | 006 - Universitätsklinikum Heidelberg | Heidelberg | Germany | 69120 | |
| 5 | 009 - Klinikum Magdeburg | Magdeburg | Germany | 39130 | |
| 6 | 001 - Hospital Universitari Vall d'Hebron | Barcelona | Spain | 08035 | |
| 7 | 022 - Hospital General Universitario Gregorio Maranon | Madrid | Spain | 28007 | |
| 8 | 003 - University Hospital Virgen del Rocío | Seville | Spain | 41013 | |
| 9 | 019 - Barnsley Hospital | Barnsley | United Kingdom | S75 2EP | |
| 10 | 017 - Birmingham Children's Hospital | Birmingham | United Kingdom | B4 6NH | |
| 11 | 018 - Bristol Royal Hospital for Children | Bristol | United Kingdom | BS2 8AE | |
| 12 | 021 - University Hospital of Wales | Cardiff | United Kingdom | CF14 4XW | |
| 13 | 013 - The Princess Alexandra Hospital | Harlow | United Kingdom | CM20 1QX | |
| 14 | 011 - Leeds Teaching Hospitals | Leeds | United Kingdom | LS9 7TF | |
| 15 | 016 - St George's Hospital | London | United Kingdom | SW17 0QT | |
| 16 | 014 - Queen Elizabeth the Queen Mother Hospital | Margate | United Kingdom | CT9 4AN | |
| 17 | 020 - Royal Gwent Hospital | Newport | United Kingdom | NP20 2UB | |
| 18 | 012 - Peterborough City Hospital | Peterborough | United Kingdom | PE3 9GZ | |
| 19 | 015 - Musgrove Park Hospital | Taunton | United Kingdom | TA1 5DA |
Sponsors and Collaborators
- Grünenthal GmbH
- Syneos Health
Investigators
- Study Director: Study Director, Grünenthal GmbH
Study Documents (Full-Text)
More Information
Publications
None provided.- KF7021-04
- 1012937
Study Results
Participant Flow
| Recruitment Details | The study was conducted at 16 sites in 4 countries from 30 October 2018 to 04 September 2019. A total of 107 participants were enrolled of which 18 participants were screen failures. Screen failures were mainly due to inclusion criteria not met. |
|---|---|
| Pre-assignment Detail | A Total of 89 participants were randomized and treated in the study. Assignment to arms was done in 2:1 ratio (MAR-CUTIS:Dermabond Advanced). Randomization was stratified by wound type (lacerations and incisions), skin type and age groups. |
| Arm/Group Title | Dermabond Advanced | MAR-CUTIS |
|---|---|---|
| Arm/Group Description | Dermabond Advanced (a topical skin adhesive) was applied on Day 0. Dermabond Advanced was applied in 1 continuous layer onto a dry wound through painting motions; the wound was held for 60 seconds to allow for complete polymerization. | MAR-CUTIS (polyurethane-based skin adhesive) was applied on Day 0. MAR-CUTIS was applied in 1 to 2 millimeter (mm) thick layer ensuring that at least 1 cm of the glue is applied over the length of the wound on each side; the wound was held for approximately 30 seconds to allow for initial polymerization. |
| Period Title: Overall Study | ||
| STARTED | 29 | 60 |
| COMPLETED | 15 | 29 |
| NOT COMPLETED | 14 | 31 |
Baseline Characteristics
| Arm/Group Title | Dermabond Advanced | MAR-CUTIS | Total |
|---|---|---|---|
| Arm/Group Description | Dermabond Advanced (a topical skin adhesive) was applied on Day 0. Dermabond Advanced was applied in 1 continuous layer onto a dry wound through painting motions; the wound was held for 60 seconds to allow for complete polymerization. | MAR-CUTIS (polyurethane-based skin adhesive) was applied on Day 0. MAR-CUTIS was applied in 1 to 2 mm thick layer ensuring that at least 1 cm of the glue is applied over the length of the wound on each side; the wound was held for approximately 30 seconds to allow for initial polymerization. | Total of all reporting groups |
| Overall Participants | 29 | 60 | 89 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
45.0
(26.7)
|
49.9
(24.9)
|
48.3
(25.5)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
9
31%
|
25
41.7%
|
34
38.2%
|
| Male |
20
69%
|
35
58.3%
|
55
61.8%
|
| Race (NIH/OMB) (Count of Participants) | |||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
| Asian |
1
3.4%
|
1
1.7%
|
2
2.2%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
0
0%
|
4
6.7%
|
4
4.5%
|
| White |
27
93.1%
|
55
91.7%
|
82
92.1%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
1
3.4%
|
0
0%
|
1
1.1%
|
Outcome Measures
| Title | Number of Participants With Total Dehiscence of Target Wound at Day 10 |
|---|---|
| Description | Wound dehiscence involved the breaking open of the surgical incision along the suture. Number of participants with dehiscence (reported as "yes") and number of participants showing no dehiscence (reported as "No"). |
| Time Frame | At Day 10 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was performed on Full analysis set (FAS) that included all participants randomized that were allocated to one of the 2 treatment groups and had at least 1 post-treatment assessment. |
| Arm/Group Title | Dermabond Advanced | MAR-CUTIS |
|---|---|---|
| Arm/Group Description | Dermabond Advanced (a topical skin adhesive) was applied on Day 0. Dermabond Advanced was applied in 1 continuous layer onto a dry wound through painting motions; the wound was held for 60 seconds to allow for complete polymerization. | MAR-CUTIS (polyurethane-based skin adhesive) was applied on Day 0. MAR-CUTIS was applied in 1 to 2 mm thick layer ensuring that at least 1 cm of the glue is applied over the length of the wound on each side; the wound was held for approximately 30 seconds to allow for initial polymerization. |
| Measure Participants | 28 | 59 |
| No Dehiscence |
27
93.1%
|
46
76.7%
|
| Dehiscence |
1
3.4%
|
13
21.7%
|
| Title | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) |
|---|---|
| Description | A TEAE was defined as any adverse event (AE) that occured during the on-treatment-period (i.e. after the start of the application of the Investigational Medical Device (IMD) (Day 0) until the end-of-treatment visit [Month 3]).This included any events related to the procedures, the IMD, or the comparator. An SAE was any untoward medical occurrence or effect that: led to death, or led to serious deterioration in the health of the participant, that either resulted in: life-threatening illness or injury, or a permanent impairment of a body structure or a body function, or in-patient or prolonged hospitalization, or medical or surgical intervention to prevent life-threatening illness or injury or permanent, or impairment to a body structure or a body function. Or, led to fetal distress, fetal death, or a congenital abnormality or birth defect. |
| Time Frame | From Baseline (Day 0) up to Month 3 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was performed on safety analysis set that included all participants where the application of MAR-CUTIS or Dermabond Advanced had started. Participants were analyzed under the actual treatment received. |
| Arm/Group Title | Dermabond Advanced | MAR-CUTIS |
|---|---|---|
| Arm/Group Description | Dermabond Advanced (a topical skin adhesive) was applied on Day 0. Dermabond Advanced was applied in 1 continuous layer onto a dry wound through painting motions; the wound was held for 60 seconds to allow for complete polymerization. | MAR-CUTIS (polyurethane-based skin adhesive) was applied on Day 0. MAR-CUTIS was applied in 1 to 2 mm thick layer ensuring that at least 1 cm of the glue is applied over the length of the wound on each side; the wound was held for approximately 30 seconds to allow for initial polymerization. |
| Measure Participants | 29 | 60 |
| Any TEAE |
13
44.8%
|
36
60%
|
| Any serious TEAE |
4
13.8%
|
13
21.7%
|
| Any TEAE leading to withdrawal from trial |
0
0%
|
2
3.3%
|
| Title | Number of Participants With Total Dehiscence of Target Wound at Month 1 |
|---|---|
| Description | Wound dehiscence involved the breaking open of the surgical incision along the suture. |
| Time Frame | At Month 1 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Study was terminated early and data was not collected for this assessment. |
| Arm/Group Title | Dermabond Advanced | MAR-CUTIS |
|---|---|---|
| Arm/Group Description | Dermabond Advanced (a topical skin adhesive) was applied on Day 0. Dermabond Advanced was applied in 1 continuous layer onto a dry wound through painting motions; the wound was held for 60 seconds to allow for complete polymerization. | MAR-CUTIS (polyurethane-based skin adhesive) was applied on Day 0. MAR-CUTIS was applied in 1 to 2 mm thick layer ensuring that at least 1 cm of the glue is applied over the length of the wound on each side; the wound was held for approximately 30 seconds to allow for initial polymerization. |
| Measure Participants | 0 | 0 |
| Title | Number of Participant's Reporting Satisfaction With the Device Using Patient and Observer Scar Assessment Scale (POSAS) |
|---|---|
| Description | The POSAS was a questionnaire that was developed to assess scar quality. It consisted of 2 separate 6-item scales (Patient Scale and Observer Scale), both of which were scored on a 10-point rating scale. In addition, each scale has an overall "opinion" with 1 being no pain, no itching, or normal skin and 10 being worst scar imaginable with pain and itching, where lower scores indicated better outcome. |
| Time Frame | At Month 1 and Month 3 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Study was terminated early and data was not collected for this assessment. |
| Arm/Group Title | Dermabond Advanced | MAR-CUTIS |
|---|---|---|
| Arm/Group Description | Dermabond Advanced (a topical skin adhesive) was applied on Day 0. Dermabond Advanced was applied in 1 continuous layer onto a dry wound through painting motions; the wound was held for 60 seconds to allow for complete polymerization. | MAR-CUTIS (polyurethane-based skin adhesive) was applied on Day 0. MAR-CUTIS was applied in 1 to 2 mm thick layer ensuring that at least 1 cm of the glue is applied over the length of the wound on each side; the wound was held for approximately 30 seconds to allow for initial polymerization. |
| Measure Participants | 0 | 0 |
| Title | Percentage of Participants With Wound Infections |
|---|---|
| Description | The wound infection incidence was assessed at the scheduled visits diagnosed according to the Centers for Disease Control and Prevention (CDC) criteria for surgical site infection. Wound infection was assessed and the following symptoms were evaluated if infection was present: Presence of erythema Presence of edema Presence of pain at rest Presence of elevated temperature Percentage of participants with wound infections around target wound are reported. |
| Time Frame | At Day 10, and Month 1 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was performed on FAS. |
| Arm/Group Title | Dermabond Advanced | MAR-CUTIS |
|---|---|---|
| Arm/Group Description | Dermabond Advanced (a topical skin adhesive) was applied on Day 0. Dermabond Advanced was applied in 1 continuous layer onto a dry wound through painting motions; the wound was held for 60 seconds to allow for complete polymerization. | MAR-CUTIS (polyurethane-based skin adhesive) was applied on Day 0. MAR-CUTIS was applied in 1 to 2 mm thick layer ensuring that at least 1 cm of the glue is applied over the length of the wound on each side; the wound was held for approximately 30 seconds to allow for initial polymerization. |
| Measure Participants | 28 | 59 |
| Day 10 |
0
0%
|
3.4
5.7%
|
| Month 1 |
0
0%
|
3.4
5.7%
|
| Title | Investigator's Satisfaction With the Device Using Patient and Observer Scar Assessment Scale (POSAS) |
|---|---|
| Description | The POSAS was a questionnaire that was developed to assess scar quality. Investigator were asked to rate the severity of participant's scar compared to normal skin. The overall "opinion" ranged from 1= no pain, no itching, or normal skin to 10 = worst scar imaginable with pain and itching, where lower scores indicated better outcome. |
| Time Frame | At Month 1 and Month 3 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Study was terminated early and data was not collected for this assessment. |
| Arm/Group Title | Dermabond Advanced | MAR-CUTIS |
|---|---|---|
| Arm/Group Description | Dermabond Advanced (a topical skin adhesive) was applied on Day 0. Dermabond Advanced was applied in 1 continuous layer onto a dry wound through painting motions; the wound was held for 60 seconds to allow for complete polymerization. | MAR-CUTIS (polyurethane-based skin adhesive) was applied on Day 0. MAR-CUTIS was applied in 1 to 2 mm thick layer ensuring that at least 1 cm of the glue is applied over the length of the wound on each side; the wound was held for approximately 30 seconds to allow for initial polymerization. |
| Measure Participants | 0 | 0 |
| Title | Investigator's Satisfaction With the Device Using Modified Hollander Cosmesis Scale |
|---|---|
| Description | The investigator's satisfaction with the cosmetic outcome was assessed using the Modified Hollander Cosmesis Scale (mHCS). The mHCS consisted of 6 wound characteristics: Step-off borders, Contour irregularities, Target wound margin separation, Edge inversion, Excessive inflammation, Overall appearance. It was evaluated as "poor" or "good". Each of the characteristics was graded on a 0 (no/good) or 1 (yes/poor) point scale, where lower score indicated better outcome. Number of participants with different wound characteristics (poor and good) and participants with missing response are also reported. |
| Time Frame | At Day 10 and Month 1 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was performed on FAS. |
| Arm/Group Title | Dermabond Advanced | MAR-CUTIS |
|---|---|---|
| Arm/Group Description | Dermabond Advanced (a topical skin adhesive) was applied on Day 0. Dermabond Advanced was applied in 1 continuous layer onto a dry wound through painting motions; the wound was held for 60 seconds to allow for complete polymerization. | MAR-CUTIS (polyurethane-based skin adhesive) was applied on Day 0. MAR-CUTIS was applied in 1 to 2 mm thick layer ensuring that at least 1 cm of the glue is applied over the length of the wound on each side; the wound was held for approximately 30 seconds to allow for initial polymerization. |
| Measure Participants | 28 | 59 |
| Day 10: Step-off borders: poor |
2
6.9%
|
8
13.3%
|
| Day 10: Step-off borders: good |
22
75.9%
|
47
78.3%
|
| Day 10: Step-off borders: missing |
4
13.8%
|
4
6.7%
|
| Day 10: Contour irregularities: poor |
2
6.9%
|
9
15%
|
| Day 10: Contour irregularities: good |
22
75.9%
|
46
76.7%
|
| Day 10: Contour irregularities: missing |
4
13.8%
|
4
6.7%
|
| Day 10: Wound margin separation: poor |
1
3.4%
|
11
18.3%
|
| Day 10: Wound margin separation: good |
23
79.3%
|
44
73.3%
|
| Day 10: Wound margin separation: missing |
4
13.8%
|
4
6.7%
|
| Day 10: Edge inversion: poor |
1
3.4%
|
5
8.3%
|
| Day 10: Edge inversion: good |
23
79.3%
|
50
83.3%
|
| Day 10: Edge inversion: missing |
4
13.8%
|
4
6.7%
|
| Day 10: Excessive inflammation: poor |
3
10.3%
|
1
1.7%
|
| Day 10: Excessive inflammation: good |
21
72.4%
|
54
90%
|
| Day 10: Excessive inflammation: missing |
4
13.8%
|
4
6.7%
|
| Day 10: Overall appearance: poor |
1
3.4%
|
6
10%
|
| Day 10: Overall appearance: good |
23
79.3%
|
49
81.7%
|
| Day 10: Overall appearance: Missing |
4
13.8%
|
4
6.7%
|
| Month 1: Step-off borders: poor |
0
0%
|
3
5%
|
| Month 1: Step-off borders: good |
25
86.2%
|
50
83.3%
|
| Month 1: Step-off borders: missing |
3
10.3%
|
5
8.3%
|
| Month 1: Contour irregularities: poor |
2
6.9%
|
1
1.7%
|
| Month 1: Contour irregularities: good |
23
79.3%
|
52
86.7%
|
| Month 1: Contour irregularities: missing |
3
10.3%
|
5
8.3%
|
| Month 1: Wound margin separation: poor |
1
3.4%
|
5
8.3%
|
| Month 1: Wound margin separation: good |
24
82.8%
|
48
80%
|
| Month 1: Wound margin separation: missing |
3
10.3%
|
5
8.3%
|
| Month 1: Edge inversion: poor |
1
3.4%
|
1
1.7%
|
| Month 1: Edge inversion: good |
24
82.8%
|
52
86.7%
|
| Month 1: Edge inversion: missing |
3
10.3%
|
5
8.3%
|
| Month 1: Excessive inflammation: poor |
1
3.4%
|
2
3.3%
|
| Month 1: Excessive inflammation: good |
24
82.8%
|
51
85%
|
| Month 1: Excessive inflammation: missing |
3
10.3%
|
5
8.3%
|
| Month 1: Overall appearance: poor |
0
0%
|
3
5%
|
| Month 1: Overall appearance: good |
25
86.2%
|
50
83.3%
|
| Month 1: Overall appearance: missing |
3
10.3%
|
5
8.3%
|
| Title | Number of Participant Reporting Satisfaction With the Device Using a Product-Related Questionnaire |
|---|---|
| Description | The questionnaire consisted of 5 yes/no questions that evaluated the participant's experience with the adhesive, 1 question that rated the effect of the closed wound on several daily activities (i.e., showering, getting dressed), 1 question that evaluated satisfaction with the wound closure, and visual analog scales which rate pain and scarring. |
| Time Frame | At Day 10 and Month 1 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Study was terminated early and data was not collected for this assessment. |
| Arm/Group Title | Dermabond Advanced | MAR-CUTIS |
|---|---|---|
| Arm/Group Description | Dermabond Advanced (a topical skin adhesive) was applied on Day 0. Dermabond Advanced was applied in 1 continuous layer onto a dry wound through painting motions; the wound was held for 60 seconds to allow for complete polymerization. | MAR-CUTIS (polyurethane-based skin adhesive) was applied on Day 0. MAR-CUTIS was applied in 1 to 2 mm thick layer ensuring that at least 1 cm of the glue is applied over the length of the wound on each side; the wound was held for approximately 30 seconds to allow for initial polymerization. |
| Measure Participants | 0 | 0 |
| Title | Number of Participants Reporting Satisfaction With the Device Evaluated by Investigator Using a Product-Related Questionnaire |
|---|---|
| Description | The questionnaire consisted of 5 yes/no questions that assess the investigator's experience applying the adhesive (i.e., easy to use, fast, without complications), a visual analog scale that rates usability of the product from 1 (poor = very difficult to use) to 100 (excellent = very easy to use), and 1 question that evaluates satisfaction with the adhesive. |
| Time Frame | At Day 0 and Month 1 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Study was terminated early and data was not collected for this assessment. |
| Arm/Group Title | Dermabond Advanced | MAR-CUTIS |
|---|---|---|
| Arm/Group Description | Dermabond Advanced (a topical skin adhesive) was applied on Day 0. Dermabond Advanced was applied in 1 continuous layer onto a dry wound through painting motions; the wound was held for 60 seconds to allow for complete polymerization. | MAR-CUTIS (polyurethane-based skin adhesive) was applied on Day 0. MAR-CUTIS was applied in 1 to 2 mm thick layer ensuring that at least 1 cm of the glue is applied over the length of the wound on each side; the wound was held for approximately 30 seconds to allow for initial polymerization. |
| Measure Participants | 0 | 0 |
| Title | Investigator's Satisfaction With Ease of Use With the Device Using a Product-Related Questionnaire |
|---|---|
| Description | The questionnaire consisted of 8 yes/no questions and 1 opinion question that evaluated the investigator's experience with use of the adhesive (i.e., instructions easy to understand, preparation of the syringe being easy and fast, glue hardening time). |
| Time Frame | At Month 1 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Study was terminated early and data was not collected for this assessment. |
| Arm/Group Title | Dermabond Advanced | MAR-CUTIS |
|---|---|---|
| Arm/Group Description | Dermabond Advanced (a topical skin adhesive) was applied on Day 0. Dermabond Advanced was applied in 1 continuous layer onto a dry wound through painting motions; the wound was held for 60 seconds to allow for complete polymerization. | MAR-CUTIS (polyurethane-based skin adhesive) was applied on Day 0. MAR-CUTIS was applied in 1 to 2 mm thick layer ensuring that at least 1 cm of the glue is applied over the length of the wound on each side; the wound was held for approximately 30 seconds to allow for initial polymerization. |
| Measure Participants | 0 | 0 |
Adverse Events
| Time Frame | AE data was collected from Baseline until the end-of-treatment visit (Month 3). | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | Reported AEs and deaths are TEAEs that was defined as any adverse event that occurred during the on-treatment-period (i.e. after the start of the application of the IMD (Baseline [Day 0]) until the end-of-treatment visit (Month 3). Analysis was performed on safety analysis set. | |||
| Arm/Group Title | Dermabond Advanced | MAR-CUTIS | ||
| Arm/Group Description | Dermabond Advanced (a topical skin adhesive) was applied on Day 0. Dermabond Advanced was applied in 1 continuous layer onto a dry wound through painting motions; the wound was held for 60 seconds to allow for complete polymerization. | MAR-CUTIS (polyurethane-based skin adhesive) was applied on Day 0. MAR-CUTIS was applied in 1 to 2 mm thick layer ensuring that at least 1 cm of the glue is applied over the length of the wound on each side; the wound was held for approximately 30 seconds to allow for initial polymerization. | ||
All Cause Mortality |
||||
| Dermabond Advanced | MAR-CUTIS | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/29 (0%) | 1/60 (1.7%) | ||
Serious Adverse Events |
||||
| Dermabond Advanced | MAR-CUTIS | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 4/29 (13.8%) | 13/60 (21.7%) | ||
| Cardiac disorders | ||||
| Myocardial infarction | 0/29 (0%) | 0 | 1/60 (1.7%) | 1 |
| Gastrointestinal disorders | ||||
| Ileus | 0/29 (0%) | 0 | 1/60 (1.7%) | 1 |
| Ileus paralytic | 1/29 (3.4%) | 1 | 1/60 (1.7%) | 1 |
| Intestinal obstruction | 0/29 (0%) | 0 | 1/60 (1.7%) | 1 |
| Rectal haemorrhage | 0/29 (0%) | 0 | 1/60 (1.7%) | 1 |
| Infections and infestations | ||||
| Abdominal abscess | 1/29 (3.4%) | 1 | 0/60 (0%) | 0 |
| Catheter site infection | 0/29 (0%) | 0 | 1/60 (1.7%) | 1 |
| Diverticulitis | 0/29 (0%) | 0 | 1/60 (1.7%) | 1 |
| Intestinal sepsis | 0/29 (0%) | 0 | 1/60 (1.7%) | 1 |
| Pelvic abscess | 0/29 (0%) | 0 | 1/60 (1.7%) | 1 |
| Postoperative wound infection | 0/29 (0%) | 0 | 1/60 (1.7%) | 1 |
| Stoma site infection | 1/29 (3.4%) | 1 | 0/60 (0%) | 0 |
| Urosepsis | 1/29 (3.4%) | 1 | 0/60 (0%) | 0 |
| Injury, poisoning and procedural complications | ||||
| Abdominal wound dehiscence | 1/29 (3.4%) | 1 | 0/60 (0%) | 0 |
| Anastomotic leak | 2/29 (6.9%) | 2 | 1/60 (1.7%) | 1 |
| Gastrointestinal anastomotic leak | 0/29 (0%) | 0 | 1/60 (1.7%) | 1 |
| Urinary retention postoperative | 0/29 (0%) | 0 | 1/60 (1.7%) | 1 |
| Wound dehiscence | 0/29 (0%) | 0 | 2/60 (3.3%) | 2 |
| Metabolism and nutrition disorders | ||||
| Hyponatraemia | 0/29 (0%) | 0 | 1/60 (1.7%) | 1 |
| Nervous system disorders | ||||
| Dizziness | 0/29 (0%) | 0 | 1/60 (1.7%) | 1 |
| Renal and urinary disorders | ||||
| Urinary retention | 0/29 (0%) | 0 | 1/60 (1.7%) | 1 |
Other (Not Including Serious) Adverse Events |
||||
| Dermabond Advanced | MAR-CUTIS | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 12/29 (41.4%) | 31/60 (51.7%) | ||
| Blood and lymphatic system disorders | ||||
| Anaemia | 0/29 (0%) | 0 | 3/60 (5%) | 3 |
| Leukocytosis | 1/29 (3.4%) | 1 | 0/60 (0%) | 0 |
| Cardiac disorders | ||||
| Atrial fibrillation | 1/29 (3.4%) | 1 | 0/60 (0%) | 0 |
| Bradycardia | 1/29 (3.4%) | 1 | 0/60 (0%) | 0 |
| Sinus tachycardia | 0/29 (0%) | 0 | 1/60 (1.7%) | 1 |
| Tachycardia | 2/29 (6.9%) | 2 | 2/60 (3.3%) | 2 |
| Eye disorders | ||||
| Ocular hyperaemia | 1/29 (3.4%) | 1 | 0/60 (0%) | 0 |
| Gastrointestinal disorders | ||||
| Abdominal discomfort | 1/29 (3.4%) | 1 | 0/60 (0%) | 0 |
| Abdominal distension | 1/29 (3.4%) | 2 | 1/60 (1.7%) | 2 |
| Abdominal pain | 4/29 (13.8%) | 4 | 6/60 (10%) | 8 |
| Abdominal pain lower | 0/29 (0%) | 0 | 1/60 (1.7%) | 1 |
| Abdominal tenderness | 0/29 (0%) | 0 | 1/60 (1.7%) | 1 |
| Constipation | 2/29 (6.9%) | 2 | 2/60 (3.3%) | 2 |
| Diarrhoea | 1/29 (3.4%) | 1 | 6/60 (10%) | 7 |
| Dysphagia | 1/29 (3.4%) | 1 | 0/60 (0%) | 0 |
| Faecal vomiting | 1/29 (3.4%) | 1 | 0/60 (0%) | 0 |
| Gastrointestinal sounds abnormal | 1/29 (3.4%) | 1 | 0/60 (0%) | 0 |
| Gastrooesophageal reflux disease | 0/29 (0%) | 0 | 1/60 (1.7%) | 1 |
| Haematemesis | 1/29 (3.4%) | 2 | 0/60 (0%) | 0 |
| Haematochezia | 1/29 (3.4%) | 1 | 0/60 (0%) | 0 |
| Ileus | 0/29 (0%) | 0 | 2/60 (3.3%) | 2 |
| Nausea | 3/29 (10.3%) | 4 | 6/60 (10%) | 7 |
| Rectal haemorrhage | 0/29 (0%) | 0 | 1/60 (1.7%) | 1 |
| Vomiting | 1/29 (3.4%) | 1 | 6/60 (10%) | 7 |
| General disorders | ||||
| Dehiscence | 0/29 (0%) | 0 | 1/60 (1.7%) | 1 |
| Fatigue | 0/29 (0%) | 0 | 1/60 (1.7%) | 1 |
| Oedema peripheral | 0/29 (0%) | 0 | 1/60 (1.7%) | 1 |
| Peripheral swelling | 1/29 (3.4%) | 1 | 0/60 (0%) | 0 |
| Pyrexia | 1/29 (3.4%) | 1 | 6/60 (10%) | 6 |
| Swelling | 0/29 (0%) | 0 | 1/60 (1.7%) | 1 |
| Infections and infestations | ||||
| Abdominal sepsis | 1/29 (3.4%) | 1 | 0/60 (0%) | 0 |
| Bacterial infection | 0/29 (0%) | 0 | 1/60 (1.7%) | 1 |
| Lower respiratory tract infection | 1/29 (3.4%) | 1 | 0/60 (0%) | 0 |
| Upper respiratory tract infection | 1/29 (3.4%) | 1 | 0/60 (0%) | 0 |
| Urinary tract infection | 1/29 (3.4%) | 1 | 1/60 (1.7%) | 1 |
| Wound infection | 0/29 (0%) | 0 | 3/60 (5%) | 3 |
| Wound infection bacterial | 1/29 (3.4%) | 1 | 0/60 (0%) | 0 |
| Injury, poisoning and procedural complications | ||||
| Drain site complication | 1/29 (3.4%) | 1 | 0/60 (0%) | 0 |
| Post procedural complication | 0/29 (0%) | 0 | 1/60 (1.7%) | 1 |
| Postoperative wound complication | 0/29 (0%) | 0 | 1/60 (1.7%) | 1 |
| Procedural pain | 0/29 (0%) | 0 | 2/60 (3.3%) | 2 |
| Skin abrasion | 0/29 (0%) | 0 | 1/60 (1.7%) | 1 |
| Stomal hernia | 0/29 (0%) | 0 | 1/60 (1.7%) | 1 |
| Wound | 2/29 (6.9%) | 2 | 1/60 (1.7%) | 1 |
| Wound complication | 1/29 (3.4%) | 1 | 1/60 (1.7%) | 1 |
| Wound dehiscence | 1/29 (3.4%) | 2 | 4/60 (6.7%) | 4 |
| Wound haemorrhage | 0/29 (0%) | 0 | 1/60 (1.7%) | 2 |
| Wound necrosis | 1/29 (3.4%) | 1 | 0/60 (0%) | 0 |
| Investigations | ||||
| Blood potassium decreased | 0/29 (0%) | 0 | 1/60 (1.7%) | 1 |
| Cortisol decreased | 1/29 (3.4%) | 1 | 0/60 (0%) | 0 |
| Haemoglobin decreased | 0/29 (0%) | 0 | 1/60 (1.7%) | 1 |
| Heart rate irregular | 1/29 (3.4%) | 1 | 0/60 (0%) | 0 |
| Metabolism and nutrition disorders | ||||
| Decreased appetite | 0/29 (0%) | 0 | 3/60 (5%) | 3 |
| Folate deficiency | 0/29 (0%) | 0 | 1/60 (1.7%) | 1 |
| Hyperglycaemia | 0/29 (0%) | 0 | 1/60 (1.7%) | 2 |
| Hypokalaemia | 1/29 (3.4%) | 1 | 1/60 (1.7%) | 1 |
| Hypomagnesaemia | 0/29 (0%) | 0 | 1/60 (1.7%) | 1 |
| Hyponatraemia | 0/29 (0%) | 0 | 1/60 (1.7%) | 1 |
| Musculoskeletal and connective tissue disorders | ||||
| Back pain | 0/29 (0%) | 0 | 1/60 (1.7%) | 1 |
| Joint swelling | 1/29 (3.4%) | 1 | 0/60 (0%) | 0 |
| Mobility decreased | 0/29 (0%) | 0 | 1/60 (1.7%) | 1 |
| Muscle tightness | 1/29 (3.4%) | 1 | 0/60 (0%) | 0 |
| Musculoskeletal pain | 0/29 (0%) | 0 | 1/60 (1.7%) | 1 |
| Nervous system disorders | ||||
| Dizziness | 0/29 (0%) | 0 | 1/60 (1.7%) | 1 |
| Headache | 2/29 (6.9%) | 2 | 1/60 (1.7%) | 1 |
| Hypoaesthesia | 1/29 (3.4%) | 1 | 2/60 (3.3%) | 2 |
| Migraine | 1/29 (3.4%) | 1 | 0/60 (0%) | 0 |
| Neuralgia | 0/29 (0%) | 0 | 1/60 (1.7%) | 1 |
| Paraesthesia | 0/29 (0%) | 0 | 1/60 (1.7%) | 2 |
| Somnolence | 1/29 (3.4%) | 1 | 0/60 (0%) | 0 |
| Psychiatric disorders | ||||
| Anxiety | 0/29 (0%) | 0 | 1/60 (1.7%) | 1 |
| Confusional state | 0/29 (0%) | 0 | 1/60 (1.7%) | 1 |
| Delirium | 1/29 (3.4%) | 1 | 0/60 (0%) | 0 |
| Renal and urinary disorders | ||||
| Haematuria | 0/29 (0%) | 0 | 1/60 (1.7%) | 1 |
| Urinary retention | 1/29 (3.4%) | 1 | 1/60 (1.7%) | 1 |
| Reproductive system and breast disorders | ||||
| Genital swelling | 0/29 (0%) | 0 | 1/60 (1.7%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||||
| Cough | 1/29 (3.4%) | 1 | 1/60 (1.7%) | 1 |
| Tachypnoea | 1/29 (3.4%) | 1 | 0/60 (0%) | 0 |
| Skin and subcutaneous tissue disorders | ||||
| Blister | 1/29 (3.4%) | 1 | 0/60 (0%) | 0 |
| Decubitus ulcer | 0/29 (0%) | 0 | 1/60 (1.7%) | 2 |
| Dermatitis | 1/29 (3.4%) | 1 | 0/60 (0%) | 0 |
| Dermatitis contact | 0/29 (0%) | 0 | 1/60 (1.7%) | 1 |
| Itching scar | 0/29 (0%) | 0 | 1/60 (1.7%) | 1 |
| Night sweats | 1/29 (3.4%) | 1 | 0/60 (0%) | 0 |
| Pruritus | 0/29 (0%) | 0 | 1/60 (1.7%) | 1 |
| Skin lesion | 0/29 (0%) | 0 | 1/60 (1.7%) | 1 |
| Vascular disorders | ||||
| Haemorrhage | 1/29 (3.4%) | 1 | 0/60 (0%) | 0 |
| Hypertension | 0/29 (0%) | 0 | 1/60 (1.7%) | 1 |
| Hypotension | 2/29 (6.9%) | 2 | 1/60 (1.7%) | 1 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The sponsor reserves the right to review any proposed presentation of the results of this trial before they are submitted for publication or public disclosure. Neither party (e.g., the sponsor, the coordinating investigator) has the right to prohibit publication or public disclosure unless it can be shown to affect possible patent rights.
Results Point of Contact
| Name/Title | Grünenthal Clinical-Trials Helpdesk |
|---|---|
| Organization | Grünenthal GmbH |
| Phone | +49 241 569 ext 3223 |
| clinical-trials@grunenthal.com |
- KF7021-04
- 1012937