Self-adherent Absorbent Silver Dressing in Adults After Hip or Knee Arthroplasty

• Sponsor: Molnlycke Health Care AB (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03016078
• Collaborator: (none)
• Enrollment: 21
• Location: 1
• Arm: 1
• Actual Duration (Months): 2.1
• Patients Per Site Per Month: 9.8

Study Details

Study Description

Brief Summary

The overall rationale for this investigation is to evaluate the clinical performance potential for Mepilex Border Post-Op Ag in the ability to minimize the risk of skin related post-operative wound complications such as blistering, maceration and redness at the incision and surrounding skin.

Condition or Disease	Intervention/Treatment	Phase
Arthroplasties, Hip Replacement; Arthroplasties, Knee Replacement	Device: Mepilex Border Post-Op Ag	N/A

Detailed Description

This was a descriptive, open, prospective, non-controlled clinical investigation conducted on 21 enrolled subjects at one site in the United states of America (USA).

The target subjects were male or female, 18 years and older, undergoing elective primary hip or knee arthroplasty with a possibility to participate in a follow-up visit 7 days after surgery. The primary purpose was to investigate if there was any skin damage under the dressing from operation day to last visit. Performance of the dressing as well as comfort, conformability, acceptability and pain at dressing removal was also followed-up until post-op day 7.

Study Design

• Study Type: Interventional
• Actual Enrollment: 21 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Single Center, Open, Non-controlled Investigation to Evaluate the Performance of a Flexible, Self-adherent Absorbent Silver Dressing Coated With a Soft Silicone Layer After Elective Primary Total Hip or Knee Arthroplasty
• Actual Study Start Date: Feb 1, 2017
• Actual Primary Completion Date: Apr 1, 2017
• Actual Study Completion Date: Apr 7, 2017

Arms and Interventions

Arm	Intervention/Treatment
Other: Mepilex Border Post-Op Ag Dressing A soft silicone foam dressing that absorbs wound exudate maintains a moist wound healing environment and has antimicrobial properties	Device: Mepilex Border Post-Op Ag; To investigate if there was any skin damage under the dressing from operation day to last visit.

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Damage to the Incision and Surrounding Skin [Daily visits, up to 7 days]

   The primary outcome is damage to the incision and surrounding skin from operation day to last visit in terms of: Blistering (Yes/No) by visit Redness under dressing (Yes/No) by visit Redness outside dressing (Yes/No) by visit Maceration under dressing (Yes/No) by visit Maceration outside dressing (Yes/No) by visit

Secondary Outcome Measures

1. Number of Participants With Leakage of the Dressing [Daily visits, up to 7 days]

   Nurse/ Investigator evaluate: Leakage (No/Yes)

2. Number of Participants With Dressing Sticking to the Staples/Sutures [Daily visits, up to 7 days]

   Nurse/ Investigator evaluate: Dressing sticks to the staples/sutures (No/Yes)

3. Number of Participants With Bleeding Caused by Dressing Removal [Daily visits, up to 7 days]

   Nurse/ Investigator evaluate: Bleeding caused by dressing removal (No/Yes)

4. Participants' Dressing Wear Time (Days) [7 days]

   The number of days the dressing can stay on are evaluated

5. Number of Dressing Changes Per Subject [Daily visits, up to 7 days]

   To evaluate the number of dressing changes per subject

6. Evaluation of the Dressing Capacity of Handling Blood [Daily visits, up to 7 days]

   Nurse or Investigator evaluate: Poor, Good, Very Good,Very Good, Excellent on a Likert scale.

7. Residuals of the Dressing Material in the Wound or Surrounding Skin at Any Visit (for Patients With at Least One Dressing Change) [Daily visits, up to 7 days]

   Residuals of the dressing material in the wound or surrounding skin at any visit (for patients with at least one dressing change). Nurse/ Investigator evaluate with No/Yes

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Age ≥ 18 years

2. Available for a follow-up visit including dressing change 7 days after surgery

3. Plan for elective primary hip or knee arthroplasty

4. Plan for incision size ≤18 cm

5. Provision of informed consent i.e. subject must be able to understand and sign the Patient Information and Consent Form

6. Undergoing elective primary arthroplasty of the hip or knee.

Exclusion Criteria

1. Known allergy/hypersensitivity to any of the components of the dressing

2. Multi-trauma

3. Undergoing arthroplasty due to tumor

4. Previous incision at the same knee or same side of the hip

5. Wound at the surgical site prior to surgery

6. Neurological deficit of operated side (hemiplegia, etc.)

7. Documented skin disease at time of enrollment, as judged by the investigator

8. Previously enrolled in the present investigation

9. Inclusion in other ongoing investigations at present that would preclude the subject from participating in this investigation as judged by the investigator

10. Involvement in the planning and conduct of the clinical investigation (applies to all MHC staff, investigational site staff and third party vendor)

11. Dressing size does not fit the incision area (>18 cm)

12. Complications that would increase wound risks if investigational dressing is applied

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The CORE Institute Gilbert	Gilbert	Arizona	United States	85297

Sponsors and Collaborators

• Molnlycke Health Care AB

Investigators

• Principal Investigator: Steven Myerthall, Dr, Center for Orthopedic Research and Education, The CORE Institute

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Nov 15, 2016

More Information

Publications

None provided.

• Responsible Party: Molnlycke Health Care AB
• ClinicalTrials.gov Identifier: NCT03016078
• Other Study ID Numbers: MxB Po Ag 01
• First Posted: Jan 10, 2017
• Last Update Posted: Feb 14, 2018
• Last Verified: Feb 1, 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No

Study Results

Participant Flow

Recruitment Details	Investigation period: Feb 2017 - March 2017. The study was conducted on 21 enrolled subjects at one site in the US. Subjects included were 18 years, and above, undergoing elective primary hip or knee arthroplasty.

Arm/Group Title	Mepilex Border Post-Op Ag Dressing
Arm/Group Description	A soft silicone foam dressing that absorbs wound exudate maintains a moist wound healing environment and has antimicrobial properties
Period Title: Overall Study
STARTED	21
COMPLETED	19
NOT COMPLETED	2

Baseline Characteristics

Arm/Group Title	Mepilex Border Post-Op Ag Dressing
Arm/Group Description	A soft silicone foam dressing that absorbs wound exudate maintains a moist wound healing environment and has antimicrobial properties
Overall Participants	21
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	68.4 (5.8)
Sex: Female, Male (Count of Participants)
Female	10 47.6%
Male	11 52.4%
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (Count of Participants)
United States	21 100%
Blistering (Number of blisters) [Number]
Number [Number of blisters]	0

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Damage to the Incision and Surrounding Skin
Description	The primary outcome is damage to the incision and surrounding skin from operation day to last visit in terms of: Blistering (Yes/No) by visit Redness under dressing (Yes/No) by visit Redness outside dressing (Yes/No) by visit Maceration under dressing (Yes/No) by visit Maceration outside dressing (Yes/No) by visit
Time Frame	Daily visits, up to 7 days

Outcome Measure Data

Analysis Population Description

The ITT population included all subjects who underwent at least one post-enrolment treatment. The number of participants analyzed varies due to that no data was captured at some visits, since the dressing was not changed at all visits.

Arm/Group Title	The Study Group
Arm/Group Description	Only one arm. The target subjects were male or female, 18 years and older, undergoing elective primary hip or knee arthroplasty.
Measure Participants	21
Blistering visit 3	0 0%
Blistering visit 5	0 0%
Blistering visit 6	0 0%
Redness Under Dressing visit 3	0 0%
Redness Under Dressing visit 5	0 0%
Redness Under Dressing visit 6	5 23.8%
Redness Outside Dressing visit 3	0 0%
Redness Outside Dressing visit 5	0 0%
Redness Outside Dressing visit 6	2 9.5%
Maceration Under Dressing visit 3	0 0%
Maceration Under Dressing visit 5	0 0%
Maceration Under Dressing visit 6	0 0%
Maceration Outside Dressing visit 3	0 0%
Maceration Outside Dressing visit 5	0 0%
Maceration Outside Dressing visit 6	0 0%

2. Secondary Outcome

Title	Number of Participants With Leakage of the Dressing
Description	Nurse/ Investigator evaluate: Leakage (No/Yes)
Time Frame	Daily visits, up to 7 days

Outcome Measure Data

Analysis Population Description

The ITT population included all subjects who underwent at least one post-enrolment treatment. The number of participants analyzed varies due to that no data was captured at some visits, since the dressing was not changed at all visits.

Arm/Group Title	The Study Group
Arm/Group Description	Only one arm. The target subjects were male or female, 18 years and older, undergoing elective primary hip or knee arthroplasty.
Measure Participants	21
Leakage visit 2	0 0%
Leakage visit 3	0 0%
Leakage visit 5	0 0%
Leakage visit 6	0 0%

3. Secondary Outcome

Title	Number of Participants With Dressing Sticking to the Staples/Sutures
Description	Nurse/ Investigator evaluate: Dressing sticks to the staples/sutures (No/Yes)
Time Frame	Daily visits, up to 7 days

Outcome Measure Data

Analysis Population Description

The ITT population included all subjects who underwent at least one post-enrolment treatment. The number of participants analyzed varies due to that no data was captured at some visits, since the dressing was not changed at all visits.

Arm/Group Title	The Study Group
Arm/Group Description	Only one arm. The target subjects were male or female, 18 years and older, undergoing elective primary hip or knee arthroplasty.
Measure Participants	21
Dressing sticks to the staples visit 3	0 0%
Dressing sticks to the staples visit 5	0 0%
Dressing sticks to the staples visit 6	0 0%

4. Secondary Outcome

Title	Number of Participants With Bleeding Caused by Dressing Removal
Description	Nurse/ Investigator evaluate: Bleeding caused by dressing removal (No/Yes)
Time Frame	Daily visits, up to 7 days

Outcome Measure Data

Analysis Population Description

The ITT population included all subjects who underwent at least one post-enrolment treatment. The number of participants analyzed varies due to that no data was captured at some visits, since the dressing was not changed at all visits..

Arm/Group Title	The Study Group
Arm/Group Description	Only one arm. The target subjects were male or female, 18 years and older, undergoing elective primary hip or knee arthroplasty.
Measure Participants	21
Bleeding caused by the dressing removal visit 3	0 0%
Bleeding caused by the dressing removal visit 5	0 0%
Bleeding caused by the dressing removal visit 6	0 0%

5. Secondary Outcome

Title	Participants' Dressing Wear Time (Days)
Description	The number of days the dressing can stay on are evaluated
Time Frame	7 days

Outcome Measure Data

Analysis Population Description

The ITT population included all subjects who underwent at least one post-enrolment treatment. The number of participants analyzed varies due to that no data was captured at some visits, since the dressing was not changed at all visits.

Arm/Group Title	The Study Group
Arm/Group Description	Only one arm. The target subjects were male or female, 18 years and older, undergoing elective primary hip or knee arthroplasty.
Measure Participants	21
Mean (Standard Deviation) [days]	6.35 (1.57)

6. Secondary Outcome

Title	Number of Dressing Changes Per Subject
Description	To evaluate the number of dressing changes per subject
Time Frame	Daily visits, up to 7 days

Outcome Measure Data

Analysis Population Description

The ITT population included all subjects who underwent at least one post-enrolment treatment. The number of participants analyzed varies due to that no data was captured at some visits, since the dressing was not changed at all visits.

Arm/Group Title	The Study Group
Arm/Group Description	Only one arm. The target subjects were male or female, 18 years and older, undergoing elective primary hip or knee arthroplasty.
Measure Participants	21
Mean (Standard Deviation) [Number of dressing changes per subject]	1.00 (0.00)

7. Secondary Outcome

Title	Evaluation of the Dressing Capacity of Handling Blood
Description	Nurse or Investigator evaluate: Poor, Good, Very Good,Very Good, Excellent on a Likert scale.
Time Frame	Daily visits, up to 7 days

Outcome Measure Data

Analysis Population Description

The ITT population included all subjects who underwent at least one post-enrolment treatment. The number of participants analyzed varies due to that no data was captured at some visits, since the dressing was not changed at all visits.

Arm/Group Title	The Study Group
Arm/Group Description	Only one arm. The target subjects were male or female, 18 years and older, undergoing elective primary hip or knee arthroplasty.
Measure Participants	21
Poor visit 3	0 0%
Poor visit 5	0 0%
Poor visit 6	0 0%
Good visit 3	0 0%
Good visit 5	0 0%
Good visit 6	0 0%
Very good visit 3	0 0%
Very good visit 5	0 0%
Very good visit 6	0 0%
Excellent visit 3	0 0%
Excellent visit 5	3 14.3%
Excellent visit 6	19 90.5%
Not applicable visit 6	1 4.8%

8. Secondary Outcome

Title	Residuals of the Dressing Material in the Wound or Surrounding Skin at Any Visit (for Patients With at Least One Dressing Change)
Description	Residuals of the dressing material in the wound or surrounding skin at any visit (for patients with at least one dressing change). Nurse/ Investigator evaluate with No/Yes
Time Frame	Daily visits, up to 7 days

Outcome Measure Data

Analysis Population Description

The ITT population included all subjects who underwent at least one post-enrolment treatment. The number of participants analyzed varies due to that no data was captured at some visits, since the dressing was not changed at all visits.

Arm/Group Title	The Study Group
Arm/Group Description	Only one arm. The target subjects were male or female, 18 years and older, undergoing elective primary hip or knee arthroplasty.
Measure Participants	21
Count of Participants [Participants]	3 14.3%

Adverse Events

Time Frame	Average of one Week
Arm/Group Title	The Study Group
Arm/Group Description	Only one arm. The target subjects were male or female, 18 years and older, undergoing elective primary hip or knee arthroplasty.
All Cause Mortality
	The Study Group
	Affected / at Risk (%)	# Events
Total	0/21 (0%)
Serious Adverse Events
	The Study Group
	Affected / at Risk (%)	# Events
Total	0/21 (0%)
Other (Not Including Serious) Adverse Events
	The Study Group
	Affected / at Risk (%)	# Events
Total	1/21 (4.8%)
Skin and subcutaneous tissue disorders
Redness at border of derssing	1/21 (4.8%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.