Clinical Investigation of Two Different Wound Dressings

• Sponsor: Molnlycke Health Care AB (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT02904200
• Collaborator: (none)
• Enrollment: 2
• Locations: 2
• Arms: 2
• Actual Duration (Months): 7
• Patient Per Site: 1
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

The primary objective of this investigation is to evaluate changes on Peri-Wound skin from baseline to termination when using two different wound dressings

The secondary objectives are to evaluate pain before, during, and after dressing removal from baseline to termination

Condition or Disease	Intervention/Treatment	Phase
Wounds and Injuries	Device: Silicon adhesive dressing; Device: Acrylic adhesive dressing	N/A

Detailed Description

A prospective randomized clinical investigation will be conducted at two sites in Sweden.

Male or female, 18 years or older with following wound types:

• traumatic, surgical or dehisced wounds,

• venous leg ulcer or pressure ulcer will be included into the clinical investigation.

32 evaluated subjects (i:e 16 subjects per arm) will be followed during maximum three weeks. The treatment arm (either silicon adhesive dressing or acrylic adhesive dressing). Patients will be randomized using optimal allocation (minimization) balancing for the following baseline variables type of skin (normal/dry/flaky/oily/moist) and age. Eligible patients will be randomized to receive either silicon adhesive dressing or acrylic adhesive dressing in a ratio of 1:1 provided.

Study Design

• Study Type: Interventional
• Actual Enrollment: 2 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Randomized Open, Controlled Pilot Investigation Comparing Trauma to the Periwound Skin and Pain During Treatment With Avance NPWT System When Using Two Different Fixations
• Actual Study Start Date: Oct 1, 2016
• Actual Primary Completion Date: May 1, 2017
• Actual Study Completion Date: May 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Silicon adhesive dressing Sterile soft silicon adhesive dressing	Device: Silicon adhesive dressing; Sterile soft silicon adhesive dressing
Active Comparator: Acrylic adhesive dressing Sterile acrylic adhesive dressing	Device: Acrylic adhesive dressing; Sterile acrylic adhesive dressing

Outcome Measures

Primary Outcome Measures

1. Changes on Peri-Wound Skin [Visit 4 last visit (day 12)]

   The primary objective of this investigation is to evaluate changes on Peri-Wound skin from baseline to termination when using two different wound dressings. The primary endpoint could not be calculated as intended because the baseline score was not evaluable due to missing values for the one subject that completed follow up. The primary outcome is therefore presented at 12 days. The total of the five scores provide a range from 0 to 15, with higher scores indicating a worse outcome. The primary endpoint was assessed through the change in the sum of Peri-Wound Skin outcome scores (0-15) collected at each visit (Visit 1 (baseline), Visit 2 (day 4), Visit 3 (day 7), Visit 4 last visit (day 12)) from baseline to termination. The sum of scores will be obtained from five separate data scores, Redness/Irritation, Flaky, Maceration, Blistering, Skin tears, which will be scored separately with a value between 0 and 3 (None=0, Mild=1, Moderate=2, Severe=3).

Secondary Outcome Measures

1. VAS Scale (0-100mm) [0-12 days. Visit 1 (baseline), Visit 2 (day 4), Visit 3 (day 7), Visit 4 last visit (day 12)]

   Pain level before, during and after dressing removal. A visual analog scale (VAS) was used by the subjects to assess pain, with a range from 0 to 100, where 100 indicates the worst possible pain.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

1. Traumatic, surgical or dehisced wounds, Venous Leg Ulcer, Diabetic Foot Ulcer or Pressure Ulcer indicated for treatment with NPWT therapy

2. In case of multiple wounds the target wound must be ≥10 cm distant from other wounds. Selection of the target wound is according to the investigator's preference.

3. Peri-wound skin assessable and 5 cm of peri-wound skin present around the wound

4. Male or female, 18 years of age and above

5. Signed Informed Consent

Exclusion Criteria:

1. Dressing sizes does not fit the target wound

2. Unexplored blind tunnels or non-enteric fistula

3. Untreated osteomyelitis

4. Malignant wounds

5. Subjects treated with systemic immunosuppressive or glucocorticosteroids, except subjects taking occasional doses or doses less than 10mg prednisolon/day or equivalent.

6. Wounds with necrotic tissue or eschar (if not adequately debrided)

7. Significantly bleeding wounds, as judged by the investigator

8. Subject not suitable for the investigation according to the investigator's judgment

9. Subject included in other ongoing clinical investigation which could interfere with this investigation, as judged by the investigator

10. Known allergy/hypersensitivity to any of the components included into the investigation.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sundsvalls sjukhus	Sundsvall		Sweden
2	Norrlands Universitetssjukhus	Umea		Sweden

Sponsors and Collaborators

• Molnlycke Health Care AB

Investigators

• Principal Investigator: Marianne Bergstrom, Sundsvalls Sjukhus

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Sep 11, 2015

More Information

Publications

None provided.

• Responsible Party: Molnlycke Health Care AB
• ClinicalTrials.gov Identifier: NCT02904200
• Other Study ID Numbers: Avance 02
• First Posted: Sep 16, 2016
• Last Update Posted: Apr 1, 2021
• Last Verified: Sep 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Wounds and Injuries; Silicon

Study Results

Participant Flow

Arm/Group Title	Avance® Film With Safetac®	Avance® Transparent Film
Arm/Group Description	Sterile soft silicon adhesive dressing Silicon adhesive dressing: Sterile soft silicon adhesive dressing	Sterile acrylic adhesive dressing Acrylic adhesive dressing: Sterile acrylic adhesive dressing
Period Title: Overall Study
STARTED	2	0
COMPLETED	1	0
NOT COMPLETED	1	0

Baseline Characteristics

Arm/Group Title	Avance® Film With Safetac®
Arm/Group Description	Sterile soft silicon adhesive dressing Silicon adhesive dressing: Sterile soft silicon adhesive dressing
Overall Participants	2
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	2 100%
>=65 years	0 0%
Sex: Female, Male (Count of Participants)
Female	1 50%
Male	1 50%
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (participants) [Number]
Sweden	2 100%
Baseline Pain (score on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [score on a scale]	1.5 (1.5)

Outcome Measures

1. Primary Outcome

Title	Changes on Peri-Wound Skin
Description	The primary objective of this investigation is to evaluate changes on Peri-Wound skin from baseline to termination when using two different wound dressings. The primary endpoint could not be calculated as intended because the baseline score was not evaluable due to missing values for the one subject that completed follow up. The primary outcome is therefore presented at 12 days. The total of the five scores provide a range from 0 to 15, with higher scores indicating a worse outcome. The primary endpoint was assessed through the change in the sum of Peri-Wound Skin outcome scores (0-15) collected at each visit (Visit 1 (baseline), Visit 2 (day 4), Visit 3 (day 7), Visit 4 last visit (day 12)) from baseline to termination. The sum of scores will be obtained from five separate data scores, Redness/Irritation, Flaky, Maceration, Blistering, Skin tears, which will be scored separately with a value between 0 and 3 (None=0, Mild=1, Moderate=2, Severe=3).
Time Frame	Visit 4 last visit (day 12)

Outcome Measure Data

Analysis Population Description

No statistical evaluation was performed because only 2 subjects were included into the study and 1 completed follow up (other subject withdrew consent). Due to missing values for the one subject that completed follow up, the primary outcome is presented at 12 days.

Arm/Group Title	Avance® Film With Safetac®
Arm/Group Description	Sterile soft silicon adhesive dressing Silicon adhesive dressing: Sterile soft silicon adhesive dressing
Measure Participants	1
Number [score on a scale]	3

2. Secondary Outcome

Title	VAS Scale (0-100mm)
Description	Pain level before, during and after dressing removal. A visual analog scale (VAS) was used by the subjects to assess pain, with a range from 0 to 100, where 100 indicates the worst possible pain.
Time Frame	0-12 days. Visit 1 (baseline), Visit 2 (day 4), Visit 3 (day 7), Visit 4 last visit (day 12)

Outcome Measure Data

Analysis Population Description

No statistical evaluation was performed because only 2 subjects were included into the study and 1 completed follow up (other subject withdrew consent). All data is presented for the one subject throughout their follow up of 4 visits.

Arm/Group Title	Avance® Film With Safetac®
Arm/Group Description	Sterile soft silicon adhesive dressing Silicon adhesive dressing: Sterile soft silicon adhesive dressing
Measure Participants	1
Visit 1: Pain before application of NPWT	3
Visit 2: Pain BEFORE removal of the covering film	2
Visit 2: Pain DURING removal of the covering film	27
Visit 2: Pain AFTER removal of the covering film	2
Visit 2: Pain BEFORE removal of the foam filler	5
Visit 2: Pain DURING removal of the foam filler	2
Visit 2: Pain AFTER removal of the foam filler	2
Visit 3: Pain BEFORE removal of the covering film	19
Visit 3: Pain DURING removal of the covering film	12
Visit 3: Pain AFTER removal of the covering film	10
Visit 3: Pain BEFORE removal of the foam filler	2
Visit 3: Pain DURING removal of the foam filler	5
Visit 3: Pain AFTER removal of the foam filler	5
Visit 4: Pain BEFORE removal of the covering film	4
Visit 4: Pain DURING removal of the covering film	17
Visit 4: Pain AFTER removal of the covering film	17
Visit 4: Pain BEFORE removal of the foam filler	4
Visit 4: Pain DURING removal of the foam filler	6
Visit 4: Pain AFTER removal of the foam filler	9

Adverse Events

Time Frame	First Subject In (FSI): 17 Oct 2016 Last Subject Out (LSO): 18 Apr 2017 The subject was followed for 18 days for AE/SAE.
Arm/Group Title	Avance® Film With Safetac®
Arm/Group Description	Sterile soft silicon adhesive dressing Silicon adhesive dressing: Sterile soft silicon adhesive dressing
All Cause Mortality
	Avance® Film With Safetac®
	Affected / at Risk (%)	# Events
Total	0/2 (0%)
Serious Adverse Events
	Avance® Film With Safetac®
	Affected / at Risk (%)	# Events
Total	0/2 (0%)
Other (Not Including Serious) Adverse Events
	Avance® Film With Safetac®
	Affected / at Risk (%)	# Events
Total	1/2 (50%)
Skin and subcutaneous tissue disorders
Blisters	1/2 (50%)	1

Limitations/Caveats

Early termination of the study due to slow enrollment. Because baseline score was not evaluable for the one subject that completed follow up, primary outcome is presented at 12 days, and not as intended as the change from baseline to last visit.

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.