Clinical Investigation of Two Different Wound Dressings

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

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

Study Overview

• Status: Terminated
• Conditions: Wounds and Injuries
• Intervention / Treatment: Device: Silicon adhesive dressing; Device: Acrylic adhesive dressing

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 Type: Interventional
• Enrollment (Actual): 2
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Sundsvall, Sweden
    • Sundsvalls sjukhus
  • Umea, Sweden
    • Norrlands Universitetssjukhus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes on Peri-Wound Skin	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).	Visit 4 last visit (day 12)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
VAS Scale (0-100mm)	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.	0-12 days. Visit 1 (baseline), Visit 2 (day 4), Visit 3 (day 7), Visit 4 last visit (day 12)

Collaborators and Investigators

• Sponsor: Molnlycke Health Care AB
• Investigators: Principal Investigator: Marianne Bergstrom, Sundsvalls sjukhus

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2016
• Primary Completion (Actual): May 1, 2017
• Study Completion (Actual): May 1, 2017

Study Registration Dates

• First Submitted: September 13, 2016
• First Submitted That Met QC Criteria: September 15, 2016
• First Posted (Estimate): September 16, 2016

Study Record Updates

• Last Update Posted (Actual): April 1, 2021
• Last Update Submitted That Met QC Criteria: March 5, 2021
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Physiological Effects of Drugs; Trace Elements; Micronutrients; Silicon
• Other Study ID Numbers: Avance 02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No