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Clinical Investigation of Two Different Wound Dressings

Primary Purpose

Wounds and Injuries

Status
Terminated
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Silicon adhesive dressing
Acrylic adhesive dressing
Sponsored by
Molnlycke Health Care AB
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Wounds and Injuries

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Sundsvalls sjukhus
  • Norrlands Universitetssjukhus

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Silicon adhesive dressing

Acrylic adhesive dressing

Arm Description

Sterile soft silicon adhesive dressing

Sterile acrylic adhesive dressing

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.

Full Information

First Posted
September 13, 2016
Last Updated
March 5, 2021
Sponsor
Molnlycke Health Care AB
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1. Study Identification

Unique Protocol Identification Number
NCT02904200
Brief Title
Clinical Investigation of Two Different Wound Dressings
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Terminated
Study Start Date
October 2016 (Actual)
Primary Completion Date
May 2017 (Actual)
Study Completion Date
May 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Molnlycke Health Care AB

4. Oversight

Data Monitoring Committee
No

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wounds and Injuries

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Silicon adhesive dressing
Arm Type
Experimental
Arm Description
Sterile soft silicon adhesive dressing
Arm Title
Acrylic adhesive dressing
Arm Type
Active Comparator
Arm Description
Sterile acrylic adhesive dressing
Intervention Type
Device
Intervention Name(s)
Silicon adhesive dressing
Intervention Description
Sterile soft silicon adhesive dressing
Intervention Type
Device
Intervention Name(s)
Acrylic adhesive dressing
Intervention Description
Sterile acrylic adhesive dressing
Primary Outcome Measure Information:
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)
Secondary Outcome Measure Information:
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Traumatic, surgical or dehisced wounds, Venous Leg Ulcer, Diabetic Foot Ulcer or Pressure Ulcer indicated for treatment with NPWT therapy 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. Peri-wound skin assessable and 5 cm of peri-wound skin present around the wound Male or female, 18 years of age and above Signed Informed Consent Exclusion Criteria: Dressing sizes does not fit the target wound Unexplored blind tunnels or non-enteric fistula Untreated osteomyelitis Malignant wounds Subjects treated with systemic immunosuppressive or glucocorticosteroids, except subjects taking occasional doses or doses less than 10mg prednisolon/day or equivalent. Wounds with necrotic tissue or eschar (if not adequately debrided) Significantly bleeding wounds, as judged by the investigator Subject not suitable for the investigation according to the investigator's judgment Subject included in other ongoing clinical investigation which could interfere with this investigation, as judged by the investigator Known allergy/hypersensitivity to any of the components included into the investigation.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marianne Bergstrom
Organizational Affiliation
Sundsvalls Sjukhus
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sundsvalls sjukhus
City
Sundsvall
Country
Sweden
Facility Name
Norrlands Universitetssjukhus
City
Umea
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No

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Clinical Investigation of Two Different Wound Dressings

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