Clinical Investigation of Two Different Wound Dressings

NCT02904200 | Terminated Results

• 1 other identifier: Avance 02
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 2

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

Conditions

Wounds and Injuries

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (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)

Study Arms (2)

Silicon adhesive dressing

EXPERIMENTAL

Sterile soft silicon adhesive dressing

Device: Silicon adhesive dressing

Acrylic adhesive dressing

ACTIVE COMPARATOR

Sterile acrylic adhesive dressing

Device: Acrylic adhesive dressing

Interventions

Silicon adhesive dressing DEVICE

Sterile soft silicon adhesive dressing

Silicon adhesive dressing

Acrylic adhesive dressing DEVICE

Sterile acrylic adhesive dressing

Acrylic adhesive dressing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Molnlycke Health Care AB: lead

Study Sites (2)

Sundsvalls sjukhus

Sundsvall, Sweden

Location

Norrlands Universitetssjukhus

Umeå, Sweden

Location

MeSH Terms

Conditions

Wounds and Injuries

Limitations and 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.

Results Point of Contact

• Title: Global Clinical Research Director
• Organization: Mölnlycke Health Care

info@monlycke.com

+46 31 722 30 00

Study Officials

• Marianne Bergstrom

  Sundsvalls Sjukhus

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2016
• First Posted: September 16, 2016
• Study Start: October 1, 2016
• Primary Completion: May 1, 2017
• Study Completion: May 1, 2017
• Last Updated: April 1, 2021
• Results First Posted: April 1, 2021

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

SE (2)