Clinical Investigation of Two Different Wound Dressings

NCT ID: NCT02904200

Last Updated: 2021-04-01

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-31
• Study Completion Date: 2017-05-31

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.

Conditions

Wounds and Injuries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Silicon adhesive dressing

Sterile soft silicon adhesive dressing

Group Type: EXPERIMENTAL

Silicon adhesive dressing

Intervention Type: DEVICE

Sterile soft silicon adhesive dressing

Acrylic adhesive dressing

Sterile acrylic adhesive dressing

Group Type: ACTIVE_COMPARATOR

Acrylic adhesive dressing

Intervention Type: DEVICE

Sterile acrylic adhesive dressing

Interventions

Silicon adhesive dressing

Sterile soft silicon adhesive dressing

Intervention Type: DEVICE

Acrylic adhesive dressing

Sterile acrylic adhesive dressing

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Molnlycke Health Care AB

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marianne Bergstrom

Role: PRINCIPAL_INVESTIGATOR

Sundsvalls Sjukhus

Locations

Sundsvalls sjukhus

Sundsvall, , Sweden

Norrlands Universitetssjukhus

Umeå, , Sweden

Countries

Sweden

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Avance 02

Identifier Type: -

Identifier Source: org_study_id