NCT02904200

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Molnlycke Health Care AB · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	Silicon adhesive dressing	Sterile soft silicon adhesive dressing
DEVICE	Acrylic adhesive dressing	Sterile acrylic adhesive dressing

Timeline

• Start date: 2016-10-01
• Primary completion: 2017-05-01
• Completion: 2017-05-01
• First posted: 2016-09-16
• Last updated: 2021-04-01
• Results posted: 2021-04-01

Locations

2 sites across 1 country: Sweden