NCT02852148

ACTICOAT™ for the Treatment of Burns and Chronic Wounds

A Prospective, Non-comparative, Multicentre Study to Evaluate a Silver Coated Antimicrobial Barrier Wound Dressing (ACTICOAT™) in the Treatment of Burns and Chronic Wounds.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Smith & Nephew, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of the study is to evaluate participant reported quality of life, safety, and overall performance with ACTICOAT in a clinical setting.

Detailed description

ACTICOAT is a silver coated antimicrobial barrier wound dressing for the treatment of a variety of wound types. It is widely used in routine clinical practice within the UK. ACTICOAT is CE marked and will be used within the intended indications for use. The proposed study is required for regulatory purposes. Primary Objective: To evaluate change in health related quality of life, associated with treatment. The primary outcome measure / endpoint will be change in EQ-5D 5L mean single index utility scores from baseline to 3 weeks. The study will also seek to gather and report relevant safety and performance data and evaluate change, where applicable, for outcomes including: clinical signs and symptoms of infection; wound length / width / depth; wound healing measures; tissue staining; pain, adherence, and pain on application / removal; wear time; adverse events and device deficiencies. In total 25 participants will be recruited into the trial, comprising a minimum of 8 participants with a full or partial thickness burn and a minimum of 8 participants with a full or partial thickness chronic wound. All participants will have their wound dressed using ACTICOAT, and will be followed-up for 3 weeks.

Conditions

• Wounds and Injuries
• Burns
• Pressure Ulcer
• Foot Ulcer

Interventions

Type	Name	Description
DEVICE	ACTICOAT	ACTICOAT is a silver coated antimicrobial barrier dressing. ACTICOAT dressings consist of three layers: an absorbent inner core of polyester and rayon sandwiched between outer layers of silver coated, low adherent, high density polyethylene mesh.

Timeline

• Start date: 2016-11-01
• Primary completion: 2017-11-28
• Completion: 2017-12-13
• First posted: 2016-08-02
• Last updated: 2019-04-04

Locations

3 sites across 1 country: United Kingdom