ACTICOAT™ for the Treatment of Burns and Chronic Wounds

NCT02852148 | Completed

• 1 other identifier: CT1601ACT
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Wounds and Injuries; Burns; Pressure Ulcer; Foot Ulcer

Keywords

Wound; Pressure Ulcer; Diabetic Foot Ulcer; Venous Leg Ulcer; Burn; Quality of Life

Outcome Measures

Primary Outcomes (1)

• Change in EQ-5D 5L mean single index utility scores (EuroQol Research Foundation 2015).

  21 days

Secondary Outcomes (15)

• Clinical signs and symptoms of infection

  21 days

• Wound length

  21 days

• Wound width

  21 days

• Wound depth

  21 days

• Reference wound healed (% re-epithelialized)

  21 days

Study Arms (1)

ACTICOAT

EXPERIMENTAL

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.

Device: ACTICOAT

Interventions

ACTICOAT DEVICE

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.

ACTICOAT

Eligibility Criteria

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

You may qualify if:

• Must provide informed consent to participate in the study.
• Eighteen (18) years of age or older.
• Males and females.
• Able to follow instructions and be deemed capable of completing the EQ-5D 5L Questionnaire appropriately.
• Willing and able to make all required study visits, and provide a daytime telephone number on which they can be contacted directly.
• Presenting with either a chronic wound or burn which is deemed suitable for treatment with ACTICOAT and meets either of the following requirements:
• A full or partial thickness chronic (≥ 4 weeks duration) wound, consisting of a Venous Leg Ulcer, Pressure Ulcer or Diabetic Foot Ulcer, which in the opinion of the Investigator, or delegated Sub-Investigator, appears to be infected based on documented clinical signs and symptoms of infection.
• A recently acquired (≤ 7 days) non-infected burn, comprising a full or partial thickness wound, covering a minimum 0.5% TBSA. The maximum must be less than 10% TBSA. Absence of infection will be determined by the Investigator / Sub-Investigator.

You may not qualify if:

• Contraindications or hypersensitivity to the use of the test article, ancillary products or their components (e.g., known sensitivity to silver).
• Participation in the treatment period of another clinical trial within thirty (30) days of Visit 1.
• Treatment with any other silver dressing (i.e. non ACTICOAT dressing) within seven (7) days of Visit 1.
• Patients with skin features which in the opinion of the Investigator, will interfere with the study assessments.
• Patients requiring concomitant use of NPWT on the reference wound.
• Patients who have participated previously in this clinical trial and who have healed or been withdrawn.
• Patients with a history of poor compliance with medical treatment.
• Patients who, in the opinion of the Investigator, are experiencing burn shock.
• Patients with any other medical or physical condition that, in the opinion of the Investigator, would preclude safe subject participation in the study.

Sponsors & Collaborators

• Smith & Nephew, Inc.: lead

Study Sites (3)

Northumbria Healthcare NHS Foundation Trust

Ashington, NE630HP, United Kingdom

Location

Leeds Wounds Research Unit

Leeds, LS12 3QE, United Kingdom

Location

The Mid Yorkshire Hospitals NHS Trust

Wakefield, WF1 4EE, United Kingdom

Location

MeSH Terms

Conditions

Wounds and Injuries; Burns; Pressure Ulcer; Foot Ulcer; Diabetic Foot; Varicose Ulcer

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Foot Diseases; Leg Ulcer; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies; Varicose Veins

Study Officials

• Beate Hanson, VP, PhD

  Smith & Nephew, Inc.

  STUDY CHAIR

• Lyn Wilson, MA

  Pinderfield Hospitals

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: June 24, 2016
• First Posted: August 2, 2016
• Study Start: November 1, 2016
• Primary Completion: November 28, 2017
• Study Completion: December 13, 2017
• Last Updated: April 4, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (3)