Treatment of Wounds With a New Adhesive Foam Dressing

NCT02807584 | Completed

• 1 other identifier: CE053ELE
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

This study will look at whether ELECT, a new adhesive foam dressing, can offer an alternative to traditional wound care methods. Patients will be treated with ELECT for 14 days. Data relating to wound healing, the performance of the dressing and the opinion of the doctor will be collected. The hypothesis of this study is that the ELECT foam adhesive dressing is 'fit for purpose' and will be effective at treating a variety of wounds.

Conditions

Wounds and Injuries; Burns

Keywords

Wound; burns; acute; chronic; foam; adhesive; dressing

Outcome Measures

Primary Outcomes (1)

• Wound progression, (percentage change in area) using a wound imaging measurement and wound documentation system

  using a wound imaging, measurement and wound documentation system

  14 days

Secondary Outcomes (14)

• Percentage change in wound depth

  14 days

• Percentage change in wound volume

  14 days

• Duration of dressing wear

  14 days

• The proportion of wounds that have 100% healed or closed by secondary intention.

  14 days

• Assessment of exudate type and amount

  14 days

Study Arms (1)

ELECT

EXPERIMENTAL

Adhesive Foam Dressing

Device: ELECT

Interventions

ELECT DEVICE

ELECT

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must be ≥1 years old
• Males and females (females must not be pregnant and must use contraception if of child bearing potential)
• Participant must have a partial thickness burn, acute or chronic wound that would benefit from the application of an advanced wound dressing to help facilitate moist wound healing
• Presence of a suitable wound which can be treated with the available sizes of the ELECT Adhesive Foam Dressing (7.5cm x 7.5cm, 12.5cm x 12.5cm, 15cm x 15cm and 17.5cm x 17.5cm)
• Participant is under the direct observation of the investigator for the duration of the study (i.e the participant's wound must not be treated by another clinician throughout the duration of the study).
• The participant or the participant's legal representative is able to understand and is willing to consent to the study.

You may not qualify if:

• Participants with a known history of poor compliance with treatment (including if the participant has a known , diagnosed emotional or neurological condition such as mental disorders/illnesses, mental retardation, drug or alcohol abuse, that would pre-empt their ability to understand and consent)
• Participants who are unable to understand the aims and objectives of the study.
• Participant is a prisoner.
• Participants with a known sensitivity to any of the constituents of the evaluation products, including polyester, polyurethane, and acrylic adhesive
• Participants with facial wounds as the reference wound
• Participants with confirmed or suspected clinically infected reference wounds (unless wounds are being treated per standard protocol for wound infection)
• Participant is likely to undergo foreseeable definitive surgery within 2 weeks from screening
• Participants where a reference wound cannot be treated in isolation from other wounds
• Participants who have participated in this evaluation previously and closed/100% healed, or have been withdrawn from the study, or any previous studies
• Participant who are employees of Smith \& Nephew group companies

Sponsors & Collaborators

• Smith & Nephew, Inc.: lead

Study Sites (1)

Inkosi Albert Luthuli Central Hospital (IALCH)

Durban, 4058, South Africa

Location

MeSH Terms

Conditions

Wounds and Injuries; Burns; Bronchiolitis Obliterans Syndrome

Condition Hierarchy (Ancestors)

Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Study Officials

• Herbert B Slade, MD

  Smith & Nephew, Inc.

  STUDY CHAIR

• Jaime E Dickerson, PhD

  Smith & Nephew, Inc.

  STUDY DIRECTOR

• Alessandro Andreone, MD

  Inkosi Albert Luthuli Central Hospital (IALCH)

  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 14, 2016
• First Posted: June 21, 2016
• Study Start: March 1, 2016
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: February 19, 2018

Record last verified: 2018-02

Locations

ZA (1)