Treatment of Wounds With a New Adhesive Foam Dressing

NCT ID: NCT02807584

Last Updated: 2018-02-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2016-07-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ELECT

Adhesive Foam Dressing

Group Type: EXPERIMENTAL

ELECT

Intervention Type: DEVICE

Interventions

ELECT

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Participants must be ≥1 years old

2. Males and females (females must not be pregnant and must use contraception if of child bearing potential)

3. 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

4. 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)

5. 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).

6. The participant or the participant's legal representative is able to understand and is willing to consent to the study.

Exclusion Criteria

1. 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)

2. Participants who are unable to understand the aims and objectives of the study.

3. Participant is a prisoner.

4. Participants with a known sensitivity to any of the constituents of the evaluation products, including polyester, polyurethane, and acrylic adhesive

5. Participants with facial wounds as the reference wound

6. Participants with confirmed or suspected clinically infected reference wounds (unless wounds are being treated per standard protocol for wound infection)

7. Participant is likely to undergo foreseeable definitive surgery within 2 weeks from screening

8. Participants where a reference wound cannot be treated in isolation from other wounds

9. Participants who have participated in this evaluation previously and closed/100% healed, or have been withdrawn from the study, or any previous studies

10. Participant who are employees of Smith & Nephew group companies

• Minimum Eligible Age: 1 Year
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Smith & Nephew, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Herbert B Slade, MD

Role: STUDY_CHAIR

Smith & Nephew, Inc.

Jaime E Dickerson, PhD

Role: STUDY_DIRECTOR

Smith & Nephew, Inc.

Alessandro Andreone, MD

Role: PRINCIPAL_INVESTIGATOR

Inkosi Albert Luthuli Central Hospital (IALCH)

Locations

Inkosi Albert Luthuli Central Hospital (IALCH)

Durban, , South Africa

Countries

South Africa

Other Identifiers

CE053ELE

Identifier Type: -

Identifier Source: org_study_id