Treatment of Wounds With a New Adhesive Foam Dressing

Smith & Nephew

Status

Completed

Conditions

Burns

Wounds and Injuries

Treatments

Device: ELECT

Study type

Interventional

Funder types

Industry

Identifiers

NCT02807584

CE053ELE

Details and patient eligibility

About

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.

Enrollment

25 patients

Sex

All

Ages

1+ year old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

INCLUSION CRITERIA

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.

EXCLUSION CRITERIA

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