Treatment of Wounds With a New Adhesive Foam Dressing

A Prospective, Open Study to Evaluate the Clinical Performance of a New Adhesive Foam Dressing in the Treatment of Partial Thickness Burns, Acute and Chronic Wounds.

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.

Study Overview

• Status: Completed
• Conditions: Wounds and Injuries; Burns
• Intervention / Treatment: Device: ELECT

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• South Africa
  • Durban, South Africa, 4058
    • Inkosi Albert Luthuli Central Hospital (IALCH)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ELECT; Adhesive Foam Dressing	Device: ELECT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Assessment using a modified Bates-Jensen Would Assessment Tool1 and T.I.M.E.2,3)	14 days
Assessment of Condition of the peri-wound skin	Assessment using a modified Bates-Jensen Would Assessment Tool1 and T.I.M.E.2,3)	14 days
Assessment of the amount of tissue and skin colour	Assessment using a modified Bates-Jensen Would Assessment Tool1 and T.I.M.E.2,3)	14 days
Assessment of infection/clinical signs of infection	Assessment using Normal Clinical practice	14 days
Pain on application and removal of dressing (using a Visual Analogue Scale (VAS) or FLACC scale)		14 days
Reason for dressing change		14 days
Ease of application and removal of the ELECT dressing using the visual analogue scale		14 days
Overall clinician acceptability with the new dressing	Measured using a questionnaire	14 days
Clinician acceptability with dressing performance parameters	Measured using a questionnaire	14 days
Safety in use - all adverse events that occur during the study will be recorded		14 days

Collaborators and Investigators

• Sponsor: Smith & Nephew, Inc.
• Investigators: Principal Investigator: Alessandro Andreone, MD, Inkosi Albert Luthuli Central Hospital (IALCH)

Study record dates

Study Major Dates

• Study Start: March 1, 2016
• Primary Completion (Actual): July 1, 2016
• Study Completion (Actual): July 1, 2016

Study Registration Dates

• First Submitted: June 14, 2016
• First Submitted That Met QC Criteria: June 16, 2016
• First Posted (Estimate): June 21, 2016

Study Record Updates

• Last Update Posted (Actual): February 19, 2018
• Last Update Submitted That Met QC Criteria: February 14, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: acute; chronic; burns; dressing; Wound; foam; adhesive
• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: CE053ELE