Treatment of Wounds With a New Adhesive Foam Dressing

Not Applicable

Completed

• Conditions: Wounds and Injuries; Burns
• Interventions: Device: ELECT

• Registration Number: NCT02807584
• Lead Sponsor: Smith & Nephew, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03
• Study First Submitted: 2016-06-14
• Study First Submitted QC: 2016-06-16
• Study First Posted: 2016-06-21
• Primary Completion: 2016-07
• Study Completion: 2016-07
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-14
• Last Update Posted: 2018-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ELECT	ELECT	Adhesive Foam Dressing

Primary Outcome Measures

Name	Time	Method
Wound progression, (percentage change in area) using a wound imaging measurement and wound documentation system	14 days	using a wound imaging, measurement and wound documentation system

Secondary Outcome Measures

Name	Time	Method
Reason for dressing change	14 days
Duration of dressing wear	14 days
Assessment of exudate type and amount	14 days	Assessment using a modified Bates-Jensen Would Assessment Tool1 and T.I.M.E.2,3)
Pain on application and removal of dressing (using a Visual Analogue Scale (VAS) or FLACC scale)	14 days
Percentage change in wound depth	14 days
The proportion of wounds that have 100% healed or closed by secondary intention.	14 days
Ease of application and removal of the ELECT dressing using the visual analogue scale	14 days
Clinician acceptability with dressing performance parameters	14 days	Measured using a questionnaire
Percentage change in wound volume	14 days
Assessment of Condition of the peri-wound skin	14 days	Assessment using a modified Bates-Jensen Would Assessment Tool1 and T.I.M.E.2,3)
Assessment of the amount of tissue and skin colour	14 days	Assessment using a modified Bates-Jensen Would Assessment Tool1 and T.I.M.E.2,3)
Assessment of infection/clinical signs of infection	14 days	Assessment using Normal Clinical practice
Overall clinician acceptability with the new dressing	14 days	Measured using a questionnaire
Safety in use - all adverse events that occur during the study will be recorded	14 days

Trial Locations

Locations (1)

Inkosi Albert Luthuli Central Hospital (IALCH); 🇿🇦 Durban, South Africa