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.

Smith & Nephew, Inc.1 site in 1 country25 target enrollmentMarch 2016

ConditionsWounds and Injuries Burns

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Wounds and Injuries
Sponsor: Smith & Nephew, Inc.
Enrollment: 25
Locations: 1
Primary Endpoint: Wound progression, (percentage change in area) using a wound imaging measurement and wound documentation system
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 2016

End Date

July 2016

Last Updated

8 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Smith & Nephew, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Outcomes

Primary Outcomes

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

Time Frame: 14 days

using a wound imaging, measurement and wound documentation system

Secondary Outcomes

Pain on application and removal of dressing (using a Visual Analogue Scale (VAS) or FLACC scale)(14 days)
Duration of dressing wear(14 days)
Assessment of exudate type and amount(14 days)
Percentage change in wound depth(14 days)
The proportion of wounds that have 100% healed or closed by secondary intention.(14 days)
Percentage change in wound volume(14 days)
Assessment of Condition of the peri-wound skin(14 days)
Assessment of the amount of tissue and skin colour(14 days)
Reason for dressing change(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)
Assessment of infection/clinical signs of infection(14 days)
Overall clinician acceptability with the new dressing(14 days)
Safety in use - all adverse events that occur during the study will be recorded(14 days)