Test of the Safety, Effectiveness, & Acceptability of An Improvised Dressing for Sickle Cell Leg Ulcers in the Tropics

NACompletedINTERVENTIONAL
Enrollment

48

Participants

Timeline

Start Date

July 6, 2021

Primary Completion Date

November 20, 2021

Study Completion Date

February 20, 2022

Conditions
Sickle Cell Leg Ulcer
Interventions
DEVICE

Usual Practice

A saline soaked piece of gauze, conformed to the size of the open ulcer area, will be placed over the ulcer and held in place with a wrap of stretch gauze. Ulcers will be rinsed with saline at daily dressing changes, which will be conducted by the patient after they master the procedure.

DEVICE

Improvised dressing

A piece of a new food-grade plastic bag, cut slightly larger than the ulcer, will be placed over the ulcer, sealed at the edges with an emollient to create an occlusive dressing. The dressing will be gently conformed to the ulcer contours to eliminate dead space, and a slit will be cut in the center to allow excess fluid to escape into a clean absorbent material placed over the slit. The device will be held in place with a wrap of stretch gauze. Ulcers will be rinsed with saline at daily dressing changes, which will be conducted by the patient after they master the procedure.

DEVICE

Advanced dressing

A piece of polymeric membrane dressing, cut to extend at least 0.5cm beyond the open ulcer edges, will be placed over the ulcer and held in place with a wrap of stretch gauze. The approximate wound edges will be marked on the back of the dressing. Dressing changes will consist only of removing the dressing when the saturation level, visible through the wound backing, reaches the mark indicating the dressing edges and applying a new cut dressing. Changes will be conducted by the patient after they master the procedure.

Trial Locations (1)

Unknown

University Hospital of the West Indies, Mona

All Listed Sponsors
collaborator

Wound Healing Foundation

OTHER

collaborator

University Hospital of the West Indies

OTHER

collaborator

The University of The West Indies

OTHER

collaborator

Ferris Mfg. Corp.

INDUSTRY

lead

Benskin, Linda, PhD, RN, SRN (Ghana), CWCN, CWS, DAPWCA

OTHER