Trial intelligence / Profile preview

Santyl vs SoloSite for Pressure Ulcer Debridement

NCT02718625Phase 4

Key facts

Status: Terminated
Start: Aug 2016
Primary completion: Mar 2017
Countries: 1
Sponsor: Smith & Nephew
Modality: Therapeutic Enzymes

Drugs: collagenase
Conditions: pressure ulcer

Overview

Phase 4, randomised, single-blind trial of collagenase in pressure ulcer (2 arms), sponsored by Smith & Nephew. Primary endpoint: Proportion of Ulcers With Complete Debridement at 6 weeks. Started Aug 2016; status: terminated.

Design

2 arms

Study design: RandomizedSingle-blind

Santyl Arm
Santyl collagenase ointment applied topically once per day.
SoloSite Arm
SoloSite hydrogel wound dressing applied topically.

Endpoints

Primary

Proportion of Ulcers With Complete Debridement6 weeks

Secondary

Time in Days to Complete Debridement6 weeks
Percentage Reduction in Non-viable Tissue6 weeks
Percentage Reduction in Ulcer Area6 weeks
Pressure Ulcer Scale for Healing6 weeks
Wound Bed Score6 weeks

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