drugset / Trial / NCT02718625

Study of SANTYL® vs Hydrogel (SoloSite®) for Pressure Ulcers

NCT02718625

Phase 4 Terminated 3 enrolled Smith & Nephew, Inc.
RandomizedParallel-groupOpen-labelTreatment

Summary

This study is designed to compare SANTYL® versus hydrogel (SoloSite®) in the treatment of pressure ulcers for participants in a long-term care facility. After meeting study criteria, participants will be randomly assigned for application of SANTYL® or SoloSite® to their pressure ulcer for up to 6 weeks. A study previously conducted showed that in the long-term care setting, the removal of dead skin (debridement) with SANTYL® resulted in more participants achieving complete debridement, more rapidly than when SoloSite® is used. The goal of the present study is to confirm the results of the earlier study, demonstrating superior debridement outcomes for pressure ulcers of patients in long-term care as compared to ulcers managed with SoloSite®.

Timeline

Start
2016-08
Primary completion
2017-03-09
Completion
2017-03-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Collagenase Clostridium Histolyticum Protein / enzyme biologic Topical

Indications