NCT02718625

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

A Randomized Controlled Trial of Enzymatic Debridement of Pressure Ulcers With Clostridial Collagenase Ointment (SANTYL®) or Hydrogel (SoloSite®)

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Smith & Nephew, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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®.

Conditions

• Pressure Ulcer

Interventions

Type	Name	Description
BIOLOGICAL	Santyl	Collagenase ointment applied topically
BIOLOGICAL	SoloSite®	SOLOSITE is a hydrogel wound dressing with preservatives. It can donate moisture to rehydrate non-viable tissue. It absorbs exudate while retaining its structure in the wound.

Timeline

• Start date: 2016-08-01
• Primary completion: 2017-03-09
• Completion: 2017-03-09
• First posted: 2016-03-24
• Last updated: 2020-03-10
• Results posted: 2020-03-10

Locations

1 site across 1 country: United States