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

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

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

Brief 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®.

Detailed Summary:
Sponsor: Smith & Nephew, Inc.

Current Primary Outcome: Proportion of ulcers with complete debridement [ Time Frame: 6 weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Time in days to complete debridement [ Time Frame: 6 weeks ]
  • Percentage reduction in non-viable tissue [ Time Frame: 6 weeks ]
  • Percentage reduction in ulcer area [ Time Frame: 6 weeks ]
  • Pressure Ulcer Scale for Healing (PUSH) score [ Time Frame: 6 weeks ]
  • Wound Bed Sore (WBS) score [ Time Frame: 6 weeks ]


Original Secondary Outcome:

  • Time in days to complete debridement [ Time Frame: 6 weeks ]
  • Percentage reduction in non-viable tissue [ Time Frame: 6 weeks ]
  • Percentage reduction in ulcer area [ Time Frame: 6 weeks ]
  • PUSH score [ Time Frame: 6 weeks ]
  • WBS score [ Time Frame: 6 weeks ]


Information By: Smith & Nephew, Inc.

Dates:
Date Received: March 18, 2016
Date Started: August 2016
Date Completion:
Last Updated: March 23, 2017
Last Verified: March 2017