Study of SANTYL® vs Hydrogel (SoloSite®) for Pressure Ulcers
- Conditions
- Pressure Ulcer
- Interventions
- Biological: SoloSite®Biological: Santyl
- Registration Number
- NCT02718625
- Lead Sponsor
- Smith & Nephew, Inc.
- 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 Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 3
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SoloSite® 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. Santyl Santyl Santyl collagenase ointment applied topically once per day for up to six weeks
- Primary Outcome Measures
Name Time Method Proportion of Ulcers With Complete Debridement 6 weeks For purposes of the primary analysis, the status of complete debridement was to be assessed from photographs by two independent reviewers.
- Secondary Outcome Measures
Name Time Method Time in Days to Complete Debridement 6 weeks For purposes of this secondary analysis, the time (in days) to achieve complete debridement (as defined in the primary analysis) was to be calculated from the date of randomization visit to the date of which the subject's ulcer was deemed to have achieved complete debridement.
Percentage Reduction in Ulcer Area 6 weeks For purposes of this secondary analysis, the percentage reduction in ulcer area was to be measured during ulcer photograph review by two independent reviewers, using the ImageIQ EDCIQ mobile imaging system, with the reduction calculated as: (\[ulcer area at Visit 1 - ulcer area at Visit 7 / ulcer area at Visit 1\] x 100).
Pressure Ulcer Scale for Healing (PUSH) Score 6 weeks For purposes of this secondary analysis, changes in wound status were to be measured by using the Pressure Ulcer Scale for Healing (PUSH) Tool. At Visits 1 and 7, the target ulcer was to be scored based on length/width (from 0 cm\^2 to \>24 cm\^2 on a scale of 1 to 10), exudate amount (from 'none' to 'heavy' on a scale of 0 to 3) , and tissue type ('closed' to 'necrotic tissue' on a scale of 0 to 4); from which a total PUSH score from the sum of scores for the three categories could be derived (ranging from 0 to 17). Higher scores indicated a worse response. The reduction in PUSH individual sub-scores and total PUSH scores were calculated as: (PUSH Score at Visit 1 - Push Score at Visit 7/Exit).
Wound Bed Sore (WBS) Score 6 weeks For purposes of this secondary analysis, changes in wound status were to be measured by using the Wound Bed Sore (WBS) score. At Visits 1 and 7, eight individual wound bed sore characteristics were scored, each on a scale of 0 to 2 (higher scores represented better outcomes), and then summed to derive the total WBS score (ranging from 0 to 16). The reduction in total WBS scores were calculated as: (Total WBS Score at Visit 1 - Total WBS Score at Visit 7/Exit).
Percentage Reduction in Non-viable Tissue 6 weeks For purposes of this secondary analysis, the assessment of percentage of non-viable necrotic tissue was to be assessed based on photograph review by two independent reviewers, with the reduction calculated as: percentage of non-viable necrotic tissue at Visit 1 - percentage of non-viable necrotic tissue at Visit 7.