N/A
N=19
Evaluation of Opticell Ag on Split-Thickness Skin Graft Donor Sites in Adult Subjects
Split-thickness Skin Graft Donor Sites
Bottom Line
View on ClinicalTrials.gov: NCT02642679 ↗Enrolled (actual)
19
Serious AEs
0.0%
Results posted
Dec 2017
Primary outcome: Primary: Pain — 4.2; 2.5; 1.1 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Opticell Ag (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Brigham and Women's Hospital
- Primary completion
- Oct 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain |
4.2; 2.5; 1.1 | — |
| PRIMARY Wound Healing Rate (Re-epithelialization) |
92.3; 99.5 | — |
| SECONDARY Wound Healing Quality |
3 | — |
Summary
The purpose of this single center, prospective case series is to evaluate the effective management of split-thickness skin graft donor site wounds using Opticell Ag (Chitosan-based dressing).
Eligibility Criteria
Inclusion Criteria
- Inpatient status at study site
- Subject must be receiving a split-thickness skin graft (STSG)
- Wounds must not exceed 10% total body surface area (TBSA)
- Any donor site
- Ability to comply with necessary wound care/follow up
Exclusion Criteria
- Subject is pregnant
- Subject has been diagnosed with Diabetes
- Subject is a smoker
- Subject takes steroids
- Subject is sensitive and/or allergic to shellfish and/or silver
- Wounds that exceed 10% total body surface area (TBSA)
- Inability to comply with necessary wound care/follow up
Data sourced from ClinicalTrials.gov (NCT02642679). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.