Utility of Restrata With Split Thickness Skin Graft to Reconstruct the Forearm Donor Site
Not Applicable
Terminated
- Conditions
- Wound Heal
- Registration Number
- NCT04829331
- Lead Sponsor
- Acera Surgical, Inc.
- Brief Summary
Understand association between use of Restrata (Acera Surgical Inc., St. Louis, MO) in forearm flap reconstruction with donor site healing and function
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 5
Inclusion Criteria
- All patients age 19 or greater that will undergo radial forearm free flap or ulnar free flap.
- Photo documentation of wound bed at two weeks and four weeks must be obtainable either by physician or patient.
Exclusion Criteria
- Active systemic immunosuppression (active use of high-dose steroids (≥40mg prednisone daily or equivalent) or other immunosuppressive medications OR medical conditions causing immunosuppression, i.e. human immunodeficiency virus etc).
- Diabetes mellitus with most recent Hemoglobin A1c ≥10.0 within 30 days prior to surgery.
- Morbid obesity (BMI >40).
- Inability to maintain wrist immobilization for full planned period.
- Severe malnutrition (prealbumin levels <10 mg per dL within 30 days prior to surgery OR BMI <15 (very severely underweight).
- Other conditions felt to significantly impair wound healing per surgeon discretion.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Tendon Exposure 4 weeks post-operatively Percentage of participants with tendon exposure
Surface Area of Split-thickness Skin Graft Incorporation 4 weeks post-operatively Percentage of surface area of split-thickness skin graft incorporation
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie Restrata's role in enhancing split thickness skin graft healing for forearm donor sites?
How does Restrata compare to standard-of-care donor site management in terms of functional outcomes and wound healing rates?
Which biomarkers correlate with improved tissue regeneration when using Restrata in split thickness skin graft procedures?
What are the potential adverse events associated with Restrata in forearm donor site reconstruction and their mitigation strategies?
Are there alternative biomaterials or combination therapies to Restrata for optimizing split thickness skin graft integration in wound healing?
Trial Locations
- Locations (1)
Nebraska Methodist Hospital
🇺🇸Omaha, Nebraska, United States
Nebraska Methodist Hospital🇺🇸Omaha, Nebraska, United States