Clinical trial · Interventional
Utility of Restrata With Split-thickness Skin Graft to Reconstruct the Forearm Donor Site
NCT04880603CI-TRIAL-00058480terminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Investigators no longer interested in pursuing
Summary
Brief summary (as posted)
Adult patients undergoing a radial forearm free flap or ulnar forearm free flap will be randomized to the use of the Restrata graft in combination with split-thickness skin graft for reconstruction. Photos will document whether the Restata graft aids in the healing.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Restrata Graft | Device | — | UNRESOLVED |
| Standard of Care Skin Graft | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- A - Standard of Care
- interventionNames
- Procedure: Standard of Care Skin Graft
- type
- EXPERIMENTAL
- label
- B - Restrata Graft
- interventionNames
- Device: Restrata Graft
Primary outcomes (2)
- measure
- Tendon exposure
- timeFrame
- 4 weeks post-operation
- description
- Tendon exposure at four weeks post-operatively (Yes/No).
- measure
- Percentage of surface area
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.