Clinical trial · Interventional
The Use of Integra in Coverage of Radial Forearm Free Flap Donor Site Defect
NCT02980601CI-TRIAL-00038791terminatedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this research study is to compare the forearm free flap of patients with a traditional split thickness skin graft and those repaired with Integra (a skin substitute that helps to provide wound closure) and a split thickness skin graft. The study team will be looking at the subject's satisfaction with how the skin graft site looks and how well the skin graft site is functioning.
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 |
|---|---|---|---|
| Integra plus STSG | Device | — | UNRESOLVED |
| STSG | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Integra and a Split Thickness Skin Graft (STSG)
- description
- A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG.
- interventionNames
- Device: Integra plus STSG
- Procedure: STSG
- type
- ACTIVE_COMPARATOR
- label
- Split Thickness Skin Graft (STSG)
- description
- reconstruction as dictated by the protocol. They will either receive 1) a 0
- interventionNames
- Procedure: STSG
Primary outcomes (39)
- measure
- Number of Participants With Skin Graft Necrosis.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * All subjects who receive a radial forearm free flaps in the included time period, including subjects with head and neck cancer, traumatic defects, chronic wounds, or any other problems that require a radical forearm free flap for reconstruction. * Have had a distal, anterograde fasciocutaneous flap * Age ≥ 18 years * Ability to understand and the willingness to sign an IRB-approved informed consent document. * Smokers and tobacco users will be included in this study Exclusion Criteria: * Subjects who have had an osteocutaneous or musculocutaneous flap. * Subjects who have a radial forearm flap with a proximal skin flap or subjects that receive a "reverse" radial forearm flap * Pregnant women will be excluded due to the lack of clinical studies evaluating INTEGRA template in pregnant women.
References
Publications (0)
Data not yet available
No reference posted for this study.