Clinical Trial

Tumescence in HNC Skin Graft Reconstruction

Active, Not Recruiting Phase 3
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Summary
Our primary objective is to determine if the use of tumescence has a meaningful effect on STSG uptake at the recipient site. This is an important outcome because poor graft uptake results in the need for prolonged local wound care, additional clinic visits for patients and increased risk of infection. A prospective, randomized comparison of the tumescence to our current standard of care will allow us to definitively evaluate any benefits to this technique. Tumescence is commonly used in the treatment of burn patients to minimize blood loss during both tangential excision of eschar and during harvest of split-thickness grafts for reconstruction. This is considered the standard of care in burn surgery as using tumescence has been clearly demonstrated to reduce intraoperative blood loss during harvest of large skin grafts and excision of large burns when compared with the application of topical epinephrine as was the historic standard practice.4-6 Tumescence also creates a firm and uniform surface from which to harvest the skin graft, which the investigators believe may improve the quality of harvest and rate of skin graft take.
Protocol Amendment History 7 amendments
This ClinicalTrials.gov record has been amended 7 times since 2021-07-08; most recent amendment 2026-02-13.
Status change: Recruiting → Active, Not Recruiting 2026-02-13
Status change: Not Yet Recruiting → Recruiting 2021-12-16
Trial Details
NCT Number NCT04967391
Lead Sponsor University of California, Davis
Conditions Head and Neck Cancer, Surgery--Complications, Graft Failure
Enrollment 58 participants
Start Date 2021-09-01
Primary Completion 2026-08-30 (estimated)
Study Completion 2026-08-30 (estimated)
Updated on ClinicalTrials.gov 2026-02-18