NCT04967391

Tumescence in HNC Skin Graft Reconstruction

Active, enrolled Phase 3 Last updated 18 February 2026

What this trial tests

Phase 3 trial testing Tumescence During STSG Harvest in Head and Neck Cancer in 58 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

1 September 2021

Primary endpoint
30 August 2026

30 August 2026

Quick facts

Lead sponsor	University of California, Davis
Phase	Phase 3
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	supportive care
Enrollment	58
Start date	1 September 2021
Primary completion	30 August 2026
Estimated completion	30 August 2026
Sites	1 location across United States

Drugs / interventions tested

• Tumescence During STSG Harvest

Conditions studied

• Head and Neck Cancer — all drugs for Head and Neck Cancer →
• Surgery--Complications — all drugs for Surgery--Complications →
• Graft Failure — all drugs for Graft Failure →

Sponsor

University of California, Davis

Who can join

18 and older, any sex, with Head and Neck Cancer or Surgery--Complications. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.