|

Tumescence in HNC Skin Graft Reconstruction

RECRUITINGPhase 3Sponsored by University of California, Davis
Actively Recruiting
PhasePhase 3
SponsorUniversity of California, Davis
Started2021-09-01
Est. completion2025-08-30
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations1 site

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.

Eligibility

Age: 18 Years+Healthy volunteers accepted
Inclusion Criteria Patients must meet all of the following criteria to be eligible for study entry.

1. Ability to adhere to the study visit schedule and other protocol requirements.
2. Men and women ≥18 years of age.
3. Life expectancy ≥ 3 months.
4. Planned surgery for head and neck cancer ablation requiring split-thickness skin grafting for reconstruction of free flap donor sites from the forearm and fibula.

Exclusion Criteria Patients who meet any of the following criteria will be excluded from study entry.

1. Pregnant or lactating women.
2. History of prior radiation.
3. Any significant medical condition which, in the opinion of the investigator, will not be appropriate for the study.
4. Severe infection that in the opinion of the investigator would interfere with patient safety or compliance on trial within 4 weeks prior to enrollment.

Conditions4

CancerGraft FailureHead and Neck CancerSurgery--Complications

Locations1 site

UC Davis Health
Sacramento, California, 95817
Marianne Abouyared, MD916-734-2704mabouyared@ucdavis.edu

Browse More Trials

Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

This site does not provide medical advice. Always consult your doctor before considering enrollment in a clinical trial. Learn more on our About page.