NCT04967391Active, not recruitingPhase 3
Tumescence in HNC Skin Graft Reconstruction
The Role Of Tumescence In Split Thickness Skin Grafting For Reconstruction Of Head And Neck Cancer Resection
Source: ClinicalTrials.gov · Last updated 18 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 58 (estimated)
- First submitted
- 21 Jun 2021
- Start date
- 1 Sept 2021
- Primary completion date
- 30 Aug 2026
- Lead sponsor
- University of California, Davis
- Diseases
- Head and neck cancer
- NCT number
- NCT04967391
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 58
- From 1 Sept 2021 to the primary completion date, 30 Aug 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of prior radiation.
- Severe infection that in the opinion of the investigator would interfere with patient safety or compliance on trial within 4 weeks prior to enrollment.
Other illness
- Any significant medical condition which, in the opinion of the investigator, will not be appropriate for the study.
Other
- Pregnant or lactating women.
Who the study is looking for
- Ability to adhere to the study visit schedule and other protocol requirements.
- Men and women ≥18 years of age.
- Life expectancy ≥ 3 months.
- 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.
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UC Davis Health Coordinator of this site? Confirm its status | Sacramento | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.