Using tumescence to improve skin graft success in head and neck cancer surgery
The Role Of Tumescence In Split Thickness Skin Grafting For Reconstruction Of Head And Neck Cancer Resection
This study is testing if using tumescence during skin graft surgery can help patients with head and neck cancer have better healing and fewer complications.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 58 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of California, Davis Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Sacramento, California) |
| Trial ID | NCT04967391 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of tumescence in enhancing the uptake of split-thickness skin grafts (STSG) in patients undergoing surgery for head and neck cancer. The study will compare the outcomes of patients receiving tumescence during graft harvesting against those receiving the current standard of care. By minimizing blood loss and potentially improving graft success, this approach could reduce complications such as infection and the need for additional treatments. The trial will involve a randomized, prospective design to ensure robust data collection and analysis.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who are scheduled for surgery to remove head and neck tumors and require skin grafting for reconstruction.
Not a fit: Patients who are pregnant, have a history of prior radiation, or have significant medical conditions that may interfere with the study will not benefit from this trial.
Why it matters
Potential benefit: If successful, this approach could lead to improved skin graft uptake and reduced complications for patients undergoing reconstructive surgery after head and neck cancer treatment.
How similar studies have performed: Previous studies have shown that tumescence can significantly reduce blood loss in burn surgery, suggesting potential benefits in similar reconstructive contexts, though this specific application in head and neck cancer is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Sacramento, California
- UC Davis Health — Sacramento, California, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.