Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Graft Failure | — | UNRESOLVED | — |
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Surgery--Complications | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Tumescence During STSG Harvest | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Tumescence During STSG Harvest
- description
- Prior to the split thickness skin graft (STSG) harvest, the tumescence technique will injection of 100-150 mL normal saline with 1:500,000 epinephrine injected into a deep dermal thigh tissue plane with 18-gauge spinal needle on a 60 mL syringe.
- interventionNames
- Procedure: Tumescence During STSG Harvest
- type
- NO_INTERVENTION
- label
- No Intervention
- description
- Patients randomized to "no tumescence" will have their free flap donor site reconstructed with a split thickness skin graft (STSG) harvested at 0.0175 inches using the dermatome to obtain a graft from the thigh.
Primary outcomes (1)
- measure
- Percentage of graft uptake
- timeFrame
- One Month Post-op
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available