Tumescence in HNC Skin Graft Reconstruction

NCT04967391 | Active Not Recruiting Phase 3

• 1 other identifier: 1777948
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Surgery--Complications; Graft Failure; Head and Neck Cancer

Outcome Measures

Primary Outcomes (1)

• Percentage of graft uptake

  To assess the use of tumescence during STSG harvest affect graft take at the recipient site as measured by percentage of graft uptake as measured using ImageJ (open source software available from NIH) at one month post-operatively

  One Month Post-op

Secondary Outcomes (6)

• The Occurence of Graft Locations

  One Month Post-op

• Size of skin graft

  One Month Post-op

• Incidence of Smoking Status Comorbidity

  One Month Post-op

• Incidence of Diabetes Comorbidity

  One Month Post-op

• Incidence of BMI Comorbidity

  One Month Post-op

Study Arms (2)

Tumescence During STSG Harvest

EXPERIMENTAL

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.

Procedure: Tumescence During STSG Harvest

No Intervention

NO INTERVENTION

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.

Interventions

Tumescence During STSG Harvest PROCEDURE

Tumescence injections performed prior to STSG harvest

Tumescence During STSG Harvest

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

UC Davis Health

Sacramento, California, 95817, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Participants will be masked to the randomization group. Investigators that will be reviewing the graft images will also be masked to the randomization group.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: saline vs saline with epinephrine

Study Record Dates

• First Submitted: June 21, 2021
• First Posted: July 19, 2021
• Study Start: September 1, 2021
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): August 30, 2026
• Last Updated: February 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)