Tumescence in HNC Skin Graft Reconstruction

The Role Of Tumescence In Split Thickness Skin Grafting For Reconstruction Of Head And Neck Cancer Resection

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.

Study Overview

• Status: Recruiting
• Conditions: Head and Neck Cancer; Surgery--Complications; Graft Failure
• Intervention / Treatment: Procedure: Tumescence During STSG Harvest

Detailed Description

Multimodal treatment for head and neck cancer often includes surgical resection. Large tumors leave behind large anatomical defects when resected, which require reconstruction to rehabilitate form and function after ablative surgery. Two commonly used reconstructive options in reconstructive surgery are the radial forearm free flap and the fibula free flap. These in turn leave cutaneous defects at the donor site which must be reconstructed to protect the underlying soft tissues, muscles, and tendons exposed as a result of their harvest. This is effectively accomplished with a split thickness skin graft harvested from the thigh, which generally results in excellent coverage of the free flap donor site and minimal skin graft donor site morbidity. 1-3 Using a free flap for reconstruction following surgical tumor ablation often leaves behind a donor site that cannot be closed primarily and at our institution these defects are reconstructed using split-thickness skin grafts (STSG) harvested from the thigh. This creates an additional wound that must be carefully monitored, as poor skin graft take or failure can result in exposed muscle or tendon at the donor site. While many of these wound-healing complications can be treated with simple dressings, this can create added stress, another site of potential infection, and delayed healing and return to function.1-3 Tumescence of the skin graft harvest site involves a deep dermal infiltration of normal saline with epinephrine to the thigh prior to skin graft harvest. This has been demonstrated to minimize intraoperative blood loss4-6 and is routinely utilized in burn surgery where extensive skin grafting is often required.

The effect of tumescence on skin graft quality and take has not been evaluated. Anecdotally, it is our impression that this procedure may yield a lower graft failure rate thereby decreasing post-operative extremity immobility, risk of infection and wound care requirements.2 In this study, the investigators plan to compare the quality and take of split thickness skin grafts harvested with and without tumescence. Our results will have important implications for how split thickness skin grafting is performed in head and neck reconstructive surgery.

• Study Type: Interventional
• Enrollment (Estimated): 58
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95817
      • Recruiting
      • UC Davis Health
      • Contact: Marianne Abouyared, MD; Phone Number: 916-734-2704; Email: mabouyared@ucdavis.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tumescence During STSG Harvest; 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; Tumescence injections performed prior to 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Occurence of Graft Locations	To determine whether the location of the graft (radial forearm v fibula) affects the graft take.	One Month Post-op
Size of skin graft	To determine whether the size of the recipient site defect affect graft take.	One Month Post-op
Incidence of Smoking Status Comorbidity	To evaluate if comorbidities including smoking status affect skin graft take.	One Month Post-op
Incidence of Diabetes Comorbidity	To evaluate if comorbidities including Diabetes affect skin graft take.	One Month Post-op
Incidence of BMI Comorbidity	To evaluate if comorbidities including BMI affect skin graft take.	One Month Post-op
Incidence of Peripheral Arterial Disease Comorbidity	To evaluate if comorbidities including Peripheral Arterial Disease affect skin graft take.	One Month Post-op

Collaborators and Investigators

• Sponsor: University of California, Davis

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2021
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: June 21, 2021
• First Submitted That Met QC Criteria: July 8, 2021
• First Posted (Actual): July 19, 2021

Study Record Updates

• Last Update Posted (Estimated): May 16, 2024
• Last Update Submitted That Met QC Criteria: May 14, 2024
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms
• Other Study ID Numbers: 1777948

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD will not be shared with other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes