Tumescence in HNC Skin Graft Reconstruction

• ClinicalTrials.gov Identifier: NCT04967391
• Recruitment Status: Recruiting
• First Posted: July 19, 2021
• Last Update Posted: January 10, 2022
• Sponsor: University of California, Davis
• Information provided by (Responsible Party): University of California, Davis

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Head and Neck Cancer; Surgery--Complications; Graft Failure	Procedure: Tumescence During STSG Harvest	Phase 3

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 58 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Masking Description: Participants will be masked to the randomization group. Investigators that will be reviewing the graft images will also be masked to the randomization group.
• Primary Purpose: Supportive Care
• Official Title: The Role Of Tumescence In Split Thickness Skin Grafting For Reconstruction Of Head And Neck Cancer Resection
• Actual Study Start Date: September 1, 2021
• Estimated Primary Completion Date: August 1, 2023
• Estimated Study Completion Date: December 31, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Percentage of graft uptake [ Time Frame: One Month Post-op ]
   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

Secondary Outcome Measures :

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

Eligibility Criteria

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

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.

Contacts and Locations

Locations

United States, California

UC Davis Health; Recruiting

Sacramento, California, United States, 95817

Contact: Marianne Abouyared, MD 916-734-2704 mabouyared@ucdavis.edu

Sponsors and Collaborators

University of California, Davis

More Information

• Responsible Party: University of California, Davis
• ClinicalTrials.gov Identifier: NCT04967391
• Other Study ID Numbers: 1777948
• First Posted: July 19, 2021
• Last Update Posted: January 10, 2022
• Last Verified: December 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: IPD will not be shared with other researchers.

• 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

Additional relevant MeSH terms:

Head and Neck Neoplasms; Neoplasms by Site; Neoplasms