Clinical trial NCT04967391: Tumescence in HNC Skin Graft Reconstruction
Official title: The Role Of Tumescence In Split Thickness Skin Grafting For Reconstruction Of Head And Neck Cancer Resection
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Head and Neck Cancer
Surgery--Complications
Graft Failure
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2021-07-19
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: saline vs saline with epinephrine
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility 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.

Primary outcomes:
measure: Percentage of graft uptake
timeFrame: One Month Post-op
Secondary outcomes:
measure: The Occurence of Graft Locations
timeFrame: One Month Post-op
measure: Size of skin graft
timeFrame: One Month Post-op
measure: Incidence of Smoking Status Comorbidity
timeFrame: One Month Post-op
measure: Incidence of Diabetes Comorbidity
timeFrame: One Month Post-op
measure: Incidence of BMI Comorbidity
timeFrame: One Month Post-op
measure: Incidence of Peripheral Arterial Disease Comorbidity
timeFrame: One Month Post-op
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: UC Davis Health
state: California
Study officials:
References: