This phase III trial compares two different surgical techniques for skin grafting for reconstruction after surgery for head and neck cancer. Reconstruction after surgery for head and neck cancer may involve large tissue defects which require free tissue transfer (flaps) from the wrist or leg. These in turn leave behind an area of missing skin over underlying muscle and tendons, which must be covered with additional skin from another area of the body. Doctors harvest a split-thickness or partial thickness skin graft from the thigh to transfer skin to these areas that need it. This study compares two different methods of obtaining the skin graft used in reconstruction surgery – with or without a technique called tumescence. Tumescence involves the injection of saline with a very small amount of epinephrine under the site of skin graft harvest to determine if this can improve healing outcomes of the skin graft.
Additional locations may be listed on ClinicalTrials.gov for NCT04967391.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVE:
I. To assess the use of tumescence during split-thickness skin grafts (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 National Institutes of Health [NIH]) at one month post-operatively.
SECONDARY OBJECTIVES:
I. To identify if the use of tumescence will affect the quality of skin graft harvest, with an excellent harvest defined as having no clinically relevant gaps on the initial pass with the dermatome, a fair harvest defined as requiring suture repair in order to be usable for reconstruction, and a poor harvest having defects requiring harvest of a second skin graft.
II. To determine whether the location of the graft (radial forearm versus [v] fibula) affect the graft take.
III. To determine whether the size of the recipient site defect affect graft take.
IV. To evaluate if comorbidities including smoking status, diabetes, body mass index (BMI), and peripheral arterial disease affect skin graft take.
V. To evaluate if comorbidities including smoking status, diabetes, BMI, and peripheral arterial disease affect the quality of skin graft by the measures above.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: Patients undergo head and neck surgery followed by reconstructive surgery per standard of care.
GROUP II: Patients undergo head and neck surgery followed by reconstructive surgery per standard of care. Patients also receive normal saline and epinephrine injected into a deep dermal thigh tissue plane.
After completion of study treatment, patients are followed up at 1 week and 1 month.
Trial PhasePhase III
Trial Typesupportive care
Lead OrganizationUniversity of California Davis Comprehensive Cancer Center
Principal InvestigatorMarianne Abouyared
