search
Back to results

Tumescence in HNC Skin Graft Reconstruction

Primary Purpose

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

Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Tumescence During STSG Harvest
Sponsored by
University of California, Davis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Head and Neck Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • UC Davis HealthRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Tumescence During STSG Harvest

No Intervention

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
June 21, 2021
Last Updated
June 14, 2023
Sponsor
University of California, Davis
search

1. Study Identification

Unique Protocol Identification Number
NCT04967391
Brief Title
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

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Davis

4. Oversight

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
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer, Surgery--Complications, Graft Failure

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
saline vs saline with epinephrine
Masking
ParticipantInvestigator
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.
Allocation
Randomized
Enrollment
58 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tumescence During STSG Harvest
Arm Type
Experimental
Arm Description
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.
Arm Title
No Intervention
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Tumescence During STSG Harvest
Intervention Description
Tumescence injections performed prior to STSG harvest
Primary Outcome Measure Information:
Title
Percentage of graft uptake
Description
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
Time Frame
One Month Post-op
Secondary Outcome Measure Information:
Title
The Occurence of Graft Locations
Description
To determine whether the location of the graft (radial forearm v fibula) affects the graft take.
Time Frame
One Month Post-op
Title
Size of skin graft
Description
To determine whether the size of the recipient site defect affect graft take.
Time Frame
One Month Post-op
Title
Incidence of Smoking Status Comorbidity
Description
To evaluate if comorbidities including smoking status affect skin graft take.
Time Frame
One Month Post-op
Title
Incidence of Diabetes Comorbidity
Description
To evaluate if comorbidities including Diabetes affect skin graft take.
Time Frame
One Month Post-op
Title
Incidence of BMI Comorbidity
Description
To evaluate if comorbidities including BMI affect skin graft take.
Time Frame
One Month Post-op
Title
Incidence of Peripheral Arterial Disease Comorbidity
Description
To evaluate if comorbidities including Peripheral Arterial Disease affect skin graft take.
Time Frame
One Month Post-op

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria Patients must meet all of the following criteria to be eligible for study entry. 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. Exclusion Criteria Patients who meet any of the following criteria will be excluded from study entry. 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.
Facility Information:
Facility Name
UC Davis Health
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marianne Abouyared, MD
Phone
916-734-2704
Email
mabouyared@ucdavis.edu

12. IPD Sharing Statement

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

Learn more about this trial

Tumescence in HNC Skin Graft Reconstruction

We'll reach out to this number within 24 hrs