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Tumescence for Skin Graft Success in Head and Neck Cancer Surgery

Phase 3
Recruiting
Research Sponsored by University of California, Davis
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one month post-op
Awards & highlights
Pivotal Trial
No Placebo-Only Group

Summary

This trial will compare the use of tumescence to the current standard of care in order to determine if it has a meaningful effect on STSG uptake at the recipient site.

Who is the study for?
This trial is for adults over 18 with head and neck cancers who need skin grafting after surgery. They should expect to live at least 3 more months, be able to follow the study plan, and not have had radiation before. Pregnant or breastfeeding women, those with severe infections recently, or any significant health issues that could affect safety are excluded.
What is being tested?
The trial tests if tumescence improves skin graft attachment in head and neck cancer surgeries compared to standard care. Tumescence involves swelling the tissue with fluid to reduce blood loss and may enhance graft quality. Participants will be randomly assigned to receive either tumescence or the current standard method.
What are the potential side effects?
While specific side effects of tumescence aren't detailed here, common risks might include discomfort at the injection site, bleeding, infection risk increase due to prolonged wound healing if grafts fail, and potential allergic reactions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one month post-op
This trial's timeline: 3 weeks for screening, Varies for treatment, and one month post-op for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percentage of graft uptake
Secondary study objectives
Incidence of BMI Comorbidity
Incidence of Diabetes Comorbidity
Incidence of Peripheral Arterial Disease Comorbidity
+3 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Tumescence During STSG HarvestExperimental Treatment1 Intervention
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.
Group II: No InterventionActive Control1 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.

Find a Location

Who is running the clinical trial?

University of California, DavisLead Sponsor
943 Previous Clinical Trials
4,755,623 Total Patients Enrolled

Media Library

Tumescence During STSG Harvest Clinical Trial Eligibility Overview. Trial Name: NCT04967391 — Phase 3
Head and Neck Cancers Research Study Groups: Tumescence During STSG Harvest, No Intervention
Head and Neck Cancers Clinical Trial 2023: Tumescence During STSG Harvest Highlights & Side Effects. Trial Name: NCT04967391 — Phase 3
Tumescence During STSG Harvest 2023 Treatment Timeline for Medical Study. Trial Name: NCT04967391 — Phase 3
~1 spots leftby Dec 2024
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