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Simple injection may boost skin graft success in head and neck cancer patients

NCT ID NCT04967391

Symptom relief Sponsor: University of California, Davis Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 3 trial tests whether injecting a fluid (tumescence) before harvesting a skin graft helps the graft heal better after head and neck cancer surgery. About 58 adults having reconstructive surgery will be randomly assigned to receive tumescence or standard care. The main goal is to see if the technique improves graft take and reduces complications like infection or extra clinic visits.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
tumescence (fluid injection)
What this could lead to
If it works, this technique could improve skin graft healing, reduce infections, and cut down on extra clinic visits after head and neck cancer surgery.
What could go wrong
This is a small, single-center trial (58 people) testing a technique already standard in burn care. Results may not apply to all patients or settings.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 58 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2021

Expected to finish

Aug 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

head and neck cancer Head and Neck Neoplasms

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Graft failure Head and neck cancer Surgery--complications

Contacts and locations

Locations

  • UC Davis Health

    Sacramento, California, 95817, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.