Tumescence for Skin Graft Success in Head and Neck Cancer Surgery

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: University of California, Davis

Disqualifiers: Pregnancy, Prior radiation, Severe infection, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 1 day

58 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether tumescence—a technique using fluid to create a firmer surface—can improve the success of skin grafts in patients undergoing surgery for head and neck cancer. Researchers aim to determine if this method enhances skin graft healing, reduces the need for additional medical visits, and lowers infection risk. Participants will either receive the tumescence treatment during surgery or follow the current standard method without it, allowing for a clear comparison. The trial seeks individuals scheduled for head and neck cancer surgery requiring skin grafting for repair. As a Phase 3 trial, this study represents the final step before potential FDA approval, offering participants a chance to contribute to a treatment that could soon become widely available.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

What prior data suggests that the tumescence technique is safe for skin graft procedures?

Research has shown that using tumescence in surgery is generally safe. In previous studies, no negative reactions occurred during its use in skin cancer reconstructive surgery. Another study found that tumescence reduced blood loss during skin grafting and was well-tolerated by patients. This technique involves injecting a mix of saltwater and a small amount of epinephrine, which narrows blood vessels, to firm the skin for easier grafting. It is commonly used in burn surgeries and is considered a standard practice due to its safety and effectiveness. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using the tumescence technique during skin graft procedures for head and neck cancer surgeries because it promises a smoother grafting process. Unlike traditional methods that rely solely on precise surgical technique, this approach involves injecting a solution of saline and epinephrine into the tissue before harvesting the skin graft. This pre-treatment helps to minimize bleeding and improve the skin's firmness, making it easier to handle and potentially increasing the success rate of the graft. By optimizing the grafting process, this technique could lead to better healing and outcomes for patients undergoing reconstructive surgeries.

What evidence suggests that tumescence is effective for improving skin graft success in head and neck cancer surgery?

Research shows that using a technique called tumescence during skin graft procedures helps reduce bleeding. In this trial, one group of participants will receive tumescence, which involves a mix of numbing medicine, adrenaline, and saltwater to prepare the skin for the graft. Studies have shown that tumescence is safe and enhances the process by reducing blood loss. It creates a firm surface for taking the skin, which can improve the quality and success of the graft. This method is already commonly used in burn surgeries and is known to be very effective. Another group in this trial will not receive tumescence, allowing for a comparison of outcomes. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

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.

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.

Life expectancy ≥ 3 months.

Exclusion Criteria

You have a medical condition that the investigator thinks will not be suitable for the study.

Pregnant or lactating women.

You have received radiation treatment in the past.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo split thickness skin graft (STSG) harvest with or without tumescence technique

1 day

1 visit (in-person)

Follow-up

Participants are monitored for graft uptake and comorbidities affecting graft take

4 weeks

1 visit (in-person), additional visits as needed

What Are the Treatments Tested in This Trial?

Interventions

• Tumescence During STSG Harvest

Trial Overview 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.

How Is the Trial Designed?

Group I: Tumescence During STSG Harvest Experimental Treatment 1 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 Intervention Active Control 1 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.

Who Is Running the Clinical Trial?

University of California, Davis

Lead Sponsor

Trials

958

Recruited

4,816,000+

Citations

1. withpower.com withpower.com/trial/phase-3-head-and-neck-neoplasms-10-2021-2d0a7

Tumescence for Skin Graft Success in Head and Neck ... Research shows that using a tumescent solution, which includes a local anesthetic, adrenaline, and saline, can reduce bleeding during skin graft procedures.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38394837/

Tumescent technique for split-thickness skin graft donor sites Conclusions: Level I evidence demonstrated tumescent techniques were safe and effective for STSG donor sites. Tumescent techniques reduced blood loss and ...

3. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2022-01563

Tumescence in Split Thickness Skin Grafting for ... This study compares two different methods of obtaining the skin graft used in reconstruction surgery – with or without a technique called tumescence.

4. clinicaltrial.be clinicaltrial.be/en/details/41613?per_page=20&recruiting=1&enrolling_by_invitation=1&active_not_recruiting=1&not_yet_recruiting=0&completed=0&only_recruiting=0&only_eligible=0

Tumescence in HNC Skin Graft Reconstruction - Clinical Tr... This is effectively accomplished with a split thickness skin graft harvested from the thigh, which generally results in excellent coverage of ...

5. ctv.veeva.com ctv.veeva.com/study/tumescence-in-hnc-skin-graft-reconstruction

Tumescence in HNC Skin Graft Reconstruction Our primary objective is to determine if the use of tumescence has a meaningful effect on STSG uptake at the recipient site.