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

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Tumescence During STSG Harvest for skin graft success in head and neck cancer surgery?

Research shows that using a tumescent solution, which includes a local anesthetic, adrenaline, and saline, can reduce bleeding during skin graft procedures. This method has been found to help control bleeding at the donor site and does not negatively affect healing, making it a potentially effective treatment for improving skin graft success. ^{1 2 3 4 5}

Is tumescent solution safe for use in humans?

Tumescent solution, used in various surgeries, has been shown to be safe with no adverse reactions reported in skin cancer reconstructive surgery and no negative effects on healing in skin graft procedures. ^{1 2 4 5 6}

How does the treatment Tumescence During STSG Harvest differ from other treatments for skin graft success in head and neck cancer surgery?

Tumescence involves injecting a solution containing a local anesthetic, adrenaline, and saline under the skin before harvesting a skin graft. This method is unique because it reduces bleeding at the donor site and provides pain relief, which can improve the overall success of the skin graft procedure. ^{1 4 5 7 8}

Eligibility Criteria

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.

Men and women ≥18 years of age.

Ability to adhere to the study visit schedule and other protocol requirements.

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

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

Treatment Details

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.

Participant Groups

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+

References

1. United States pubmed.ncbi.nlm.nih.gov

Clinical parameters of tumescent anesthesia in skin cancer reconstructive surgery. A review of 86 patients. [2008]

2. United States pubmed.ncbi.nlm.nih.gov

Bilevel tumescent anesthetic infiltration for hair transplantation. [2019]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Use of a topical mix of lidocaine and prilocaine during split-thickness skin graft harvest improves postoperative recovery-A prospective randomized controlled trial. [2022]

4. Japan pubmed.ncbi.nlm.nih.gov

Effect of Subcutaneous Adrenaline/Saline/Lidocaine Injection on Split-Thickness Skin Graft Donor Site Wound Healing. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Effect of subcutaneous epinephrine/saline/local anesthetic versus saline-only injection on split-thickness skin graft donor site perfusion, healing, and pain. [2018]

6. England pubmed.ncbi.nlm.nih.gov

Systematic literature review of topical local anaesthesia or analgesia to donor site wounds. [2022]

7. Japan pubmed.ncbi.nlm.nih.gov

Severe post-burn neck contracture release and skin graft harvest using tumescent local anaesthesia as the sole anesthetic technique. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

The Use of Tumescent Technique in Mastectomy and Related Complications: A Meta-Analysis. [2021]