Skin Graft vs. Hatchet Flap for Donor Site Closure

Overseen By Tayo Steininger

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of British Columbia

Disqualifiers: Metastatic disease, Hand conditions, others

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

Compensation: Varies

Number of Visits: 3

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two methods for closing the donor site after using the radial forearm free flap in head and neck reconstruction. The researchers aim to determine if a split-thickness skin graft (taking a thin layer of skin from the thigh) improves aesthetic and functional outcomes more than the hatchet flap (a local flap within the forearm). Candidates for this trial include those with an oral cavity disease requiring this specific type of reconstruction surgery. As an unphased trial, it offers participants the chance to contribute to valuable research that may enhance surgical outcomes for future patients.

Do I have to stop taking my current medications for the trial?

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

What prior data suggests that these closure techniques are safe for donor site closure?

Research has shown that both the hatchet flap and split-thickness skin graft (STSG) methods for closing donor sites in radial forearm free flap (RFFF) surgeries are generally well-received by patients.

For the hatchet flap method, studies found a high success rate, with 93.3% of the flaps surviving and 28 out of 30 donor sites healing without problems. Patients typically tolerate this method well, and it often results in a good appearance.

The STSG method also provides good results. Research indicates that patients with STSG closures experience less disruption in daily activities, express greater satisfaction, and have better-looking scars compared to those with the hatchet flap method.

Both methods are considered safe based on these findings, each offering distinct advantages in terms of healing and patient satisfaction. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it compares two surgical techniques for closing forearm donor sites after a radial forearm free flap procedure: the hatchet flap method and the split-thickness skin graft (STSG). Unlike traditional closure methods, the hatchet flap technique might offer a more robust closure with potentially better cosmetic outcomes, as it uses adjacent skin flaps to cover the donor site. On the other hand, the STSG is a commonly used method that involves grafting skin from the thigh, which might lead to quicker healing at the donor site itself. This trial seeks to determine which technique provides better healing, aesthetic results, and patient satisfaction, which could improve recovery and outcomes for patients undergoing these procedures.

What evidence suggests that this trial's treatments could be effective for donor site closure?

This trial will compare two methods for closing the radial forearm donor site: the hatchet flap technique and the split-thickness skin graft (STSG). Research has shown that the hatchet flap technique is generally well-received by patients and results in good cosmetic outcomes. One study found that 93.3% of these procedures were successful, with most donor sites healing well without major issues. Although minor wound problems occurred in 42% of cases, the long-term appearance and function remained positive.

For participants in the STSG arm of this trial, studies indicate that this method provides good cosmetic results, similar to the hatchet flap. The STSG method carries a lower risk of graft failure compared to full-thickness skin grafts. Both techniques aim to improve the appearance and function of the donor site, with STSG also effectively preventing issues like tendon exposure. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for adults over 18 needing forearm flap reconstruction due to oral cavity diseases, who can handle surgery and fill out questionnaires in English. It's not for those with serious illnesses like metastatic disease, hand usage issues from conditions or scars, or women who are pregnant or breastfeeding.

Inclusion Criteria

I need surgery to rebuild my mouth area using tissue from my arm.

Exclusion Criteria

I cannot or do not want to fill out post-surgery forms in English.

Pregnant or lactating women

I have serious health issues that prevent me from having surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery and Initial Treatment

Participants undergo surgery for radial forearm free flap (RFFF) and donor site closure using either STSG or hatchet flap technique

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness, including aesthetic and functional outcomes, with follow-up visits and questionnaires

6 months

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Hatchet Flap
• Split-Thickness Skin Graft

Trial Overview The study compares two methods of healing the arm after a piece of it is used to reconstruct parts of the mouth affected by cancer or other diseases. One method uses skin from the thigh (STSG), while the other rearranges local tissue (hatchet flap).

How Is the Trial Designed?

Group I: STSG arm Active Control 1 Intervention

Patient demographics will be recorded during the enrollment visit. During the participant's surgery in which the radial forearm free flap (RFFF) has been used, surgeons will perform a split-thickness thigh graft to close the forearm donor site. A photograph will be taken of the participants' forearm upon the removal of the dressing and splint. On each of the two follow-up clinic visits, another photo will be taken of the forearm scar and patient-reported outcome questionnaires will be provided for completion.

Group II: Hatchet flap arm Active Control 1 Intervention

Patient demographics will be recorded during the enrollment visit. The hatchet flap closure of the forearm donor site will be performed following the RFFF's usage. A photograph will be taken of the participants' forearm upon the removal of the dressing and splint. On each of the two follow-up clinic visits, another photo will be taken of the forearm scar and patient-reported outcome questionnaires will be provided for completion.

Who Is Running the Clinical Trial?

University of British Columbia

Lead Sponsor

Trials

1,506

Recruited

2,528,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/22395046/

Closure of the radial forearm donor site using a local ... Conclusions: We recommend this technique of primary closure of the RFFF donor site: it is well tolerated by the patient, with good cosmesis and is associated ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38785176/

Outcomes of Radial Forearm Free Flap Closure With Split- ... This study compares patient-reported functional and aesthetic outcomes of split-thickness skin graft (STSG) versus hatchet flap closure of radial forearm free ...

3. journals.lww.com journals.lww.com/jhns/fulltext/2022/10010/a_technique_for_primary_closure_of_the_free_radial.12.aspx

A Technique for Primary Closure of the Free Radial Artery... Apart from minor wound complications in 42% of patients, they reported excellent long-term result of these patients in terms of function and cosmesis.

4. sciencedirect.com sciencedirect.com/science/article/pii/S1368837524004020

Innovative use of radial artery retrograde forearm flap for ... Flap survival was 93.3 %. The donor site defect in 28 out of 30 patients healed primarily. All donor sites were directly closed without complications such as ...

5. researchgate.net researchgate.net/publication/221681970_Closure_of_the_Radial_Forearm_Donor_Site_Using_a_Local_Hatchet_Flap_Analysis_of_45_Consecutive_Cases

Closure of the Radial Forearm Donor Site Using a Local ... We report our experience with primary closure using a local hatchet flap. Methods: In all, 45 consecutive patients who underwent RFFF ...

6. wjso.biomedcentral.com wjso.biomedcentral.com/articles/10.1186/s12957-023-02989-9

Novel V-shaped kiss flap harvest technique for the forearm ... This work introduces and evaluates the effectiveness and safety of a new technique for closing RFF donor-site defects based on a V-shaped kiss radial forearm ...