Cast and Bolster Duration for Skin Graft Complications

Overseen By Liyang Tang

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Southern California

Disqualifiers: Inability to make decisions, others

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

Compensation: Varies

Number of Visits: 6

220 Participants Needed

Trial Summary

What is the purpose of this trial?

Fibula free flaps (FFF) and radial forearm free flaps (RFFF) are necessary to reconstruct parts of the face after cancer surgery, traumas, or debilitating infections. Oftentimes, after we take the flap from the arm or leg, there is a large skin defect that must be filled. A split thickness skin graft (STSG) usually from the thigh can be used to fill this defect. Split thickness skin grafts get their blood supply from the underlying tissue, Hence, pressure must be applied to the skin grafts to ensure that they "stick" to the underlying tissue and are properly perfused. A bolster and cast is placed onto the skin graft to apply pressure and to immobilize the skin graft to optimize healing. However, skin grafts still often do not take well. Thus, the objective of this study is to see if the duration of the cast and bolster over the skin graft has an effect on how well it integrates into the wound bed. The study will compare 2 groups: the standard of care 5-7 day cast group versus the experiment 10-14 day cast group. The hypothesis is that people with longer cast and bolster duration will have better healing rates. Surveys will also be administered to see if cast and bolster duration will affect quality of life and self-esteem.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Cast and bolster placement duration for skin graft complications?

Research suggests that using plaster casts after skin grafting can improve patient care by promoting faster wound closure and more complete graft take, especially in children with lower-extremity burns. Additionally, foam bolsters have been shown to be a reliable method for securing facial skin grafts, offering excellent results with low complication rates. ^{1 2 3 4 5}

Is the use of casts and bolsters for skin grafts generally safe?

The use of plaster casts after skin grafting in children has been shown to improve patient care with more rapid wound closure and fewer therapy treatments, indicating it is generally safe. Foam bolsters for securing facial skin grafts have also been found to produce excellent results with a low complication rate, suggesting they are safe as well. ^{1 2 4 5 6}

How does the cast and bolster placement duration treatment differ from other treatments for skin graft complications?

The cast and bolster placement duration treatment is unique because it involves using a cast to immobilize the area after a skin graft, which can lead to more rapid wound closure and more complete graft take, especially in children with lower-extremity burns. This method contrasts with traditional tie-over bolster dressings, which may not always improve success rates and can be unnecessary in some cases. ^{1 2 3 4 5}

Eligibility Criteria

This trial is for adults who've had a radial forearm or fibula free flap surgery with a skin graft from the thigh to cover the donor site. Participants must be able to make informed decisions and attend a follow-up appointment one month after surgery.

Inclusion Criteria

I had surgery using tissue from my forearm or leg to repair another area, with a skin graft over the donor site.

Exclusion Criteria

Patients who cannot make their one month post-operative appointment

I am unable to make informed decisions for myself.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Pre-surgery Evaluation

Pre-surgery evaluation visit where the study is discussed and consent forms are provided

1 day

1 visit (in-person)

Surgery and Immediate Post-operative Care

Participants undergo surgery and receive routine post-operative care. Randomization to cast and bolster duration occurs.

1 day

1 visit (in-person)

Post-operative Monitoring

Participants are monitored for cast and bolster duration, with removal occurring either before discharge or at the first post-operative visit.

5-14 days

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including surveys and photo assessments.

3 months

2 visits (in-person), 1 remote survey

Treatment Details

Interventions

• Cast and bolster placement duration
• Standard of care

Trial Overview The study tests if keeping a cast and bolster (which applies pressure) on the skin graft for longer periods (10-14 days) versus standard care (5-7 days) improves healing rates, quality of life, and self-esteem in patients.

Participant Groups

Group I: Experimental group Experimental Treatment 1 Intervention

Patients who have the cast and bolster on for 10-14 days

Group II: Control group Active Control 1 Intervention

Patients who have the cast and bolster on for standard 5 days after their radial forearm free flap and 7 days after their fibula free falp

Who Is Running the Clinical Trial?

University of Southern California

Lead Sponsor

Trials

956

Recruited

1,609,000+

Findings from Research

In a study of 71 patients with skin cancer on the foot, skin grafting was more successful in non-weight-bearing areas compared to weight-bearing areas, indicating that the location of the lesion significantly affects graft success.

Delayed reconstruction of skin grafts led to higher success rates than immediate reconstruction, especially for lesions in weight-bearing areas, suggesting that timing is crucial for optimal outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Retrospective evaluation of factors influencing successful skin grafting for patients with skin cancer of the foot. Goto, H., Yoshikawa, S., Mori, K., et al.[2022]

In a study involving 212 patients, the use of a polyurethane sponge dressing resulted in a higher success rate of 97.1% for skin grafts, compared to 89.6% with the traditional tie-over bolster dressing.

The polyurethane sponge dressing significantly reduced complications, with only 3 out of 106 patients experiencing issues, highlighting its efficacy as a superior alternative for graft fixation in challenging body areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Skin grafting: comparative evaluation of two dressing techniques in selected body areas. De Gado, F., Chiummariello, S., Monarca, C., et al.[2008]

In a study of 96 patients who underwent full thickness skin grafts for facial skin cancer reconstruction, complete graft take was achieved in 94 out of 96 patients without the use of tie-over bolster dressings, indicating that these dressings may not be necessary for successful healing.

The technique used not only resulted in high graft success rates but also offered benefits such as reduced operative time, lower costs, and less discomfort for patients, suggesting that tie-over bolsters could be considered an unnecessary step in most cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Are tie-over bolster dressings necessary for healing or success of full thickness skin graft reconstruction following facial skin cancer excision? Armstrong, D., Van Gijn, D., Newlands, C.[2022]

In a study of 36 children with burns below the knee, those who received plaster casts after skin grafting showed faster wound closure and more complete graft take compared to those who were not casted.

The use of plaster casts was associated with fewer therapy treatments and was found to be a cost-effective method for improving patient care in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The benefits of plaster casting for lower-extremity burns after grafting in children. Ricks, NR., Meagher, DP.[2019]

In a review of 60 cases of facial skin cancer reconstruction using full-thickness skin grafts, the use of foam as a bolster was found to be a simple and effective method, leading to consistently excellent results.

This technique demonstrated a low complication rate, highlighting its reliability and efficiency in securing skin grafts to recipient beds.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of foam bolsters for securing facial skin grafts. Caldwell, RK., Giles, WC., Davis, PT.[2006]

The report introduces a new bolstering technique that effectively supports skin grafts in the floor of the mouth, even when traditional anchorage points like teeth and alveolus are missing.

This innovative approach demonstrates potential for improving surgical outcomes in challenging cases where standard methods may not be applicable.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Securing intraoral skin grafts to the floor of the mouth: case report and technique desription. Kenny, EM., Egro, FM., Solari, MG.[2019]

References

1. England pubmed.ncbi.nlm.nih.gov

Retrospective evaluation of factors influencing successful skin grafting for patients with skin cancer of the foot. [2022]

2. Greece pubmed.ncbi.nlm.nih.gov

Skin grafting: comparative evaluation of two dressing techniques in selected body areas. [2008]

3. Scotland pubmed.ncbi.nlm.nih.gov

Are tie-over bolster dressings necessary for healing or success of full thickness skin graft reconstruction following facial skin cancer excision? [2022]

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

The benefits of plaster casting for lower-extremity burns after grafting in children. [2019]

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

Use of foam bolsters for securing facial skin grafts. [2006]

6. Czech Republic pubmed.ncbi.nlm.nih.gov

Securing intraoral skin grafts to the floor of the mouth: case report and technique desription. [2019]