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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the optimal duration for keeping a cast and bolster on after a skin graft to enhance healing. It targets individuals who have undergone fibula or radial forearm free flap surgery, often required after facial cancer surgery or injury. Researchers aim to determine if extending the cast duration to 10-14 days, rather than the usual 5-7 days, improves healing and affects quality of life. Participants should be adults who have had these specific surgeries and skin grafts. As an unphased trial, this study provides participants the chance to contribute to significant research that could enhance post-surgical recovery for future patients.

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 prior data suggests that this cast and bolster placement duration is safe?

Research has shown that adjusting the duration of cast and bolster use can affect the success of skin grafts. One study found fewer issues such as fluid buildup, bleeding, and infections when specific methods were applied. The trial you might join examines the optimal duration for keeping the cast and bolster on to enhance healing.

The main risk is that the skin graft might not "take," meaning it doesn't attach well to the wound. Factors like bleeding, infection, or movement can cause this. However, applying pressure on the graft with a cast and bolster can aid in better healing.

Overall, the treatment appears safe, with studies suggesting that proper management can reduce complications. This information may help you understand the trial's focus on improving skin graft outcomes if you decide to participate. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the impact of extending cast and bolster placement duration to improve healing and reduce complications after skin graft surgeries, such as radial forearm and fibula free flaps. Typically, casts and bolsters are left on for 5 to 7 days, but this study investigates whether extending this duration to 10-14 days offers better protection and stability for the graft, potentially leading to better outcomes. By identifying the optimal duration for cast and bolster placement, this trial could refine post-surgical protocols, leading to fewer complications and improved recovery for patients undergoing these types of reconstructive surgeries.

What evidence suggests that this trial's treatments could be effective for skin graft complications?

This trial will compare different durations for cast and bolster placement. Research has shown that keeping the cast and bolster on longer may improve skin graft healing. One study found that leaving the bolster on for 14 days instead of 5 days reduced movement and helped skin grafts attach more securely to the wound. The pressure from the bolster enhances blood supply to the graft, which is crucial for healing. Extending the bolster duration may lead to fewer complications and better integration of the graft with the wound. Participants in this trial will be assigned to either the control group, with standard durations, or the experimental group, with extended durations. ^{2 5 6 7 8}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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 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]

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]

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 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]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7163783/

Association of Bolster Duration With Uptake Rates of Fibula ...

We hypothesized that maintaining the bolster for 14 days compared with 5 days would lead to decreased shearing and result in improved skin ...

2.

cdn.clinicaltrials.gov

cdn.clinicaltrials.gov/large-docs/67/NCT04648267/Prot_SAP_000.pdf

Factors Affecting Split Thickness Skin Graft Success Rates

The primary outcome will be to determine if having the bolster and cast on for 5-7 days versus 10-14 days will affect split thickness skin graft take rates.

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6956263/

Retrospective Study on the Clinical Superiority of ...

In this study, we introduce a new method using vacuum-assisted closure (VAC) with a silicon-based dressing as an alternative for skin graft fixation.

4.

gmr.scholasticahq.com

gmr.scholasticahq.com/article/7755-major-risk-factors-contributing-to-split-thickness-skin-graft-failure/attachment/20207.docx

20207.docx

These results indicate that NPWT after skin graft placement yields a greater success rate for split-thickness skin grafts than conventional bolster dressing.

5.

sciencedirect.com

sciencedirect.com/science/article/pii/S0741521414000962

Split-thickness skin grafting the high-risk diabetic foot

The average duration of follow-up was 12.0 ± 12.9 months. After STSG placement, 65 (69.1%) experienced complete graft incorporation and healing, and 18 (19.1%) ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7951281/

Retrospective evaluation of clinical outcomes in subjects ...

In assessing safety, there were fewer complications in graft failure (seroma, hematoma and infection) in the NPWT/ROCF group as compared to the CT group at 8·9 ...

7.

ncbi.nlm.nih.gov

ncbi.nlm.nih.gov/books/NBK532875/

Full-Thickness Skin Grafts - StatPearls - NCBI Bookshelf - NIH

The most significant risk is graft failure, which may result from hematoma, infection, or disruption of graft contact with the wound bed.

8.

gmr.scholasticahq.com

gmr.scholasticahq.com/article/7755-major-risk-factors-contributing-to-split-thickness-skin-graft-failure

Major Risk Factors Contributing to Split Thickness Skin Graft ...

These results indicate that NPWT after skin graft placement yields a greater success rate for split-thickness skin grafts than conventional bolster dressing.