Abdominal Wall Transplant for Abdominal Wall Defects

Overseen By Linda Cendales, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Disqualifiers: Malignancy, Pregnancy, Substance abuse, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

5 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this protocol is to determine the safety and efficacy of abdominal wall transplantation as a treatment for the reconstruction of abdominal wall defects. Abdominal wall transplantation may be performed alone or in combination with another transplant.

Do I need to stop my current medications for the trial?

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

What data supports the effectiveness of the treatment Abdominal Wall Transplant for Abdominal Wall Defects?

Abdominal wall vascularized composite allotransplantation (AW-VCA) has been successfully performed in 21 patients, providing immediate abdominal closure for those already receiving solid organ transplants. This technique is considered technically feasible for reconstructing large abdominal wall defects when traditional methods are not possible. ^{1 2 3 4 5}

Is abdominal wall transplantation generally safe for humans?

Abdominal wall transplantation has been performed in some patients, but it comes with risks. In one case, a patient experienced episodes of rejection and developed a brain infection due to the drugs used to prevent rejection. These drugs, called immunosuppressants, can weaken the immune system, making infections more likely. ^{1 2 3 4 5}

How is the abdominal wall transplant treatment different from other treatments for abdominal wall defects?

Abdominal wall transplant is unique because it involves transplanting a full-thickness section of the abdominal wall from a donor, which includes skin, muscle, and blood vessels, to reconstruct large defects that cannot be closed with traditional methods. This treatment is often used in conjunction with organ transplants and aims to restore both the form and function of the abdominal wall, which is not possible with simpler surgical repairs. ^{1 2 3 4 6}

Research Team

Kadiyala Ravindra, MD

Principal Investigator

Duke University

Linda Cendales, MD

Principal Investigator

Duke University

Eligibility Criteria

This trial is for adults aged 18-65 with severe abdominal wall defects, possibly needing an additional organ transplant. Candidates must be able to consent and meet criteria for a non-vascularized composite allograft at Duke. Exclusions include cancer history, pregnancy or potential pregnancy without agreed contraception use, anesthesia risks, and untreated substance abuse.

Inclusion Criteria

I am eligible for an organ transplant at Duke, including my abdominal wall.

I am willing and legally able to consent to participate.

Exclusion Criteria

You are currently using drugs or have a history of using drugs without getting help.

Pregnancy: Women who are of childbearing potential must have a negative serum pregnancy test within 48 hours of transplant and agree to use reliable contraception with two contraceptive methods for a minimum of 2 years following abdominal wall transplantation. Subjects seeking to become pregnant following 2 years will be made aware during the consent process that the effect of pregnancy on the transplanted abdominal wall and vice versa is unknown.

My cancer or past cancer prevents me from having a transplant.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Transplantation and Initial Treatment

Participants undergo abdominal wall transplantation, either alone or in combination with another organ transplant, and receive standard immunosuppression therapy

4-6 weeks

Follow-up

Participants are monitored for safety and effectiveness of the abdominal wall transplant to restore function of the defective abdominal wall

18 months

Treatment Details

Interventions

• Abdominal Wall Transplant
• Immunosuppressive Agents

Trial Overview The study is testing the safety and effectiveness of abdominal wall transplants either as a standalone procedure or alongside another solid organ transplant. The goal is to see how well this surgery repairs serious abdominal wall problems.

Participant Groups

Group I: Isolated Abdominal Wall Transplant Experimental Treatment 1 Intervention

Group II: Abdominal Wall with Solid Organ Transplant Experimental Treatment 1 Intervention

Abdominal Wall Transplant is already approved in European Union, United States for the following indications:

Approved in European Union as Abdominal Wall Transplantation for:

• Reconstruction of abdominal wall defects after intestinal transplantation
• Reconstruction of abdominal wall defects after multivisceral transplantation

Approved in United States as Abdominal Wall Transplantation for:

• Reconstruction of abdominal wall defects after intestinal transplantation
• Reconstruction of abdominal wall defects after multivisceral transplantation

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

Linda Cendales

Lead Sponsor

Trials

2

Recruited

60+

Linda Cendales, MD

Collaborator

Trials

1

Recruited

5+

Detlev Erdmann, M.D.

Collaborator

Trials

1

Recruited

5+

Kadiyala Ravindra, M.D.

Collaborator

Trials

1

Recruited

5+

Findings from Research

Abdominal wall vascularized composite allotransplantation (AW-VCA) has been shown to be technically feasible with an overall flap/graft survival rate of 88% and no reported mortality related to the transplant, based on a systematic review of 18 procedures performed in 17 patients.

The study highlights that while AW-VCA presents low morbidity and mortality, functional outcomes were not adequately reported, indicating a need for further research to assess the long-term benefits and applications of this technique.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current concepts and systematic review of vascularized composite allotransplantation of the abdominal wall. Berli, JU., Broyles, JM., Lough, D., et al.[2022]

Abdominal wall vascularized composite allotransplantation (AW-VCA) is a promising option for reconstructing the abdominal wall in patients who cannot undergo traditional closure methods, with various revascularization techniques reported in the literature.

Four distinct revascularization techniques were identified, including methods that reduce graft ischemia time and improve surgical outcomes, highlighting the importance of optimizing these techniques as the field of AW-VCA evolves.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surgical Techniques for Revascularization in Abdominal Wall Transplantation. Atia, A., Hollins, A., Shammas, R., et al.[2022]

This study successfully established a novel anatomical model for abdominal wall vascularized composite allotransplantation (AW-VCA) using fresh cadaver torsos, demonstrating the feasibility of preserving motor and sensory functions in abdominal wall reconstruction.

The mean size of the harvested abdominal wall graft was 615 cm², and the identification of thoracolumbar nerves suggests that this approach could allow for functional recovery, potentially improving outcomes in patients with large abdominal wall defects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Functional abdominal wall reconstruction using an innervated abdominal wall vascularized composite tissue allograft: a cadaveric study and review of the literature. Broyles, JM., Berli, J., Tuffaha, SH., et al.[2022]

Abdominal wall vascularized composite allotransplantation (AW-VCA) is a promising and safe reconstructive technique for patients with large abdominal wall defects, showing high flap survival rates and low complication rates across various surgical methods.

The use of iliofemoral cuff-based flaps in cadaveric studies ensures good tissue perfusion, while incorporating thoracolumbar nerves can enhance functionality and prevent muscle atrophy in AW-VCA, indicating a potential for improved patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Abdominal Wall Vascularized Composite Allotransplantation: A Scoping Review. Bustos, VP., Escandón, JM., Santamaría, E., et al.[2022]

The first synchronous child-to-adult abdominal wall-vascularized composite allotransplantation (AW-VCA) was successfully performed, demonstrating the feasibility of this complex surgical option for patients with severe abdominal wall reconstruction needs.

The patient experienced three episodes of rejection, which were managed with high-dose steroids and Thymoglobulin, but also developed a fungal brain abscess due to immunosuppression, highlighting the risks associated with such treatments and the need for improved immunosuppression strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Synchronous Abdominal Wall and Small-bowel Transplantation: A 1-year Follow-up. Atia, A., Hollins, A., Erdmann, RF., et al.[2020]

Abdominal wall transplantation is a viable option for patients undergoing intestinal transplants, with 15 procedures performed on 14 patients, demonstrating its feasibility when primary closure is not possible.

While there were some complications, including two graft losses due to vascular thrombosis and three episodes of rejection treatable with steroids, the majority of patients survived, indicating that this technique can be safely integrated into complex transplant surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Abdominal wall transplantation: surgical and immunologic aspects. Selvaggi, G., Levi, DM., Cipriani, R., et al.[2022]

References

1. Denmark pubmed.ncbi.nlm.nih.gov

Current concepts and systematic review of vascularized composite allotransplantation of the abdominal wall. [2022]

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

Surgical Techniques for Revascularization in Abdominal Wall Transplantation. [2022]

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

Functional abdominal wall reconstruction using an innervated abdominal wall vascularized composite tissue allograft: a cadaveric study and review of the literature. [2022]

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

Abdominal Wall Vascularized Composite Allotransplantation: A Scoping Review. [2022]

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

Synchronous Abdominal Wall and Small-bowel Transplantation: A 1-year Follow-up. [2020]

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

Abdominal wall transplantation: surgical and immunologic aspects. [2022]