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Forearm skin flap for monitoring of acute transplant rejection in children and adolescents

Safety, feasibility, and acceptability of liver & small bowel transplant using a vascularised composite skin flap (sentinel flap) for monitoring of acute rejection in children and adolescents

Status
Withdrawn
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12621001663842
Enrollment
5
Registered
2021-12-03
Start date
2023-01-01
Completion date
2023-12-31
Last updated
2022-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

In this study, patients receiving a liver or bowel transplant will also receive a transplant of skin. The study will assess whether it is safe to transplant skin with a liver or bowel transplant by recording all adverse outcomes and assessing the survival of the skin transplant at regular intervals. It is hypothesised that it is safe to transplant skin. Future studies will assess whether the skin transplant can alert doctors to rejection occurring in the liver or bowel transplant.

Interventions

At the same time as receiving their bowel or liver transplant, study participants will receive a transplant of skin from the same donor as their solid organ. This intervention is performed surgically and requires standard surgical techniques performed in a standard operating theatre. Surgery requires retrieval of a skin flap from the organ donor followed by transplantation of the skin flap into the recipient. Both surgeries are performed by members of the Plastic & Maxillofacial Surgery depar

At the same time as receiving their bowel or liver transplant, study participants will receive a transplant of skin from the same donor as their solid organ. This intervention is performed surgically and requires standard surgical techniques performed in a standard operating theatre. Surgery requires retrieval of a skin flap from the organ donor followed by transplantation of the skin flap into the recipient. Both surgeries are performed by members of the Plastic & Maxillofacial Surgery department of the Royal Children's Hospital, Melbourne or suitably trained delegated representatives and will only be performed once. Donor and recipient surgery are conducted alongside surgery to perform solid organ transplantation. Additional anaesthetic is therefore not required. No additional investigations or interventions are required prior to surgery. Surgery to retrieve the skin flap from the donor takes approximately 45 minutes and will occur simultaneously with the solid organ donation (which takes approximately 4-5 hours). Skin will be elevated from the volar forearm along with its artery and vein. The is a standard procedure (called a radial forearm flap) regularly performed by plastic surgeons. The radial forearm flap will be divided from its blood supply at the same time as the liver or small bowel is removed. The skin will then be stored in a damp gauze, inside a water-proof bag, and placed on ice along with the bowel or liver for transport. The skin and organ are transported to the theatre suite of The Royal Children's Hospital, Melbourne where surgery to perform the transplant will be undertaken. The surgery to transplant the liver or small bowel usually takes 6 hours. The radial forearm flap will be joined to an artery and vein in the patient's forearm whilst the liver or small bowel is being transplanted. This procedure will take approximately 90 minutes but may not increase total operative time if performed concurrently. Postoperative care is delivered in accordance with standards for the solid organ transplantation. Postoperative medication, length of stay, and level of care varies and is determined by the type of solid organ transplant and the underlying cause of organ failure. The sentinel flap will not require any change to routine postoperative care other than clinical assessment by trained nursing staff every hour for 24 hours, then 4 hourly thereafter until discharge.

Sponsors

The Royal Children's Hospital, Melbourne
Lead SponsorHospital

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Diagnosis
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
No minimum to 18 Years
Healthy volunteers
No

Inclusion criteria

Each participant must meet all the following criteria to be enrolled in this trial: - Is 18 years of age or younger at the time of enrolment - Requires organ replacement therapy / organ support to the degree that prior specialist assessment has determined the need for liver, bowel, or multivisceral transplantation. - Has provided signed and dated consent through a legally acceptable representative, obtained outside of this study, to proceed with the recommended solid organ transplant (SOT). - Have a legally acceptable representative capable of understanding the informed consent document and provide consent to this study on the participant’s behalf.

Exclusion criteria

Patients meeting any of the following criteria will be excluded from the trial: - Donor or recipient intraoperative physiologic instability Relative contraindications to be considered on an individual basis by the trial management group at the point of enrolment. - Presence of donor specific antigen (DSA) exceeding a mean fluorescence index of 5000 - Planned ABO mismatched transplantation - Other high risk immunologic features identified by the study group

Outcome results

None listed

Source: ANZCTR · Data processed: Sep 4, 2026