Vascularised Sentinel Skin Flaps to Predict Rejection in Intestinal Transplantation

Not Applicable

Withdrawn

• Conditions: Intestinal Transplant

• Registration Number: NCT06718400
• Lead Sponsor: The Cleveland Clinic

Brief Summary

This pilot study aims to validate the use of vascularised donor-derived sentinel skin flaps for diagnosing and monitoring rejection in intestinal transplantation

Detailed Description

Intestinal transplantation is the current treatment option for patients with irreversible intestinal failure that has not responded to other methods of treatment. Whilst the majority of patients that have an intestinal transplant will obtain good graft function over many years, some patients suffer from reduced function of their new intestine following transplantation that can progress to the transplant failing completely.

Acute rejection may be the most common cause of transplant failure. Currently, there is not an effective way of monitoring the intestine that can detect rejection before irreversible damage occurs. If there is a more sensitive way of continuously monitoring the intestine transplant for rejection then issues could be earlier detected and early treatment could prevent permanent damage to the transplant.

The reason for this study is to assess a new technique that has been developed to detect early rejection in intestinal transplantation. The name of this technique is called a 'sentinel skin flap' and involves transplanting a patch of forearm skin from the donor at the same time as the intestine

Study Timeline

• Study First Submitted: 2022-05-09
• Study Start: 2023-10
• Primary Completion: 2023-10
• Study Completion: 2023-10
• Status Verified: 2024-12
• Study First Submitted QC: 2024-12-04
• Last Update Submitted: 2024-12-04
• Study First Posted: 2024-12-05
• Last Update Posted: 2024-12-05

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Correlation of histological rejection in the skin flap and the transplanted solid organ	12 months	To establish if a sentinel skin flap acts as a marker of rejection of the transplanted organ.