Vascularised Sentinel Skin Flaps to Predict Rejection in Intestinal Transplantation

NCT ID: NCT06718400

Last Updated: 2024-12-05

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-31
• Study Completion Date: 2023-10-31

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

Conditions

Intestinal Transplant

Keywords

Transplant; Sentinel Skin Flap

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Sentinel Skin Flap

Willing participants who will be receiving an intestinal transplantation will receive a sentinel skin flap on their forearm from the same donor

Group Type: EXPERIMENTAL

Sentinel Skin Flap

Intervention Type: PROCEDURE

Willing participants who will be receiving an intestinal transplantation will receive a sentinel skin flap on their forearm from the same donor

Interventions

Sentinel Skin Flap

Willing participants who will be receiving an intestinal transplantation will receive a sentinel skin flap on their forearm from the same donor

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Recipient of an intestinal transplant.
• Participant is willing and able to give informed consent for participation in the study
• Male or Female, aged 18 years or above

Exclusion Criteria

• Patient does not have a patent ulnar artery in either forearm or a negative Allen's test.
• Patient is not willing to return to the Institution for all clinical follow-up for 12 months
• Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the trial, or the participant's ability to participate in the study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Cleveland Clinic

OTHER

Sponsor Role: lead

Responsible Party

Anil Vaidya

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anil Vaidya, MD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Other Identifiers

21-882

Identifier Type: -

Identifier Source: org_study_id