Vascularised Sentinel Skin Flaps to Predict Rejection in Intestinal Transplantation

NCT06718400 | Withdrawn

• 1 other identifier: 21-882
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Conditions

Intestinal Transplant

Keywords

Transplant; Sentinel Skin Flap

Outcome Measures

Primary Outcomes (1)

• Correlation of histological rejection in the skin flap and the transplanted solid organ

  To establish if a sentinel skin flap acts as a marker of rejection of the transplanted organ.

  12 months

Study Arms (1)

Sentinel Skin Flap

EXPERIMENTAL

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

Procedure: Sentinel Skin Flap

Interventions

Sentinel Skin Flap PROCEDURE

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

Sentinel Skin Flap

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Officials

• Anil Vaidya, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

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

Study Record Dates

• First Submitted: May 9, 2022
• First Posted: December 5, 2024
• Study Start: October 1, 2023
• Primary Completion: October 1, 2023
• Study Completion: October 1, 2023
• Last Updated: December 5, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share