Vascularised Sentinel Skin Flaps to Detect Rejection in Pancreas Transplantation

University of Oxford

Status and phase

Unknown

Phase 2

Phase 1

Conditions

Pancreas Transplant Rejection

Treatments

Other: Sentinel skin flap

Study type

Interventional

Funder types

Other

Identifiers

NCT03183258

15/SW/0333

Details and patient eligibility

About

This pilot study aims to validate the use of vascularised donor-derived sentinel skin flaps for diagnosing rejection in pancreas transplantation. The aim of the study is to investigate the use of sentinel skin flaps in clinical practice and assess whether rejection occurs concordantly or discordantly between the skin flap and the transplanted abdominal organs. If successful, sentinel skin may allow improved immune surveillance and thereby facilitate earlier treatment of rejection with subsequent improvements in allograft survival and patient morbidity.

Enrollment

20 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Recipient of a pancreas transplant (SPK or PTA)
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 ulna artery in either forearm
Recipient of an enterically drained PTA
Patient has received any investigational medical drug within 30 days of transplantation
Patient is not willing to return to Oxford 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.