Intestinal Transplant
Conditions
Keywords
Transplant, Sentinel Skin Flap
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
Interventions
PROCEDURESentinel Skin Flap
Willing participants who will be receiving an intestinal transplantation will receive a sentinel skin flap on their forearm from the same donor
Sponsors
The Cleveland Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
Willing participants who will be receiving an intestinal transplantation will receive a sentinel skin flap on their forearm from the same donor
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Outcome results
None listed