Multi Center Observation of Sentinel Skin Graft for Detecting Acute Rejection After Renal Transplantation

ConditionsKidney Transplant Rejection Skin Graft

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18-60

SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University

About this trial

The purpose of this study was to explore the accuracy of sentinel skin grafts from the same donor source in diagnosing renal allograft rejection, and to provide new ideas and options for the later clinical diagnosis of renal allograft rejection. Further, try to provide timing guidance for early immunization intervention.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with end-stage renal disease undergoing renal transplantation;

18-60 years old;

Postoperative follow-up points are complete (visit the hospital every week in the first month after surgery, every two weeks in 2-3 months, every four to six months, and every three months in 7-12 months. Follow up at any time when skin rejection is observed. The follow-up time may be adjusted when the condition changes);

The participants had good compliance, volunteered to participate in the test and signed the informed consent form.

Disqualifiers

Untreated or disseminated malignant tumor;

Active period of infectious diseases;

Serious cardiovascular disease occurred recently;

Combined with other important organ failure;

Trial population

This study is an exploratory study. In the early stage, there is no relevant study on the accuracy of sentinel skin flap monitoring renal rejection, and there is a lack of corresponding sensitivity and specificity indicators. Considering that the incidence of acute rejection in the first year after transplantation is 15-30%, it is estimated that 20 cases will be included. Because the experimental data may be lost, or the participants may withdraw from the trial or lose the interview, the sample size will be increased by 20%, and finally 24 cases will be included in the trial.

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

Skin allotransplantation
Procedure/Surgery
Sentinel skin grafts from the same donor source will be carried on in the meantime of kidney transplantation for assisting to detect acute renal rejection.

Treatment groups

24 Participants

are divided into 1 treatment group

Group A: Kidney and skin transplataiton1 intervention

Trial outcomes