Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID04794582

Prevention of Incisional Hernia After Renal Transplantation Using ProGrip Mesh

Led by Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal · Updated on 2024-11-22

160

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

F

Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Lead Sponsor

M

Medtronic

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the effectiveness of mesh reinforcement in closing the abdominal incision after kidney transplantation to reduce the chance of developing incisional hernias within 2 years after surgery. Incisional hernias are defects or bulges at the surgical scar site that can cause complications and may require further surgery. This study focuses on kidney transplant patients who face higher hernia risks due to immunosuppressive treatments and other factors like obesity and female sex. The trial compares two methods of closing the surgical wound: one group receives a self-gripping polyester mesh called ProGrip placed above the muscle layer to reinforce the closure without additional stitches. The control group has the incision closed using a standard two-layer suture technique with long-lasting absorbable thread. Both groups have a small drain placed under the skin after surgery to remove fluids for a few days. Participants will be followed for 24 months after their transplant, with check-ups at 3, 6, 12, and 24 months. These visits include physical exams, lab tests, monitoring for side effects, and a CT scan at the end of the study to detect hernias. The study aims to measure how well the mesh prevents hernias and to assess the safety of this approach. A total of 160 adult first-time kidney transplant recipients will take part, with obesity being considered in how participants are assigned to groups.

CONDITIONS

Brief Title

Prevention of Incisional Hernia After Renal Transplantation

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Candidate for first kidney transplant
  • Age 18 years or older
Not Eligible

You will not qualify if you...

  • Patient receiving a second or successive renal transplant.

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - Hospital stay until post-transplant day 2 or 3

Participants undergo kidney transplantation surgery with either mesh reinforcement or standard closure, followed by immediate post-operative care including placement and removal of a subcutaneous drain.

1 surgical procedure and hospital stay with drain removal on day 2 or 3

Post-operative Follow-up

Duration - 24 months after surgery

Participants have clinical visits including physical examination, laboratory tests, and monitoring for adverse effects at 3, 6, 12, and 24 months after surgery. The final evaluation at 24 months includes a radiological examination (CT scan) to assess the presence of incisional hernia.

Clinical visits at 3, 6, 12, and 24 months including physical exams and tests; 1 radiological exam at 24 months

Trial Site Locations

Total: 1 location

1

Hospital Universitario Ramón y Cajal

Madrid, Spain, 28034

Actively Recruiting

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Research Team

G

GOMEZ

B

BURGOS

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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Published Research Related To This Trial

Prevention of incisional hernia after kidney transplantation: study protocol for a randomized controlled trial.

Victoria Gómez-Dos-Santos, José Antonio López-Plaza, José Manuel Molina-Villar...

https://pubmed.ncbi.nlm.nih.gov/37580782