Prevention of Incisional Hernia After Renal Transplantation Using ProGrip Mesh
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
Randomized clinical trial to determine the efficacy of mesh reinforcement in laparotomy closure in renal transplantation as measured by reduction in the incidence of incisional hernia at 2 years post-transplantation.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Candidate for first kidney transplant
Locations
Other Locations
Spain
Hospital Universitario Ramón y Cajal
RECRUITING
Madrid
Contact Information
Primary
GOMEZ
vgomezd69@gmail.com
+34670795972
Backup
BURGOS
burgosrevillajavier@gmail.com
+34639155661
Time Frame
Start Date: 2022-08-31
Estimated Completion Date: 2026-12
Participants
Target number of participants: 160
Treatments
Active_comparator: ProGrip® Mesh reinforcement
Once the closure has been completed in 2 muscle-aponeurotic planes with continuous synthetic suture (Monomax® USP 0), the closure will be completed by placing the ProGrip® macroporous polypropylene monofilament mesh in supra-aponeurotic position using the surface with the polylactic acid microgrips, which act as Velcro, in direct contact with the superficial aponeurotic plane constituted by the aponeuroses of the greater oblique muscle and the crescentic line of the anterior rectus abdominis muscle. The polylactic acid microgrips provide immediate fixation, making additional fixation with stitches unnecessary, which makes the technique very easy to use and systematize among the different surgeons of the transplant team. The procedure is completed with the placement of a low caliber round Jackson-Pratt subcutaneous drain (10F) connected to a vacuum system that will be removed on post-transplant day 2 or 3
No_intervention: Monomax® USP 0 2 planes closure
The control group will proceed according to standard clinical practice with closure using the technique in 2 muscle-aponeurotic planes with very long-term (3 months) absorbable synthetic continuous suture of poly(4-hydroxybutyrate), monofilament, elastic (Monomax® USP 0) according to the small-bites technique. In order to achieve masking of the participating subject, a small-bore (10F) Jackson-Pratt drain connected to a vacuum system will be placed in the subcutaneous space at the end of the procedure in a manner similar to the intervention group. In both treatment groups, the subcutaneous drain will be removed on post-transplant day 2 or 3.
Related Therapeutic Areas
Sponsors
Collaborators: Medtronic
Leads: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal