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NOT YET RECRUITING
NCT07835334
NA

Synthetic Mesh for Prevention of HernIa After opEn Abdomen cLosure stuDy

Sponsor: Hospital San Juan de Dios Tenerife

View on ClinicalTrials.gov

Summary

The aim of this clinical trial is to evaluate whether placement of a synthetic prophylactic onlay mesh during definitive fascial closure can reduce the incidence of incisional hernia in adult patients managed with an open abdomen approach following emergency surgery. The main questions it aims to answer are: * Does prophylactic mesh placement reduce the incidence of incisional hernia compared with fascial closure without mesh? * Does prophylactic mesh placement influence the occurrence of postoperative complications such as evisceration or surgical site infection? Researchers will compare patients undergoing definitive fascial closure with prophylactic mesh placement to those undergoing fascial closure without mesh in order to determine whether the mesh decreases the incidence of incisional hernia and associated complications. Participants will: * Undergo standard open abdomen management followed by definitive fascial closure. * Be randomly assigned to one of the two study groups: * Definitive fascial closure without prophylactic mesh. * Definitive fascial closure with placement of a synthetic prophylactic onlay mesh. * Attend clinical follow-up visits in the general surgery outpatient clinic. * Undergo clinical evaluations at 1, 6, and 12 months after surgery, including physical examination and, if necessary, imaging studies to detect incisional hernia or postoperative complications.

Official title: Synthetic Mesh for Prevention of HernIa After opEn Abdomen cLosure stuDy (SHIELD Study)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2026-09-01

Completion Date

2027-09-01

Last Updated

2026-09-22

Healthy Volunteers

No

Interventions

PROCEDURE

Definitive Fascial Closure Without Prophylactic Mesh

Patients will undergo definitive fascial closure following open abdomen management, without placement of prophylactic mesh.

DEVICE

Prophylactic Onlay Mesh Placement

Following definitive fascial closure in patients undergoing open abdomen management, a medium-density, macroporous, non-absorbable synthetic mesh (Optilene®, B. Braun Surgical S.A.) will be placed in the onlay position as prophylactic reinforcement of the abdominal wall. The procedure will be performed during the definitive surgical intervention according to the standard practice of the General Surgery Department.