Synthetic Mesh for Prevention of HernIa After opEn Abdomen cLosure stuDy

NCT07835334 | Not Yet Recruiting

• 1 other identifier: Pending
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Open Abdomen; Incisional Hernia; Definitive Fascial Closure; Emergency Abdominal Surgery; Prevention of Incisional Hernia Using Prophylactic Mesh

Keywords

Open abdomen; Incisional hernia; Prophylactic mesh; Definitive fascial closure; Emergency surgery; Negative pressure wound therapy; NPWT; Damage control surgery; Abdominal wall; Onlay mesh; Surgical complications; Emergency abdominal surgery

Outcome Measures

Primary Outcomes (1)

• Incidence of Incisional Hernia

  o evaluate the occurrence of incisional hernia following definitive fascial closure in patients undergoing open abdomen management, comparing patients who receive prophylactic onlay mesh reinforcement with those who do not receive prophylactic mesh.

  12 months following definitive fascial closure.

Secondary Outcomes (2)

• Burst abdomen rate

  1 month after surgery

• Surgical Site Occurrence

  30 days after surgery

Study Arms (2)

Definitive Fascial Closure Without Prophylactic Mesh

OTHER

Patients will undergo definitive fascial closure following open abdomen management, without placement of prophylactic mesh. Perioperative management and clinical follow-up will be conducted according to the standard practice of the department.

Procedure: Definitive Fascial Closure Without Prophylactic Mesh

Definitive Fascial Closure With Prophylactic Onlay Mesh

EXPERIMENTAL

Patients will undergo definitive fascial closure following open abdomen management, with placement of a synthetic, macroporous, non-absorbable prophylactic mesh (Optilene®, B. Braun Surgical S.A.) in the onlay position.

Device: Prophylactic Onlay Mesh Placement

Interventions

Definitive Fascial Closure Without Prophylactic Mesh PROCEDURE

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

Definitive Fascial Closure Without Prophylactic Mesh

Prophylactic Onlay Mesh Placement DEVICE

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.

Definitive Fascial Closure With Prophylactic Onlay Mesh

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients older than 18 years.
• Patients managed with an open abdomen approach.
• Patients undergoing definitive fascial closure.

You may not qualify if:

• Patients in whom definitive fascial closure cannot be achieved.
• Inability to complete clinical follow-up or high likelihood of loss to follow-up (e.g., residence outside the catchment area, lack of outpatient follow-up, etc.)

Sponsors & Collaborators

• Hospital San Juan de Dios Tenerife: lead

MeSH Terms

Conditions

Incisional Hernia

Condition Hierarchy (Ancestors)

Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes

Central Study Contacts

Julen Julen Ramón Rodríguez

CONTACT

34672255215; julentxu_92@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No masking will be applied in this study. Both the surgeons and the investigators will be aware of the participants' group allocation due to the surgical nature of the procedure and the need to document the intraoperative management performed.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, General Surgery

Model Details: Participants will be randomly assigned in a 1:1 ratio to one of two parallel intervention groups: definitive fascial closure without prophylactic mesh placement or definitive fascial closure with placement of a synthetic prophylactic onlay mesh. Clinical follow-up will be conducted for at least 12 months after surgery to evaluate the incidence of incisional hernia and associated postoperative complications.

Study Record Dates

• First Submitted: September 17, 2026
• First Posted: September 22, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: September 22, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share