An interventional study of Definitive Fascial Closure Without Prophylactic Mesh and Prophylactic Onlay Mesh Placement in Open Abdomen, Incisional Hernia and Definitive Fascial Closure, sponsored by Hospital San Juan de Dios Tenerife. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-22.
Sponsored by Hospital San Juan de Dios Tenerife · Not applicable, Interventional, and Prevention
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:
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:
Be randomly assigned to one of the two study groups:
This study will evaluate the impact of synthetic prophylactic onlay mesh placement during definitive fascial closure in patients managed with an open abdomen approach following emergency surgery.
This is a single-center randomized clinical trial with a 1:1 allocation to two treatment groups: definitive fascial closure with prophylactic mesh and definitive fascial closure without mesh. The study will include adult patients treated in the General Surgery Department of the Hospital Universitario Nuestra Señora de Candelaria who required open abdomen management and in whom definitive fascial closure can be achieved.
The primary outcome will be the incidence of incisional hernia during postoperative follow-up. Secondary outcomes will include the occurrence of evisceration and surgical site complications, including infection, seroma, hematoma, enteroatmospheric fistula, and the need for surgical reintervention.
Patients will undergo protocolized follow-up for at least 12 months after definitive fascial closure through outpatient general surgery visits, including physical examination and imaging studies when necessary.
The purpose of the study is to obtain preliminary evidence regarding the efficacy and safety of prophylactic mesh in this clinical setting, with the aim of optimizing open abdomen management and reducing the incidence of incisional hernia and other abdominal wall complications.
212 studies on the registry are indexed under Incisional Hernia; 58 are open to participants now.
This study's planned enrollment of 30 is below the median of 110 across 130 interventional studies indexed under Incisional Hernia.
Browse Incisional Hernia studies →Hospital San Juan de Dios Tenerife is the lead sponsor of 4 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
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
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
Patients will undergo definitive fascial closure following open abdomen management, without placement of prophylactic mesh.
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.
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.
Time frame: 12 months following definitive fascial closure.
Burst abdomen rate
To evaluate the occurrence of fascial dehiscence (burst abdomen) following definitive fascial closure.
Time frame: 1 month after surgery
Surgical Site Occurrence
o evaluate the incidence of superficial, deep, or organ/space surgical site complications related to the surgical procedure.
Time frame: 30 days after surgery
No study locations are listed for this record.
Plan to share: No — Individual Participant Data (IPD) will not be shared because this is a small single-center exploratory study with a limited sample size. All collected data will remain anonymized and confidential in accordance with applicable data protection regulations.
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Hospital San Juan de Dios Tenerife