Definitive Fascial Closure Without Prophylactic Mesh
ProcedurePatients will undergo definitive fascial closure following open abdomen management, without placement of prophylactic mesh.
NCT Number: NCT07835334
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 12 months following definitive fascial closure.
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: 1 month after surgery
To evaluate the occurrence of fascial dehiscence (burst abdomen) following definitive fascial closure.
Time frame: 30 days after surgery
o evaluate the incidence of superficial, deep, or organ/space surgical site complications related to the surgical procedure.
Contact information is provided by the study sponsor or research team.
Hospital San Juan de Dios Tenerife
Other
Synthetic Mesh for Prevention of HernIa After opEn Abdomen cLosure stuDy (SHIELD Study)
Acronym: SHIELD
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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