Open AbdomenSHIELDNCT07835334
Synthetic Mesh for Prevention of HernIa After opEn Abdomen cLosure stuDy
A study testing Definitive Fascial Closure Without Prophylactic Mesh and Prophylactic Onlay Mesh Placement in people with Open Abdomen and Incisional Hernia, run by Hospital San Juan de Dios Tenerife.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Open Abdomen, Incisional Hernia, Definitive Fascial Closure
- What is being tested?
- Definitive Fascial Closure Without Prophylactic Mesh and Prophylactic Onlay Mesh Placement
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 1 Sep 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients older than 18 years.
- Patients managed with an open abdomen approach.
- Patients undergoing definitive fascial closure.
Who cannot join
- 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.)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Synthetic Mesh for Prevention of HernIa After opEn Abdomen cLosure stuDy (SHIELD Study)
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:
Read more
- 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.
Read the detailed description
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.
- Conditions
- Open Abdomen, Incisional Hernia, Definitive Fascial Closure, Emergency Abdominal Surgery, Prevention of Incisional Hernia Using Prophylactic Mesh
- Being tested
- Definitive Fascial Closure Without Prophylactic Mesh, Prophylactic Onlay Mesh Placement
- 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
- Medical subject headings
- Incisional Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Definitive Fascial Closure Without Prophylactic MeshProcedure or surgery
Patients will undergo definitive fascial closure following open abdomen management, without placement of prophylactic mesh.
Prophylactic Onlay Mesh PlacementDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Prophylactic Onlay Mesh Placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Incisional Hernia
- 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.
Measured: 12 months following definitive fascial closure.
Secondary outcomes (2)
Burst abdomen rate
To evaluate the occurrence of fascial dehiscence (burst abdomen) following definitive fascial closure.
Measured: 1 month after surgery
Surgical Site Occurrence
- evaluate the incidence of superficial, deep, or organ/space surgical site complications related to the surgical procedure.
Measured: 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Open AbdomenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital San Juan de Dios Tenerife
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julen Ramon Rodríguez, University Hospital of the Nuestra Señora de Candelaria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07835334
- Sponsor's protocol ID
- Pending
- Acronym
- SHIELD
- Status last verified
- Jul 2026
- First submitted
- 17 Sep 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.