Cytokine response after abdominal wall reconstruction
Pilot Study of Systemic Inflammatory and Transcriptomic Responses in Patients Undergoing Open Retromuscular Ventral Hernia Repair
The study will test whether high-tension closure during open ventral hernia repair causes stronger cytokine and physiologic responses than low-tension repairs or healthy controls in adults.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 25 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Northwestern University Academic / other |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT07422584 on ClinicalTrials.gov |
What this trial studies
This is a prospective, observational translational study of adults undergoing open retromuscular ventral hernia repair with perioperative biologic and physiologic sampling. The protocol combines serial cytokine profiling, direct intra-abdominal pressure measurement, and detailed clinical outcome tracking to compare surgeon-determined high-tension closures, low-tension closures, and healthy control volunteers. Planned cohorts include about 10 high-tension AWR patients, 10 low-tension AWR patients, and 5 healthy controls, and fascial closure tension will not be changed for research purposes. The goal is to link biologic signaling and intra-abdominal pressure changes to postoperative organ dysfunction and ICU needs.
Who should consider this trial
Good fit: Ideal participants are adults (18+) able to consent who are scheduled for elective open retromuscular ventral hernia repair, along with healthy adult volunteers without inflammatory or autoimmune disease for control sampling.
Not a fit: Patients undergoing emergent surgery, those on chronic immunosuppression or systemic steroids, pregnant individuals, those with active infection, recent abdominal surgery, or end-stage organ failure are excluded and would not benefit from participation.
Why it matters
Potential benefit: If successful, the results could help guide operative planning and perioperative care to reduce respiratory and renal complications after complex ventral hernia repair.
How similar studies have performed: Trauma and critical care studies have linked cytokine activation to organ dysfunction, but applying perioperative cytokine profiling to high-tension abdominal wall closure is largely novel and has limited prior data.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Surgical Participants * Adults aged 18 years or older * Scheduled to undergo open retromuscular ventral hernia repair * Able to provide written informed consent Healthy Control Participants * Adults aged 18 years or older * No known inflammatory, autoimmune, or immunologic disease * Able to provide written informed consent Exclusion Criteria: * Emergent or urgent cases * Pregnancy * Chronic systemic steroid use or immunosuppressive therapy * Active infection at the time of enrollment * Known autoimmune or inflammatory disease * End-stage organ failure * Abdominal surgery within the preceding 60 days
Where this trial is running
Chicago, Illinois
- Northwestern Memorial Hospital — Chicago, Illinois, United States (Recruiting)
Study contacts
- Study coordinator: Megan Melland-Smith, MD
- Email: megan.mellandsmith@nm.org
- Phone: 312-907-1414
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.