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Completed
NCT07422584
Cytokine Response to Abdominal Wall Reconstruction
Conditions: Incisional Ventral Hernia
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: Yes
Enrollment: 25
Sponsor: Northwestern University
Location: Northwestern Memorial Hospital Chicago Illinois
Summary
This is a prospective, observational translational study of patients undergoing major abdominal wall reconstruction with primary fascial closure. The project integrates perioperative cytokine profiling, direct measurement of intra-abdominal pressure, and detailed clinical outcomes to define the biologic and physiologic consequences of high-tension closure.
The study includes three cohorts: 1) Healthy controls (N=5), 2) High-tension fascial closure AWR patients (N=10), 3) Low-tension fascial closure AWR patients (N=10). Fascial closure tension will not be altered for the purpose of the study and will be determined by the operating surgeon as part of routine clinical decision-making.
Eligibility 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
Source: ClinicalTrials.gov (NCT07422584). StuddyBuddy aggregates publicly available trial information.