NCT07422584 Cytokine Response to Abdominal Wall Reconstruction
| NCT ID | NCT07422584 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Northwestern University |
| Condition | Incisional Ventral Hernia |
| Study Type | OBSERVATIONAL |
| Enrollment | 25 participants |
| Start Date | 2026-02-03 |
| Primary Completion | 2027-02-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 25 participants in total. It began in 2026-02-03 with a primary completion date of 2027-02-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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
Contact & Investigator
Michael Rosen, MD
STUDY DIRECTOR
Northwestern University
Frequently Asked Questions
Who can join the NCT07422584 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Incisional Ventral Hernia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07422584 currently recruiting?
Yes, NCT07422584 is actively recruiting participants. Contact the research team at megan.mellandsmith@nm.org for enrollment information.
Where is the NCT07422584 trial being conducted?
This trial is being conducted at Chicago, United States.
Who is sponsoring the NCT07422584 clinical trial?
NCT07422584 is sponsored by Northwestern University. The principal investigator is Michael Rosen, MD at Northwestern University. The trial plans to enroll 25 participants.