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Pilot Study of Systemic Inflammatory and Transcriptomic Responses in Patients Undergoing Open Retromuscular Ventral Hernia Repair

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

⁃ 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

Locations
United States
Illinois
Northwestern Memorial Hospital
RECRUITING
Chicago
Contact Information
Primary
Megan Melland-Smith, MD
megan.mellandsmith@nm.org
312-907-1414
Backup
Nancy Ly, MD
nancy.ly@nm.org
262-455-1560
Time Frame
Start Date: 2026-02-03
Estimated Completion Date: 2027-03-05
Participants
Target number of participants: 25
Treatments
High tension group
Massive incisional ventral hernias with loss of domain undergoing open ventral hernia repair with transversus abdominis release with placement of mesh and closure of fascia under high tension.
Low tension group
Incisional ventral hernias undergoing open ventral hernia repair with transversus abdominis release with placement of mesh and closure of fascia under low tension.
Control
Healthy human subjects
Related Therapeutic Areas
Sponsors
Leads: Northwestern University

This content was sourced from clinicaltrials.gov

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