Cytokine Response to Abdominal Wall Reconstruction

Conditions

• Incisional Ventral Hernia

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Accepted

Interventions

• Not applicable- observational study — OTHER
  There are no interventions in this observational study.

Study Details

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.

Key Dates

Start date

Feb 3, 2026

Status verified

Feb 2026

Primary completion

Feb 5, 2027

Completion

Mar 5, 2027

Study Design

Enrollment

25 participants (estimated)

Arms

• Arm: 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.
• Arm: 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.
• Arm: Control
  Healthy human subjects

Primary Outcome Measure

Determine whether fascial closure tension correlates with systemic and peritoneal fluid cytokine activation. [ Time Frame: Baseline through postoperative day 5 ]

Central Contacts

• Megan Melland-Smith, MD
  312-907-1414
  [email protected]
• Nancy Ly, MD
  262-455-1560
  [email protected]

Locations (1)

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