Recruiting

Observational Study

Sponsor:

Northwestern University

Code:

NCT07422584

Conditions

Incisional Ventral Hernia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Not applicable- observational study

Study Details

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.

Conditions

Incisional Ventral Hernia

Study ID

NCT07422584

Start date

Feb 3, 2026

Status verified date

Feb, 2026

Completion date

Mar 5, 2027

Anticipated

Primary completion date

Feb 5, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

25 participants

Anticipated

Interventions and Outcome Measures

Arms

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

Interventions

Not applicable- observational study

There are no interventions in this observational study.

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 and Locations

Central contacts

Megan Melland-Smith, MD

312-907-1414megan.mellandsmith@nm.org

Nancy Ly, MD

262-455-1560nancy.ly@nm.org

Locations

Northwestern Memorial Hospital

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Megan Melland-Smith, MD

312-907-1414megan.mellandsmith@nm.org

Nancy Ly, MD

262-455-1560nancy.ly@nm.org

More Information

Sponsor

Northwestern University

Last update posted

Feb 20, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Northwestern University on 2026-02-20.