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Search / Trial NCT07066254

The Mepilex Cesarean Delivery Trial

Launched by MONTEFIORE MEDICAL CENTER · Jul 4, 2025

Trial Information

Current as of November 14, 2025

Not yet recruiting

Keywords

Surgical Site Infection Surgical Wound Infection Postoperative Complications Cesarean Section Obstetric Surgical Procedures Pregnant Women Wound Dressing Randomized Controlled Trial Patient Satisfaction Anti Infective Agents, Local Infection Control Silver Antimicrobial Foam Mepilex

ClinConnect Summary

This clinical trial is studying whether a special silver-containing foam dressing called Mepilex Ag can help prevent infections after a cesarean delivery (C-section). Researchers want to find out if this silver dressing lowers the chance of getting an infection at the surgical site compared to the standard dressing usually used after surgery.

Women who are 18 years or older and scheduled for a planned C-section at the study hospital may be eligible to join, as long as they can understand English or Spanish and have a phone for follow-up calls. After the C-section, participants will be randomly given either the silver foam dressing or the regular dressing on their surgical wound. They will then be monitored during the weeks after delivery to check for any signs of infection or wound problems. The trial is not yet recruiting, but it aims to help improve care and recovery for women having C-sections by finding the best way to protect their surgical wounds.

Gender

FEMALE

Eligibility criteria

  • Inclusion Criteria:
  • Age 18 years or older
  • Undergoing non-emergent cesarean delivery at our institution
  • Able to provide informed consent in English or Spanish
  • Has a working telephone number for follow-up communication
  • Exclusion Criteria:
  • Known hypersensitivity or allergy to silver, Aquacel Ag, or adhesive materials
  • Presence of active skin infection or open skin condition at the planned dressing site
  • Participation in another interventional trial affecting wound healing or surgical outcomes
  • Immunocompromised status (e.g., current chemotherapy, chronic steroid use, or known HIV with CD4 \<200)
  • Intraoperative conversion to vertical skin incision or other nonstandard approach
  • Inability to complete follow-up due to anticipated relocation, incarceration, or other logistical barrier

About Montefiore Medical Center

Montefiore Medical Center is a leading academic medical institution located in the Bronx, New York, renowned for its commitment to advancing healthcare through innovative research and clinical trials. As a principal sponsor of clinical studies, Montefiore fosters a collaborative environment that connects researchers, healthcare professionals, and patients to explore cutting-edge therapies and improve health outcomes. With a strong emphasis on patient-centered care, the center integrates its extensive clinical expertise with robust research capabilities to address a wide range of medical conditions, contributing significantly to the advancement of medical science and clinical practice.

Locations

Bronx, New York, United States

Patients applied

0 patients applied

Trial Officials

Georgios Doulaveris

Principal Investigator

Montefiore Medical Center

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported