Postoperative comparison of Sterizone® dressing versus standard gauze dressing in women having cesarean sectio

Phase 4

• Conditions: Health Condition 1: O94- Sequelae of complication of pregnancy, childbirth, and the puerperium

• Registration Number: CTRI/2022/10/046881
• Lead Sponsor: Dynamic Techno Medicals Private Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 21 August 2023

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

•Primiparous or multiparous woman aged 18-40 years

•Woman having gestation between 24(0/7) and 40(6/7) weeks

•Woman with single or multiple gestations

•Woman with elective or emergent cesarean deliveries

•Woman with primary or repeat cesarean sections

•Woman with Pfannenstiel or low transverse skin incisions

•Woman with good systemic/mental health as per opinion of the PI

•Woman with CDC surgical wound classification class I

•Woman providing written informed consent

Exclusion Criteria

•Woman with BMI > 30 Kg/m2

•Woman with hemoglobin levels < 7g/dL

•Woman that did not receive routine prophylactic dose of antibiotics in the operating room.

•Woman with skin incisions other than Pfannenstiel or low transverse incisions

•Woman requiring more than one incision

•Woman having urogenital tract infection within 2 weeks before cesarean delivery

•Woman with known or discovered allergy to suture material or silver

•Woman with active neoplastic lesion treated with radiation or chemotherapy

•Woman requiring MRI (Magnetic Resonance Imaging) examination during the course of the study

•Woman with active skin infection, and coagulopathy

•Woman prone to develop keloids or have developed keloid with any past surgery

•Woman taking systemic immunosuppressant (excluding steroids for lung maturity), or known case of HIV

•Woman with high likelihood of additional surgical procedure beyond cesarean (e.g., scheduled hysterectomy, bowel, or adnexal surgery)

•Woman already participating in another surgical study

•Woman who received an experimental drug or used an experimental medical device within 3 months of becoming pregnant

•Woman unlikely to comply with surgical procedure or complete the scheduled follow up visit, in the opinion of PI

•Employees of the PI or study center with direct involvement in the proposed study or other studies under the direction of that PI or study center

•Any confirmed or suspected SARS-CoV-2virus/variant or COVID-19 disease

•Other indication-based exclusion, in opinion of PI

Study & Design

• Study Type: Interventional
• Study Design: Not specified