Health Condition 1: O94- Sequelae of complication of pregnancy, childbirth, and the puerperium
Conditions
Interventions
Intervention1: STERIZONE®: STERIZONE® is a semi permeable waterproof wound dressing with silver for post-operative applications. It has a silver fabric layer edge laminated between two non-adherent po
Sponsors
Dynamic Techno Medicals Private Limited
Eligibility
Inclusion criteria
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
Exclusion criteria: •Woman with BMI > 30 Kg/m2 •Woman with hemoglobin levels •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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| •To compare Sterizone® and standard gauze post-operative surgical dressing for wound composite outcome of one or more of the following: superficial surgical site infection, hematoma, seroma or wound dehiscence within 30 days from the day of surgery.Timepoint: Day0 Day3to8 Day9to15 Day30/Early Termination visits | — |
Secondary
| Measure | Time frame |
|---|---|
| • To evaluate peri-incisional skin condition or inflammation • To evaluate time to appearance of surgical site infection (and subtypes), hematoma, seroma or wound dehiscence • To evaluate length of hospitalisation, need for systemic antibiotic therapy, hospital re-admission and/or reoperation • To evaluate and compare the resultant scar and cosmesis post incisional wound healing • To assess the pain during application and removal of dressing • To assess the safety and material problems, as determined by adverse events (AE) attributed to both the dressings • To evaluate the acceptability of the dressing by the medical staff • To evaluate the subject overall satisfaction & assessment of dressing wear time with regard to safety, comfort and convenience Timepoint: Day 0, Day (3-8), Day 9-15, Day 30/Early termination visits | — |
Countries
India
Contacts
Public ContactDr Radhesh Kumar
WorkSure MedPharma Consultancy India Pvt Ltd
Outcome results
None listed