A prospective, randomized, open-label study to compare the efficacy and safety of Sterizone® post-operative silver based wound dressing versus standard gauze dressing in women having elective and emergent caesarean section

Cesarean delivery (also called a cesarean section or C-section) is the surgical delivery of a baby by an incision through the mother’s abdomen (belly) and uterus (womb). This procedure is done when the surgeon determined it to be safer method than vaginal delivery for the mother, baby, or both.

In India, the rates of caesarean deliveries have more than doubled from 8% of deliveries in 2005 to 17% of deliveries in 2016. Surgical site infection (SSI) is one of the most common complications following cesarean section, and has an incidence of 3%–15% (Zuarez-Easton et al., 2017). It places physical and emotional burdens on the mother herself and a significant financial burden on the health care system. Affected women are more likely to have prolonged hospitalization, hospital readmission, reoperation, and additional antibiotic therapy. It is estimated that each SSI adds $3,400-$3,700 to the healthcare costs. Moreover, SSI is associated with a maternal mortality rate of up to 3% (Zuarez-Easton et al., 2017). Given the burden in morbidity and cost, there is a heightened focus on reduction of SSI in association with caesarean delivery.

 Because of its unique antimicrobial properties, silver has been used for centuries to reduce infection. Krieger et al, 2011 described silver as a metal that is relatively inert and poorly absorbed by cells. When it is exposed to a wound, it ionizes and becomes highly reactive to proteins and cell membranes. It has been shown to interact with structural proteins and DNA, inhibiting bacterial replications and causing fatal structural changes within bacterial cell walls. Prospective and retrospective studies in other specialties such as colorectal surgery and orthopedic surgery demonstrating a decreased rate of SSI with use of silver dressings have resulted in an interest in its use for cesarean wounds (Abboud et al., 2014).

 Sterizone®, a product from Dynamic Techno Medicals Private Limited, is a semi permeable waterproof silver based wound dressing for post-operative applications. Sterizone® post-operative dressing has a silver fabric layer edge laminated between two non-adherent polyethylene (PE) nets (one layer of PE net is the wound contact layer and the other one is laminated to an absorbent pad. The outermost layer is a polyurethane (PU) film which is transparent and waterproof in its nature which prevents the bacterial ingress. The PU film is bonded to the absorbent pad using acrylic adhesive.The metallic silver upon interaction with moisture, generate silver ions and act as an antimicrobial barrier for bacterial penetration of the dressing which may help reduce infection. The ions kill the bacteria bound to the wound and within the dressing. Sterizone® has been subjected to in vitro biocompatibility tests, i.e cytotoxicity, sensitization and irritation to prove its biocompatible nature.

The present study will compare Sterizone® post-operative silver based wound dressing with standard gauze dressing in subjects undergoing cesarean delivery.