| CTRI Number |
CTRI/2022/10/046881 [Registered on: 28/10/2022] Trial Registered Prospectively |
| Last Modified On: |
24/07/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Postoperative comparison of Sterizone® dressing versus standard gauze dressing in women having cesarean section |
|
Scientific Title of Study
|
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 |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| IND-DTMPL-STERIZONE-2022-2, V 2.0 15 Feb 2022 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sreekumar Menon |
| Designation |
Joint Managing Director |
| Affiliation |
Dynamic Techno Medicals Private Limited |
| Address |
Dynamic Techno Medicals Private Limited.
P.B. No. 45, Ashokapuram, Aluva, Kerala, India.
Ernakulam KERALA 683101 India |
| Phone |
04842837788 |
| Fax |
|
| Email |
sreekumar@dynamictechnomedicals.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Ankit Pathak |
| Designation |
Medical Director |
| Affiliation |
WorkSure MedPharma Consultancy India Pvt Ltd |
| Address |
AB-8, IInd Floor, Safdarjung Enclave Community Centre,
Near Safdarjung Club, New Delhi
South DELHI 110029 India |
| Phone |
01140678686 |
| Fax |
|
| Email |
ankit.pathak@worksuremedpharma.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Radhesh Kumar |
| Designation |
Scientific Consultant |
| Affiliation |
WorkSure MedPharma Consultancy India Pvt Ltd |
| Address |
AB-8, IInd Floor, Safdarjung Enclave Community Centre,
Near Safdarjung Club, New Delhi
South DELHI 110029 India |
| Phone |
01140678686 |
| Fax |
|
| Email |
radheshkumar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dynamic Techno Medicals Private Limited.
P.B. No. 45, Ashokapuram, Aluva, Kerala, India
683101 |
|
|
Primary Sponsor
|
| Name |
Dynamic Techno Medicals Private Limited |
| Address |
Joint Managing Director
Dynamic Techno Medicals Private Limited.
P.B. No. 45, Ashokapuram, Aluva, Kerala, India-683101
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shyamla Kaitala |
King George Hospital |
Department of Gynaecology
King George Hospital,
Maharanipeta, Visakhapatnam,
Andhra Pradesh–530002
Visakhapatnam ANDHRA PRADESH |
9989453046
Drkshyamalaresearch@gmail.com |
| Dr Anita Bansal |
Maharaja Agrasen Hospital |
Department of Obstetrics and Gynaecology
Maharaja Agrasen Hospital,West Punjabi Bagh,New-Delhi-110026
South West DELHI |
9810054171
anitamdms@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Hamdard Institute Of Medical Sciences & Research |
Approved |
| KIng George Hospital Institutional Ethics Committee |
Approved |
| Maharaja Agrasen Hospital Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O94||Sequelae of complication of pregnancy, childbirth, and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Standard Gauze |
Standard dressing will be gauze and adhesive tape that will be placed immediately after skin closure under sterile conditions in women in the operating room over the cesarean delivery incision after the completion of procedure. Subjects will be screened, recruited and randomized over 60 days period. Subjects will be admitted one day before the surgery and will be followed for up to 30 days after the surgery. Total duration of study will be 90 days. |
| Intervention |
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 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. Sterizone® is intended to be used for management of post-operative wounds, lacerations and abrasions. In this study, it will be applied in the operating room over the cesarean delivery incision after the completion of procedure.This dressing will be applied immediately after skin closure as per the manufacturer’s instructions under sterile conditions.
Subjects will be screened, recruited and randomized over 60 days period. Subjects will be admitted one day before the surgery and will be followed for up to 30 days after the surgery. Total duration of study will be 90 days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
• 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
|
|
| ExclusionCriteria |
| Details |
•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
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| • 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. |
Day0 Day3to8 Day9to15 Day30/Early Termination visits |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• 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
|
Day 0, Day (3-8), Day 9-15, Day 30/Early termination visits |
|
|
Target Sample Size
|
Total Sample Size="200" Sample Size from India="200"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/11/2022 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0" Months="3" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
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. |