| CTRI Number |
CTRI/2025/07/090502 [Registered on: 08/07/2025] Trial Registered Prospectively |
| Last Modified On: |
01/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Dressing] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
EFFECTIVENESS OF COPPER DRESSINGS IN CAESAREAN WOUND HEALING |
|
Scientific Title of Study
|
EFFICACY OF COPPER IMPREGNATED WOUND
DRESSING FOR WOUND HEALING IN REPEAT
CAESAREAN DELIVERY : A PILOT STUDY |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. Swarnima Agrawal |
| Designation |
PG Student (Obstetrics & Gynaecology) |
| Affiliation |
University college of medical Sciences and GTB hospital |
| Address |
University college of medical sciences and GTB hospital
Dilshad Garden, Delhi
North West
DELHI
110095
India |
| Phone |
9818041726 |
| Fax |
|
| Email |
swarnimaagrawal1998@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Richa Sharma |
| Designation |
Director Professor (Obstetrics and Gynaecology) |
| Affiliation |
University college of medical Sciences and GTB hospital |
| Address |
Department of Obstetrics and Gynaecology, University college of medical sciences and GTB hospital
Dilshad Garden, Delhi
North East
DELHI
110095
India |
| Phone |
7011484180 |
| Fax |
|
| Email |
gautamdrricha1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Swarnima Agrawal |
| Designation |
PG Student (Obstetrics & Gynaecology) |
| Affiliation |
University college of medical Sciences and GTB hospital |
| Address |
University college of medical sciences and GTB hospital
Dilshad Garden, Delhi
North East
DELHI
110095
India |
| Phone |
9818041726 |
| Fax |
|
| Email |
swarnimaagrawal1998@gmail.com |
|
|
Source of Monetary or Material Support
|
| MedCu Technologies
Ltd. Herzliya, Israel Manufacturer and BL Lifesciences Pvt. Ltd., A-245, Okhla Phase-1,
3
Delhi Importer |
|
|
Primary Sponsor
|
| Name |
Med Cu Technologies Ltd |
| Address |
MedCu Technologies
Ltd. Herzliya, Israel" (Manufacturer) and “BL Lifesciences Pvt. Ltd., A-245, Okhla Phase-1,
3
Delhi” (Importer) |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Swarnima Agrawal |
GTB Hospital |
Gynaecology office, 7th floor, MCH building
North East
DELHI |
9818041726
swarnimaagrawal1998@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE – HUMAN RESEARCH (IEC-HR) UNIVERSITY COLLEGE OF MEDICAL SCIENCES, UNIVERSITY OF DELHI, DELHI - 110095 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 1||Obstetrics, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control group : Conventional wound dressings as per hospital protocol |
For Group B (Control group), after skin closure of repeat caesarean section, conventional wound dressings as per hospital protocol (povidone iodine and sterile gauze) will be applied for 7 days. |
| Intervention |
Copper dressing |
For group A (Copper impregnated wound dressing group) After skin closure of repeat caesarean section, Copper impregnated wound dressing will be applied for 7 days. |
|
|
Inclusion Criteria
|
| Age From |
0.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Female |
| Details |
Pregnant women of any age and parity with gestational age more than 28 weeks and undergoing repeat caesarean section, either emergency or elective.
Patients who are willing to follow up in UCMS & GTB Hospital |
|
| ExclusionCriteria |
| Details |
Patients with Hepatitis B Hepatitis C HIV or Syphilis.
Patients with any dermatological condition around the surgical site
Patients allergic to Copper or Wilson’s Disease.
Any acute febrile illness. |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Measure: Mean REEDA (Redness, Edema, Ecchymosis, Discharge, Approximation) score in both the groups on day 7, day 10 and day 30. |
Measure: Mean REEDA (Redness, Edema, Ecchymosis, Discharge, Approximation) score in both the groups on day 7, day 10 and day 30. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Incidence of SSI among both the groups.
Length of hospital stay.
Readmission & resuturing rates due to wound comorbidities like discharge, gape etc. in both the groups.
Side effect of using copper impregnated dressings such as erythema, itching, edema, etc.
Comorbidities associated with wound complications. |
End of the trial |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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 3 |
|
Date of First Enrollment (India)
|
14/07/2025 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Surgical site infections are complicationsassociated with caesarean delivery which may lead to a substantial effect on the mother’s health. Repeat caesarean have significant association with wound infections. Copper not only acts as an antimicrobial agent but also stimulates wound healing. Copper impregnated wound dressing has been significantly associated with healing of chronic non healing wounds like diabetic ulcer, pressureulcers, first and second degree wounds and many more. Hence, we plan to study the effect of copper impregnated wound dressing in repeat caesarean delivery for primary wound healing and risk for surgical site infections following the same. |