| CTRI Number |
CTRI/2025/02/080629 [Registered on: 14/02/2025] Trial Registered Prospectively |
| Last Modified On: |
13/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to study the effect of two procedures, Surgical Bundle with Preoperative Skin Preparation and Vaginal Cleaning
and Surgical Bundle without Preoperative Skin Preparation and Vaginal Cleaning on
Prevention of Surgical Site Infections in women undergoing Caesarean Section |
|
Scientific Title of Study
|
Effect of Surgical Bundle with Preoperative Skin Preparation and Vaginal Cleaning
versus Surgical Bundle without Preoperative Skin Preparation and Vaginal Cleaning on
Prevention of Surgical Site Infections in women undergoing Caesarean Section- A Randomised
Controlled Trial |
| 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 Shivangi Ghildiyal |
| Designation |
Junior Resident |
| Affiliation |
NKP Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital |
| Address |
Room No.3, 3rd floor, Department of Obstetrics and Gynaecology
Digdoh Hills, Hingna Road, Nagpur
Nagpur
MAHARASHTRA
440019
India |
| Phone |
7447858968 |
| Fax |
|
| Email |
shivangighildiyal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Savita Somalwar |
| Designation |
Associate Professor |
| Affiliation |
NKP Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital |
| Address |
Room No.3, 3rd floor, Department of Obstetrics and Gynaecology
Digdoh Hills, Hingna Road, Nagpur
Nagpur
MAHARASHTRA
440019
India |
| Phone |
9158920941 |
| Fax |
|
| Email |
somalwar.sa@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Savita Somalwar |
| Designation |
Associate Professor |
| Affiliation |
NKP Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital |
| Address |
Room No.3, 3rd floor, Department of Obstetrics and Gynaecology
Digdoh Hills, Hingna Road, Nagpur
Nagpur
MAHARASHTRA
440019
India |
| Phone |
9158920941 |
| Fax |
|
| Email |
somalwar.sa@gmail.com |
|
|
Source of Monetary or Material Support
|
| NKP Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital,
Nagpur, Maharashtra, India- 440019 |
|
|
Primary Sponsor
|
| Name |
NKP Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital |
| Address |
Digdoh Hills, Hingna Road,
Nagpur-440019 |
| Type of Sponsor |
Private medical college |
|
|
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 Shivangi Ghildiyal |
NKP Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital |
Room No. 3, 3rd Floor, Department of Obstetrics and
Gynaecology
Nagpur
MAHARASHTRA |
7447858968
shivangighildiyal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NKP Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital |
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 |
| Intervention |
Surgical bundle with preoperative skin preparation and vaginal cleaning |
Vaginal cleaning will be done using chlorhexidine 0.25% solution.
Skin preparation will be done using 0.25% chlorhexidine gluconate solution followed by Povidone Iodine. |
| Comparator Agent |
Surgical bundle without preoperative skin preparation and vaginal cleaning |
There will be no vaginal cleaning or preoperative skin preparation. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Patients undergoing caesarean section both elective and emergency.
The patient who has given consent for the study.
|
|
| ExclusionCriteria |
| Details |
Patients with comorbidities like Diabetes Mellitus.
Patients with a body mass index of more than 30 kilograms per meter square.
Patients with Premature Rupture of membranes for more than 18 hours.
Patients with severe anemia with hemoglobin less than 7 grams per decilitre.
Patient with recent infections at the site of the incision before caesarean section.
Patients already suffering from fever. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Suture Site Examination |
Day 2, day 4, and day 9 post-operatively. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="170"
Sample Size from India="170"
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
|
N/A |
|
Date of First Enrollment (India)
|
24/02/2025 |
| 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="2"
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
|
Background: Caesarean section (CS) is the most common procedure globally with 32.1% of all deliveries. CS can be associated with Surgical Site Infections (SSIs) which can be reduced or prevented by applying proper techniques and thus, reduce the health care burden and also economic burden on the society. Hence, this study will be conducted to study the effect of surgical bundle with preoperative skin preparation and vaginal cleaning versus surgical bundle without preoperative skin preparation and vaginal cleaning on the prevention of surgical site infections in women undergoing caesarean section.Methodology: A total of 170 women undergoing CS will be randomized into two groups following computer-generated randomization. Group A (Experimental Group) will include caesarean section with surgical bundle with preoperative skin preparation and vaginal cleaning and Group B (Control Group) will include caesarean section with surgical bundle without preoperative skin preparation and vaginal cleaning. The data will be collected following the suture site examination on day 2, day 4, and day 9.Result: The data will be collected and will undergo statistical analysis with descriptive and inferential statistics. p-value < 0.05 will be considered statistically significant. Conclusion: The study will conclude the effect of the surgical bundle with preoperative skin preparation and vaginal cleaning in comparison with the surgical bundle without preoperative skin preparation and vaginal cleaning on the prevention of SSIs in women undergoing CS with statistical and clinical implications and differences. |