| CTRI Number |
CTRI/2022/02/040086 [Registered on: 07/02/2022] Trial Registered Prospectively |
| Last Modified On: |
07/02/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Preventive |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to study the effect of aseptic measures on the surgical wound of repeat caesarean deliveries |
|
Scientific Title of Study
|
Impact of asepsis bundle on cesarean surgical site among women undergoing repeat caesarean delivery |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Akshita Kamboj |
| Designation |
Post Graduate Resident |
| Affiliation |
UCMS and GTB hospital, new delhi |
| Address |
Department of Obstetrics and Gynaecology, UCMS and GTB hospital, New delhi
East
DELHI
110095
India |
| Phone |
09728462069 |
| Fax |
|
| Email |
akshita_kamboj@outlook.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Richa Sharma |
| Designation |
Professor |
| Affiliation |
UCMS and GTB hospital, new delhi |
| Address |
Department of Obstetrics and Gynaecology, UCMS and GTB hospital, New Delhi
East
DELHI
110095
India |
| Phone |
7011484180 |
| Fax |
|
| Email |
gautamdrricha1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Akshita Kamboj |
| Designation |
Post Graduate Resident |
| Affiliation |
UCMS and GTB hospital, new delhi |
| Address |
Department of Obstetrics and Gynaecology, UCMS and GTB hospital, New Delhi
East
DELHI
110095
India |
| Phone |
9728462069 |
| Fax |
|
| Email |
akshita_kamboj@outlook.com |
|
|
Source of Monetary or Material Support
|
| Unicersity College of Medical Sciences, Dilshad Garden, New Delhi |
|
|
Primary Sponsor
|
| Name |
university college of medical sciences |
| Address |
university college of medical sciences and GTB hspital new Delhi |
| Type of Sponsor |
Government 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 Akshita Kamboj |
UCMS and GTB Hospital |
7th floor, MCH Building, Department of Obstetrics and Gynecology University College of Medical Sciences and GTB hospital New delhi
East
DELHI |
09728462069
akshita_kamboj@outlook.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics comittee-human research (IEC-HR) university college of medical sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O860||Infection of obstetric surgical wound, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ASEPSIS Bundle group |
1.No Hair removal or with clippers
2.Preoperative bath with 4% chlorhexidine.
3.Antimicrobial prophylaxis with cefazolin.
4. Skin preparation with 4% chlorhexidine &
70% isopropyl alcohol.
5. Vaginal preparation with 4% chlorhexidine
only
6. Skin closure with Nylon (Ethilon 1.0) suture
7. Post-operative bath with chlorhexidine soap.
8. Suture removal on day 14 |
| Comparator Agent |
conventional management |
1. Hair removal cream for part preparation
2. Preoperative bath with non-medicated soap
3. Antimicrobial prophylaxis with ceftriaxone 1gm intravenously single dose
4. Skin preparation with povidone-iodine
solution
5. No vaginal preparation pre-operatively
6. Skin closure with Surgical Silk No.1 suture.
7. Postoperative bath with non-medicated soap
8. Suture removal on day 10 |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1.Pregnant women with period of gestation more than 28 weeks undergoing elective
2.repeat caesarean section not in labor.
3.History of previous one or two caesarean sections
4.Willing to follow up in UCMS & GTB Hospital. |
|
| ExclusionCriteria |
| Details |
1. Patients with leaking per vaginum or chorioamnionitis
2. Patients with the following high risk factors at the time of recruitment will be excluded
2a Moderate or Severe anemia
2b Gestational or pre-gestational diabetes mellitus
2c Immunocompromised patients
2d BMI >30 kg/m2
2e Smoking
3 Patients with history of surgical site infection in the previous caesarean scar.
4 Any skin condition around surgical site
5 Patients allergic to chlorhexidine |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
|
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Numbers of patients developing surgical site infections within 30 days after caesarean
delivery, defined as superficial, deep or organ space infection according to Centers for
Disease Control and Prevention(CDC) and National Healthcare Safety Network (NHSN)
in both the groups. |
At Day 3
At Day 14
At Day 21
At Day 30 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Length of hospital stay (in days) in both groups |
at time of discharge |
| Number of patients undergoing resuturing in both groups |
within 30 days |
| Number of patients having adverse effect of bundle components |
at baseline |
| Organism isolated in pus culture |
at time of infection |
|
|
Target Sample Size
|
Total Sample Size="130"
Sample Size from India="130"
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)
|
08/02/2022 |
| 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="1"
Months="4"
Days="2" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
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 complications associated with caesarean section
which may lead to a substantial effect on the mother’s health and impose enormous demands
on healthcare-system resources. Significant association has been observed between repeat
caesarean sections and wound infection. Asepsis bundle includes a set of evidence-based
measure that have shown a significant improvement in patient care.
The aim of this trial is to study the impact of ASEPSIS bundle on caesarean surgical site among women
undergoing repeat caesarean delivery. |