| CTRI Number |
CTRI/2019/05/019083 [Registered on: 13/05/2019] Trial Registered Prospectively |
| Last Modified On: |
24/07/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Process of Care Changes |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
PREVENTION OF surgical INFECTIONS IN GYNAECOLOGICAL SURGERIES |
|
Scientific Title of Study
|
IMPLEMENTATION OF SURGICAL SITE INFECTION PREVENTION BUNDLE IN GYNAECOLOGICAL SURGERIES: A QUALITY CONTROL INITIATIVE |
| Trial Acronym |
SIP TRIAL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
BHANU PRIYA |
| Designation |
ASSOCIATE PROFESOR |
| Affiliation |
obstetrics and gynecology, university college of medical sciences and guru teg bahadur hospital |
| Address |
GURU TEG BAHADUR HOSPITAL, obstetrics and gynecology dept, MCH building room no 710 DILSHAD GARDEN DELHI
North East
DELHI
110095
India |
| Phone |
9650514269 |
| Fax |
|
| Email |
drpriyabhanu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
BHANU PRIYA |
| Designation |
ASSOCIATE PROFESOR |
| Affiliation |
obstetrics and gynecology, university college of medical sciences and guru teg bahadur hospital |
| Address |
GURU TEG BAHADUR HOSPITAL, obstetrica and gynecology deptt, MCH building, room no 710,DILSHAD GARDEN DELHI
North East
DELHI
110095
India |
| Phone |
9650514269 |
| Fax |
|
| Email |
drpriyabhanu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
BHANU PRIYA |
| Designation |
ASSOCIATE PROFESOR |
| Affiliation |
obstetrics and gynecology, university college of medical sciences and guru teg bahadur hospital |
| Address |
GURU TEG BAHADUR HOSPITAL, obstetrics and gynecology deptt, MCH building room no 710, DILSHAD GARDEN DELHI
North East
DELHI
110095
India |
| Phone |
9650514269 |
| Fax |
|
| Email |
drpriyabhanu@gmail.com |
|
|
Source of Monetary or Material Support
|
| guru teg bahadur hospital,dilshad garden delhi |
|
|
Primary Sponsor
|
| Name |
guru teg bahadur hospital |
| Address |
GURU TEG BAHADUR HOSPITAL, DILSHAD GARDEN 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 |
| bhanupriya |
guru teg bahadur hospital |
GURU TEG BAHADUR HOSPITAL, obstetrics and gynecology deptt, MCH building room no 710, DILSHAD GARDEN DELHI
North East
DELHI |
9650514269
drpriyabhanu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Guru Teg Bahadur hospital ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Y839||Surgical procedure, unspecified asthe cause of abnormal reaction of the patient, or of later complication, without mention of misadventure at the time of the procedure, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
chlorohexidine, closing pan |
intervention: chlorohexidine 2% at the start of surgery and closing pan at the end of sugery. rest as usual |
| Comparator Agent |
no intervention |
no intervention |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Male |
| Details |
All women who underwent abdominal gynecologic surgery will be included |
|
| ExclusionCriteria |
| Details |
Patients who are not operated in GTB hospital or coming with surgical site infection after getting discharge from the hospital will be excluded. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Primary objective: To assess the surgical site infection rates after implementation of bundle in all gynecological surgeries. |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) To assess the rate and causative organisms of superficial, deep incisional and deep organ space surgical site infections rates by microbiological cultures
2) To assess markers for post operative infectious morbidity like fever, duration of surgery, wound dehiscence, etc, resuturing, duration of hospital stay, blood transfusion etc
|
30 days |
|
|
Target Sample Size
|
Total Sample Size="170"
Sample Size from India="170"
Final Enrollment numbers achieved (Total)= "170"
Final Enrollment numbers achieved (India)="170" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/05/2019 |
| Date of Study Completion (India) |
30/05/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
30/05/2020 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
not done |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Any surgical procedure carries risk of complications. Surgical Site Infections (SSI) remains a major challenge in clinical practice. The CDC definition4 describes three levels of SSI: Superficial incisional, Deep incisional, Organ or space infection
A bundled intervention includes all the preoperative, intraoperative and postoperative interventions to avoid SSI.
Procedure All women undergoing gynecologic surgeries through abdominal route for any indication will be included in the study. The women will be divided into the preintervention and intervention group as discussed under heading of sample size calculation. Demographic and clinical details of the women will be recorded as per the proforma. A written and informed consent will be taken from all the women. In the interventional group, after having bath on morning of surgery, routine antibiotic (Injection Ceftriaxone 1g IV) at least 20 minutes before the surgery will be administered. Surgical site of women in intervention group will be prepped with 2% Chlorhexidine-gluconate solution first followed by 70% alcohol and 5% povidone iodine. At the end of the procedure gloves and closing sterile instruments, electrocautery device, suction tip will be changed and OT gown of surgeon and nurse, if contaminated. During surgery euglycemia and normothermia will be maintained. On postoperative day 3, dressing of surgical site will be done with spirit and wound will be examined for any discharge and induration. Patients would be discharged on postoperative day 4 unless otherwise indicated. For Pfannenstiel incision stitches would be removed on postoperative day 8 and midline incisions stitch removal will be done on postoperative day 10. Temperature will be recorded twice a day during hospital stay. Wound cultures for aerobes and anaerobes will be sent in case of wound infections. Patients who would undergo resuturing or conservative management of wound (as per hospital protocols) will be recorded on proforma. Any readmission within 30 days of discharge will be recorded.
|