| CTRI Number |
CTRI/2024/04/066286 [Registered on: 25/04/2024] Trial Registered Prospectively |
| Last Modified On: |
21/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Descriptive observational study |
| Study Design |
Other |
|
Public Title of Study
|
Microbiological profile of surgical site infections following surgical procedures in the department of obstetrics and gynaecology - a descriptive observational study |
|
Scientific Title of Study
|
Microbiological profile of surgical site infections following surgical procedures in the department of obstetrics and gynaecology- a descriptive observational 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 Shefali garg |
| Designation |
MS obstetrics and gynaecology |
| Affiliation |
Jawaharlal nehru medical college, KLE university |
| Address |
Department of obstetrics and gynaecology, Jawaharlal nehru medical college, Nehru nagar, KLE Hospital road
Belgaum
Karnataka
590010
Belgaum KARNATAKA 590010 India |
| Phone |
9113553468 |
| Fax |
|
| Email |
shefalig.08@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Anita Dalal |
| Designation |
Professor |
| Affiliation |
Jawaharlal nehru medical college, KLE University |
| Address |
Department of obstetrics and gynaecology , Jawaharlal Nehru medical college, Nehru nagar, KLE Hospital road
Belgaum
KARNATAKA
590010
Belgaum KARNATAKA 590010 India |
| Phone |
9448140343 |
| Fax |
|
| Email |
anitamgan@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr. Shefali Garg |
| Designation |
MS obstetrics and gynaecology |
| Affiliation |
Jawaharlal nehru medical college, KLE University |
| Address |
Department of obstetrics and gynaecology , Jawaharlal Nehru medical college, Nehru nagar, KLE Hospital road
Belgaum
KARNATAKA
590010
Belgaum KARNATAKA 590010 India |
| Phone |
9113553468 |
| Fax |
|
| Email |
shefalig.08@gmail.com |
|
|
Source of Monetary or Material Support
|
| KLEs Dr Prabhakar Kore hospital, Jawaharlal Nehru Medical College, KLE University , Belagavi |
|
|
Primary Sponsor
|
| Name |
Jawaharlal Nehru medical college KLE University Belagavi |
| Address |
Department of obstetrics and gynaecology, Jawaharlal Nehru Medical College , KLE Hospital road, Belagavi, Karnataka , 590010 |
| 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 Shefali Garg |
KLEs Dr Prabhakar kore hospital, Belagavi |
Department of obstetrics and gynaecology , Jawaharlal Nehru Medical College, Nehru nagar , KLE hospital road
Belgaum KARNATAKA |
9113553468
shefalig.08@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JNMC Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O989||Unspecified maternal infectious and parasitic disease complicating pregnancy, childbirth and the puerperium, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Female |
| Details |
All the women undergoing surgical procedures in the department of obstetrics and gynaecology and developing surgical site infections. |
|
| ExclusionCriteria |
| Details |
Surgical procedures done outside our hospital, admitted following
wound infections.
Women with wound infections occurring after 30 days of surgery.
Women declining for informed consent. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the microbiological profile of surgical site infections following surgical procedures |
1yr hospital based study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine the incidence and risk factors for surgical site infections following surgical procedures |
1 yr hospital based study |
|
|
Target Sample Size
|
Total Sample Size="120" Sample Size from India="120"
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)
|
03/05/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
03/05/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 infection is defined as an infection occurring within 30 days after a surgical operation and affecting either incision er deep tissues at the operation site. These infections may be a superficial or deep incisional infection or infections
atvolving organ or body space. The need for the study is
1. Postoperative SSI is among the most common problems for patients who undergo surgical procedures. It is associated with increased morbidity,
mortality, prolonged hospital stay, secondary infertilay and increased economic costs for patient care
2. The incidence of pestoperative SSI varies widely between procedure, hospitals, surgeons, patients and geographical incations. There has been advance in SS1 control practices which include improved operating soom ventilation, sterilization methods, use of barriers, surgical techniques and availability of antimicrobial prophylaxis. Despite these, SSla still occur.
3. This is partly contributed by the emergence of antimicrobial resistant pathogenic hacteria. Reported risk factors for surgical site infection include emergency caesarean section, prolonged labour prior to caesarean section, prolonged rupture of membranes, multiple vaginal examinations, and prolonged abstracted labour Other factors are inadequate skills or poor technique of the surgeon, prolonged operating time, prolonged obstructed labour, postoperative anemia, high body mass index, diabetes mellitus, inanunosuppressive disorders and certain
modications like steroids.
Potential sources of infection idemified inchade anfihered an, amseptic
solutions, transporting of patients, surgical seam, over-crowding in theatre, theatre gowns, inadequately sterilised equipment, contaminated environment and grously contaminated surfaces.
Complications of SS1s include prolonged wound healing, wound dehiscence, wound pain, burst abdomen, necrotizing fasciitis and pelvic abscess. Others prolonged admission, a prolonged course of antibiotics, the possibility of re admission, secondary nepair surgery, incisional bernis, disfiguring scar, and in rare condition can lead to severe sepsis and mortality.
6. Surgical site infections also affects the physical, emotional, social and economic aspects of life |