| CTRI Number |
CTRI/2024/07/071422 [Registered on: 26/07/2024] Trial Registered Prospectively |
| Last Modified On: |
25/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Study On Antimicrobial Prophylaxis And Incidence Of Surgical Site Infection |
|
Scientific Title of Study
|
Assessment Of Antimicrobial Prophylaxis And Incidence Of Surgical Site Infection Among Surgical Patients In A Tertiary Care Hospital |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aswathi C |
| Designation |
PG Student |
| Affiliation |
NGSM Institute of Pharmaceutical Sciences |
| Address |
Department of Pharmacy Practice,NGSM Institute of Pharmaceutical Sciences,NITTE(Deemed to be University),Paneer,Derlakatte,Mangaluru
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
8139001831 |
| Fax |
|
| Email |
aswathimukil@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Juno J Joel |
| Designation |
Associate Professor and Head |
| Affiliation |
NGSM Institute of Pharmaceutical Sciences |
| Address |
Department of Pharmacy Practice,NGSM Institute of Pharmaceutical Sciences,NITTE(Deemed to be University),Paneer,Derlakatte,Mangaluru
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9480470727 |
| Fax |
|
| Email |
junojoel@nitte.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Caren Dsouza |
| Designation |
Professor and unit head |
| Affiliation |
K.S.Hegde Medical Academy |
| Address |
Department of General Surgery,
K.S Hegde Medical Academy, NITTE (Deemed to be University)
Deralakatte, Mangaluru
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
8147003238 |
| Fax |
|
| Email |
drcaren@nitte.edu.in |
|
|
Source of Monetary or Material Support
|
| Department of General Surgery, Justice K.S Hegde Charitable Hospital, Deralakatte, Mangaluru, Karnataka 575018 |
| Department of Pharmacy Practice, NGSM Institute of Pharmaceutical Sciences, NITTE(Deemed to be University), Paneer, Derlakatte, Mangaluru, Karnataka 575018 |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 Caren Dsouza |
Justice K S Hegde Charitable Hospital |
Department of General
Surgery, Justice K S
Hegde Charitable
Hospital, Deralakatta,
Mangaluru Dakshina
Kannada KARNATAKA
Dakshina Kannada
KARNATAKA |
8147003238
drcaren@nitte.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NGSM Institute of Pharmaceutical Sciences Institutional Ethics Committee (NGSMIPS-IEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged 18 years and above with clean, clean contaminated, and contaminated types of wounds will be included in the study. |
|
| ExclusionCriteria |
| Details |
Patients with dirty/ infected wounds, pregnant women cancer, and psychiatric patients will be excluded from the study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The study helps to identify the compliance with surgical antimicrobial prophylaxis |
8 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To identify the incidence of surgical site infection |
8 months |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
05/08/2024 |
| 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="8"
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
|
INTRODUCTION Surgical site infections (SSIs) are infections associated with surgeries occurring within 30 days of a surgical incision or 90 days after a prosthetic material implantation. SSI can be effectively prevented by administering proper Surgical Antimicrobial Prophylaxis (SAP) therapy. With this background, the current study aims to evaluate SAP, assess the incidence of SSI, and various factors with SSI. Thus, the study is conducted to assess SAP and the incidence rate of SSI. OBJECTIVE To assess the compliance with surgical antibiotic prophylaxis, the incidence of Surgical site infection, and the factors associated with it. JUSTIFICATION OF THE STUDY From the literature evidence it is understood that the adherence to the SAP is low and the incidence of SSI is high, this can increase the treatment cost and affect the patient’s quality of life. So, the current study aims to assess SAP practices and the incidence rate of SSIs. METHODOLOGY A prospective cross-sectional study will be conducted in the Department of Surgery, Justice K.S. Hegde Charitable Hospital with 150 patients (The sample size was calculated based on a 5% level of significance and considering 8% absolute precision) for 8 months. Patients aged 18 years and above with clean, clean contaminated, and contaminated types of wounds will be included in the study. Patients with dirty/ infected wounds, pregnant women cancer, and psychiatric patients will be excluded from the study. The study subjects will be enrolled after obtaining written consent. The study parameters include antimicrobial prophylaxis (as per WHO guidelines), incidence of surgical site infection and associated factors. The collected data will be documented electronically in Microsoft Excel 2019 and statistically analyzed using SPSS version 29. STATISTICAL ANALYSIS Categorical data will be expressed as frequency and percentage SPSS version 29 will be used for statistical analysis. OUTCOME MEASURES The study helps in identifying the compliance with SAP and its incidence of SSI. The study identifies various factors associated with SSI. |