| CTRI Number |
CTRI/2023/07/055770 [Registered on: 27/07/2023] Trial Registered Prospectively |
| Last Modified On: |
10/04/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Does change of Gloves before Skin closure help prevent wound infection in Emergency surgeries? |
|
Scientific Title of Study
|
Comparative Study on the effect of change of Sterile Surgical gloves before wound closure on the rate of Surgical Site Infections in patients undergoing Emergency Abdominal Exploratory laparotomy in the setup of a Tertiary care center; A Prospective 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 Vipul Versi Nandu |
| Designation |
Assistant Professor |
| Affiliation |
HBT Medical College and Dr. R. N. Cooper Hospital |
| Address |
Department of General SUrgery, HBT Medical College and Dr. R. N. Cooper Hospital, Juhu, Vile-Parle west, Mumbai- 400056.
Mumbai (Suburban) MAHARASHTRA 400056 India |
| Phone |
|
| Fax |
|
| Email |
dr.vipulnandu@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Vipul Versi Nandu |
| Designation |
Assistant Professor |
| Affiliation |
HBT Medical College and Dr. R. N. Cooper Hospital |
| Address |
Department of General SUrgery, HBT Medical College and Dr. R. N. Cooper Hospital, Juhu, Vile-Parle west, Mumbai- 400056.
MAHARASHTRA 400056 India |
| Phone |
|
| Fax |
|
| Email |
dr.vipulnandu@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Vipul Versi Nandu |
| Designation |
Assistant Professor |
| Affiliation |
HBT Medical College and Dr. R. N. Cooper Hospital |
| Address |
Department of General SUrgery, HBT Medical College and Dr. R. N. Cooper Hospital, Juhu, Vile-Parle west, Mumbai- 400056.
MAHARASHTRA 400056 India |
| Phone |
|
| Fax |
|
| Email |
dr.vipulnandu@gmail.com |
|
|
Source of Monetary or Material Support
|
| HBT Medical College and Dr. R. N. Cooper Municipal General Hospital |
|
|
Primary Sponsor
|
| Name |
Government Medical College |
| Address |
HBT Medical College and Dr. R. N. Cooper Hospital |
| 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 Hemant Kale |
HBT Medical College and Dr. R. N. Cooper hospital, |
Juhu, Vile-Parle west, Mumbai. Mumbai (Suburban) MAHARASHTRA |
7977023286
dr.vipulnandu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K650||Generalized (acute) peritonitis, (2) ICD-10 Condition: K566||Other and unspecified intestinal obstruction, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
group with change of gloves |
second group -- change of gloves before closure of abdominal incision |
| Comparator Agent |
Without gloves change |
Continue with same sterile gloves used during entire surgery for abdominal incision closure |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. consented for the study
2. Patient undergoing Emergency abdominal Exploratory laparotomy through midline vertical incision for abdominal pathology. |
|
| ExclusionCriteria |
| Details |
i) Patients posted for elective/planned operations.
ii) Patients undergoing re-exploratory procedures.
iii) Immunocompromised individuals.
iv) Rest any other procedure in an Emergency setting that is done without a midline vertical incision
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study whether a change in gloves before wound closure helps prevent SSIs in patients undergoing Emergency Exploratory laparotomy. |
2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| ) To Identify the rate of SSI in emergency laparotomy procedures. |
2 weeks |
| 2) To Compare rates of SSI in Case & control arm. |
2 weeks |
| 3) To study the Effect of change of gloves before wound closure on rates of SSI. |
2 weeks |
|
|
Target Sample Size
|
Total Sample Size="200" Sample Size from India="200"
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)
|
09/08/2023 |
| 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="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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
|
1)
Surgical site infections (SSI) are among the most common hospital-acquired infections in patients
undergoing Emergency Abdominal exploratory surgeries for Bowel perforations,
obstructions, etc.
2)
In recent years SSIs are
accounting for 36.4% of infections reported to the Centers for Disease Control.1 Consistent with the NHSN,
abdominal surgeries are the foremost common reason for SSIs accounting for nearly
50%.2
3)
SSI manifests as induration and
redness of the incision site to discharge from the wound which could be of any nature from serous discharge to frank
pus. This can lead to problems ranging from superficial wound gape to complete dehiscence of the
abdominal wall at the site of wound closure. Depending on the grade of wound infection, it can lead to a
considerable financial strain on the health care facilities as well as on the patient owing to their prolonged hospital
stay, secondary dressing cost, readmission, loss of employment & disability.3
4)
A retrospective review of
hospital records by Wick et al. documented 30- and 90-day readmission rates for SSIs after CRS of 11.4 and
23.3% respectively, with a
median cost per event of $8885
USD.4
5)
A perioperative mortality
rate for SSI of 3 percent has been reported, with 75 percent of associated
deaths directly attributable to the SSI,5 its estimated that 60% of
those outcomes may be prevented with the increased use of evidence-based measures.6
6)
Studies show that the implementation of a five-part
bundle consisting of antibiotic
prophylaxis, hair removal before surgery, perioperative normothermia, perioperative euglycemia, and operating room discipline has decreased the incidence of SSI from 22% to 11%.7 7)
Following all additives of the
Bundle is challenging to comply with in an Emergency setting, subsequently raising the question of whether or not an
alternate of change of gloves before skin closure, being a far more feasible factor to comply with, can
lower the incidence of SSI and improve patients outcome.
8)
Abundant data have been obtained in the field of gynecology, urology & elective
surgeries but the information about surgical site infection in
Emergency abdominal surgeries seems to
be lacking. |