| CTRI Number |
CTRI/2024/12/078118 [Registered on: 16/12/2024] Trial Registered Prospectively |
| Last Modified On: |
15/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Peritoneal lavage with hypochlorous acid( 50 ppm )] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Evaluating the effectiveness of hypochlorous acid in preventing surgical site infections: A randomised controlled trial in perforation peritonitis patients |
|
Scientific Title of Study
|
Prospective randomised controlled study to evaluate the effectiveness of hypochlorous acid as a peritoneal lavage agent to prevent surgical site infection after exploratory laparotomy for perforation peritonitis |
| 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 ARUN KUMAR |
| Designation |
Junior Resident |
| Affiliation |
Moti Lal Nehru Medical College, Prayagraj |
| Address |
Department of General Surgery, Moti Lal Nehru Medical College Prayagraj
Allahabad
UTTAR PRADESH
211002
India |
| Phone |
8960637352 |
| Fax |
|
| Email |
Arunkr272@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mayank Singh |
| Designation |
Professor |
| Affiliation |
Moti Lal Nehru Medical College, Prayagraj |
| Address |
Department of General Surgery, Moti Lal Nehru Medical College Prayagraj
Allahabad
UTTAR PRADESH
211002
India |
| Phone |
9005965779 |
| Fax |
|
| Email |
Dr.mayanksingh78@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mayank Singh |
| Designation |
Professor |
| Affiliation |
Moti Lal Nehru Medical College, Prayagraj |
| Address |
Department of General Surgery, Moti Lal Nehru Medical College Prayagraj
Allahabad
UTTAR PRADESH
211002
India |
| Phone |
9005965779 |
| Fax |
|
| Email |
Dr.mayanksingh78@gmail.com |
|
|
Source of Monetary or Material Support
|
| Moti Lal Nehru Medical College, Prayagraj, UttarPradesh, India 211002 |
|
|
Primary Sponsor
|
| Name |
Dr Arun Kumar |
| Address |
Moti Lal Nehru Medical College, Prayagraj, UttarPradesh, India 211002 |
| Type of Sponsor |
Other [Self] |
|
|
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 Arun Kumar |
SWAROOP RANI NEHRU HOSPITAL |
Department of General Surgery/General Surgery/Emergency General Surgery OT
Allahabad
UTTAR PRADESH |
8960637352
arunkr272@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee MLN MEDICAL COLLEGE and associate hospitals Prayagraj |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K631||Perforation of intestine (nontraumatic), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Peritoneal lavage with hypochlorous acid (50ppm) |
2000 ml of 50ppm hypochlorous acid will be used for peritoneal lavage and 500 ml of 50ppm hypochlorous acid will used to irrigate wound site after rectus sheath closure |
| Comparator Agent |
Peritoneal lavage with normal saline( 0.9%) |
2000 ml of normal saline 0.9 % will be used for peritoneal lavage and 500 ml
Of normal saline 0.9% will used to irrigate wound site after rectus sheath closure |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Dirty wound (class- IV)according to CDC classification. • Emergency surgery by midline or transverse laparotomy for perforation peritonitis . • Age ≥ 18 years. • American society of anaesthesiologists (ASA) score ≤ 3. • Ability to understand the nature and extent of the study and to give written informed consent. |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the efficacy of HOCl ( Hypochlorous acid) versus normal saline in perforation peritonitis cases in view of superficial and deep incisional SSI. |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine the safety profile of HOCI in peritoneal lavage. |
30 days |
|
|
Target Sample Size
|
Total Sample Size="144"
Sample Size from India="144"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
26/12/2024 |
| 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="9"
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
|
Surgical site infections (SSIs) are a frequent and serious complication
following abdominal surgeries, contributing to increased morbidity,
extended hospital stays and higher healthcare costs. Patients undergoing
exploratory laparotomy for perforation peritonitis face a heightened risk of
SSIs due to contamination of the peritoneal cavity by gastrointestinal
contents. One method to mitigate this risk is to lavage the intraperitoneal
cavity. Hypochlorous acid, recognized for its broad-spectrum antimicrobial
activity, biocompatibility, and potential to reduce infection rates, represents
a promising antiseptic. Utilizing it as a peritoneal lavage agent is an
innovative strategy that could yield better outcomes than traditional
methods. Conducting a randomized controlled trial (RCT) will offer robust
evidence on the efficacy and safety of hypochlorous acid in preventing SSIs.
Demonstrating its effectiveness can directly enhance patient recovery times,
alleviate pain and discomfort, and improve overall post-surgery quality of life.
By potentially reducing the incidence of SSIs, the study can also promote
more cost-effective healthcare by decreasing the need for extended
treatments and readmissions. Positive outcomes could influence surgical
protocols and guidelines, supporting the integration of hypochlorous acid
into clinical practice. Additionally, the findings could pave the way for further
research into other uses of hypochlorous acid across various surgical and
wound care contexts. Addressing SSIs, a prevalent public health issue, the
study can contribute to better health outcomes and reduce the healthcare
system’s burden. |