FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/08/093236 [Registered on: 19/08/2025] Trial Registered Prospectively
Last Modified On: 18/08/2025
Post Graduate Thesis  Yes 
Type of Trial  BA/BE 
Type of Study   Randomized control trial 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A study to compare two different solutions for peritoneal and wound wash in perforated appendicitis patients  
Scientific Title of Study   EFFECT OF SUPEROXIDIZED SOLUTION VERSUS NORMAL SALINE IN PERITONEAL AND WOUND LAVAGE AFTER OPEN APPENDECTOMY IN PERFORATED APPENDICITIS:A RANDOMIZED CONTROL TRIAL” 
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 Mamta Kumari 
Designation  Junior resident Surgery  
Affiliation  Indira Gandhi Medical College Shimla 
Address  Department of general surgery,IGMC Shimla

Shimla
HIMACHAL PRADESH
171001
India 
Phone  9805448633  
Fax    
Email  mamtasankhyan1810@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Puneet Mahajan 
Designation  Professor and head department of general surgery  
Affiliation  IGMC shimla 
Address  Department of general surgery IGMC shimla

Shimla
HIMACHAL PRADESH
171001
India 
Phone  9418151939  
Fax    
Email  puneetdr1@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Puneet Mahajan 
Designation  Professor and head department of general surgery  
Affiliation  IGMC shimla 
Address  Department of general surgery IGMC shimla

Shimla
HIMACHAL PRADESH
171001
India 
Phone  9418151939  
Fax    
Email  puneetdr1@gmail.com  
 
Source of Monetary or Material Support  
Nil 
 
Primary Sponsor  
Name  HIMCARE,AYUSHMAN BHARAT 
Address  IGMC SHIMLA  
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Mamta Kumari  IGMC Shimla  DEPARTMENT OF GENERAL SURGERY,IGMC Shimla
Shimla
HIMACHAL PRADESH 		 9805448633

mamtasankhyan1810@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ehics Committee IGMC Shimla  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K353||Acute appendicitis with localizedperitonitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Peritoneal and wound lovage with normal saline  Control group receive peritoneal and wound lavage with 0.9% saline 
Intervention  Superoxidized solution   Superoxidized solution contains hypochlorus acid (HOCl)0.003%,a chemical compound also generated by neutrophils as part of the body’s innate immunity.Superoxidized solution are neutral pH, hypotonic solutions with control amount of reactive species and low chlorine content.These reactive species exhibit extensive bactericidal activity. 
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1)Patient aged 6 years or above diagnosed with perforated appendicitis intraoperatively.
2) Patient underwent open appendectomy via Gridiron incision, midline incision , lanz in incision. 
 
ExclusionCriteria 
Details  1)Patient aged less than 6years .
2)Patient on steroids or immunosuppressant therapy were excluded.
3)Laparoscopic appendectomy
4) known allergy to any substance;
5) multiple trauma or organ injury;
• any gynecological etiology.
• patients who were not willing to include in the study or who did not complete the inclusion criteria were also excluded from the study. 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
to determine the effect of peritoneal and wound lavage with superoxidized solution in reducing surgical site infection following open appendectomy for perforated appendicitis  Postoperative day 1,3,5,30 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the duration of hospital stay  Postoperative day 1,3,5,30 
 
Target Sample Size   Total Sample Size="110"
Sample Size from India="110" 
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)   29/08/2025 
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)   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  
Perforated appendicitis carries a high risk of postoperative intra abdominal infection. This randomized controlled trial will compare the effect of peritoneal and wound lavage using superoxidized solution versus normal saline after open appendectomy in patients with perforated appendicitis. The primary objective is to evaluate differences in postoperative surgical site infection between the two groups. Secondary objectives include assessing length of hospital stay and overall morbidity.

 
Close