| CTRI Number |
CTRI/2025/11/097794 [Registered on: 20/11/2025] Trial Registered Prospectively |
| Last Modified On: |
20/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Preventive |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of two commonly used antiseptic solutions (alcohol-based vs. povidone-iodine) to prevent wound infections after surgery. |
|
Scientific Title of Study
|
A Prospective, Randomized Controlled Trial Comparing 2 Propanol plus Benzalkonium Chloride versus Povidone Iodine for the Prevention of Surgical Site Infections |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sameer Uttamrao Khasbage |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
AIIMS, RAIPUR |
| Address |
Room No. 2221, Department, Of Pharmacology, 2nd Floor
Medical College Building, Gate, 5, Aiiims Raipur
Raipur
CHHATTISGARH
492099
India |
| Phone |
9579502670 |
| Fax |
|
| Email |
samkhasbage@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sameer Uttamrao Khasbage |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
AIIMS, RAIPUR |
| Address |
Room No. 2221, Department, Of Pharmacology, 2nd Floor
Medical College Building, Gate, 5, Aiiims Raipur
Raipur
CHHATTISGARH
492099
India |
| Phone |
9579502670 |
| Fax |
|
| Email |
samkhasbage@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sameer Uttamrao Khasbage |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
AIIMS, RAIPUR |
| Address |
Room No. 2221, Department, Of Pharmacology, 2nd Floor
Medical College Building, Gate, 5, Aiiims Raipur
Raipur
CHHATTISGARH
492099
India |
| Phone |
9579502670 |
| Fax |
|
| Email |
samkhasbage@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences Raipur, Chhattisgarh, India,
Gate No 5, Great Eastern Rd, AIIMS Campus, Tatibandh, Raipur, Chhattisgarh, India 492099 |
|
|
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 Sameer Uttamrao Khasbage |
All India Institute of Medical Sciences, Raipur(Chhattisgarh) |
Department of Pharmacology and Surgery, Room No.2221, Gate no.5, All India Institute of Medical Sciences Raipur, 492099
Raipur
CHHATTISGARH |
9579502670
samkhasbage@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institute Ethics Committee, All India Institute of Medical Sciences, Raipur (Chhattisgarh) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: B998||Other infectious disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Arm A (Experimental): 2-propanol 70% + Benzalkonium chloride 0.13%. |
Arm A (Experimental): 2-propanol 70% + Benzalkonium chloride 0.13%., applied twice pre-op with drying time of 2 minutes. |
| Comparator Agent |
Arm B (Comparator): Povidone-iodine 10% solution. |
Arm B (Comparator): Povidone-iodine 10% solution, applied once as per standard protocol. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion criteria (18 years, clean/clean-contaminated elective surgeries, ASA I–III) |
|
| ExclusionCriteria |
| Details |
Exclusion criteria (allergy, emergency surgery, immunocompromised, pregnancy/lactation, neonates) |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of SSI within 30 days post-surgery, defined by CDC criteria. |
Incidence of surgical site infection at postoperative day 7, day 14, day 30. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Time to onset of SSI |
From day of surgery to postoperative day 30. |
| Classification of SSI |
Time Point: Day 7, Day 14, Day 30. |
| Local skin reactions |
Day 0, Day 1, Day 7, Day 14. |
| Adverse events |
Day 0 to Day 30. |
| Cost-effectiveness |
At end of follow-up (Day 30). |
|
|
Target Sample Size
|
Total Sample Size="434"
Sample Size from India="434"
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)
|
01/12/2025 |
| 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="6"
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 among the most common complications after surgery, leading to prolonged hospital stay, higher costs, and increased patient suffering. Preoperative skin antisepsis is a key step in preventing these infections. In India, povidone-iodine is widely used, but international guidelines now recommend alcohol-based antiseptics for faster and longer-lasting protection. This study will compare the effectiveness of an alcohol-based antiseptic (2-propanol with benzalkonium chloride) against povidone-iodine in reducing surgical site infections.
We will include 434 adult patients undergoing clean or clean-contaminated elective surgeries at AIIMS Raipur. Patients will be randomly assigned to receive either the alcohol-based antiseptic or povidone-iodine before surgery. All other aspects of surgery and post-operative care will remain the same. The main outcome will be the occurrence of surgical site infection within 30 days after surgery. The findings may help develop locally relevant antiseptic guidelines and improve infection control practices. |