| CTRI Number |
CTRI/2026/01/101644 [Registered on: 20/01/2026] Trial Registered Prospectively |
| Last Modified On: |
19/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Probiotic |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Use of Probiotics to Reduce Infection and Improve Healing in Chronic Wounds |
|
Scientific Title of Study
|
Effect of Topical Probiotics on Biofilm producing Bacteria in Chronic Wounds: 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 |
Akshay Kapoor |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences Rishikesh |
| Address |
Department of Burns & Plastic Surgery
6th Floor, Block A
AIIMS Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
|
| Fax |
|
| Email |
akshay.7884@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Akshay Kapoor |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences Rishikesh |
| Address |
Department of Burns & Plastic Surgery
6Th Floor, Block A
AIIMS Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
|
| Fax |
|
| Email |
akshay.7884@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Akshay Kapoor |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences Rishikesh |
| Address |
Department of Burns & Plastic Surgery
6th Floor Block A
AIIMS Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
|
| Fax |
|
| Email |
akshay.7884@gmail.com |
|
|
Source of Monetary or Material Support
|
| Medical Research Unit of All India Institute of Medical
Sciences- Rishikesh
2nd Floor, Block A, AIIMS Rishikesh
Pin code 249203, Dehradun, India |
|
|
Primary Sponsor
|
| Name |
MRU AIIMS Rishikesh |
| Address |
2nd Floor, Block A, AIIMS Rishikesh
Veerbhadra Road
Pin code 249203,
Dehradun,
India |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Akshay Kapoor |
All India Institute of Medical Sciences Rishikesh |
Department of Plastic Surgery
6th Floor Block A
Room 016612
Dehradun
UTTARANCHAL |
7044055650
akshay.7884@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Comittee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L088||Other specified local infections of the skin and subcutaneous tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Psyllium Husk Powder |
Since Psyllium husk powder is an inert agent, it will be used as a placebo and appears similar to probiotic powder. It will be added to dressing along with the standard of care. The dressing will be changed every other day for 2 weeks. Wound cultures will be assessed at 2-week intervals for up to 6 weeks. This means a patient may receive a total of 21 dressing changes |
| Intervention |
Topical Probiotic |
Probiotic powder will be applied to a chronic non-healing ulcer along with standard of care treatment. The dressing will be changed every other day for 2 weeks. Wound cultures will be assessed at 2-week intervals for a maximum of 6 weeks. This means a patient may receive a total of 21 dressing changes. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1)Patients coming to the OPD and IPD of surgical departments of AIIMS Rishikesh with chronic wounds (wounds that are not able to heal by 4 weeks
2)Wounds greater than 5 cm in both dimensions which will require skin graft
3)Patients willing to come to the OPD once every 2 weeks week
|
|
| ExclusionCriteria |
| Details |
1) Patients with AIDS
2) Patients who have had transplant surgery,
3) Patients with Peripheral Vascular Disease,
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Evaluation of wound cultures for biofilm presence and microbial growth will be performed at the end of 2 weeks of therapy. Therefore, a total of 3 wound cultures will be taken |
2 weeks, 4 weeks, and 6 weeks after initiation of therapy |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Graft survival |
4 weeks after skin grafting |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
30/01/2026 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Aim: -To evaluate the reduction of biofilm-producing bacteria and subsequent healing in chronic wounds in the presence of topical probiotics
Objectives
- Evaluation of wound cultures of intervention arm and control arm at 2 week intervals for upto 6 weeks
2. Evaluate graft success rate in the intervention and control arm 3. Evaluate the emergence of ESBL resistance in both groups
Project Implementation Plan Using purposive sampling we will identify the patients eligible for inclusion into the study as per the given criteria. Then using a computer-generated random number sequence, the patients will be allotted to the control and intervention group. Control- The standard treatment, which consists of wound debridement followed by dressing with Bactigras and Nanosilver ointment. Intervention – Application of topical probiotic along with standard treatment. |
Statistical analysis 1) Comparison of difference in wound culture for biofilm causing bacteria between two arms at 6 weeks using chi square test 2) Comparison of proportion between the two arms who are graft ready at 6 weeks using 3) Comparison of proportions between two arms who have achieved favourable graft uptake ( >80%) |
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