Effect of Topical Probiotics on Biofilm producing Bacteria in Chronic Wounds: A Randomized Control Trial
Trial Snapshot
- Phase
- Phase 3 4
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 42
- Locations
- 1
- Primary Endpoint
- 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
Study Overview
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
-
Evaluate graft success rate in the intervention and control arm
-
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.
A baseline culture of the wound will be taken from the wound at the time of patient enrolment. The patients will be trained for dressing and will perform dressing every alternate day and will follow up in the OPD every 2 weeks where he will be provided with the dressing kit. At the end of 4 weeks the patient will be evaluated for readiness of grafting and wound healing. Patients ready for grafting would be taken up for surgery and graft success reported by percentage uptake at 2 weeks post-surgery.
| 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%)
Baseline table of time taken for graft readiness and number of patients healed (%, Mean (SD), Median (IQR
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant and Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 75.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •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.
Exclusion Criteria
- •Patients with AIDS 2) Patients who have had transplant surgery, 3) Patients with Peripheral Vascular Disease,.
Outcomes
Primary Outcomes
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
Time Frame: 2 weeks, 4 weeks, and 6 weeks after initiation of therapy
Secondary Outcomes
- Graft survival(4 weeks after skin grafting)
Investigators
Akshay Kapoor
All India Institute of Medical Sciences Rishikesh