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CTRI Number  CTRI/2025/03/083539 [Registered on: 26/03/2025] Trial Registered Prospectively
Last Modified On: 21/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Wound management]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To compare banana leaf dressing versus paraffin tulle gras dressing for the management of pemphigus vulgaris wounds 
Scientific Title of Study   Effectiveness of banana leaf dressing versus paraffin tulle gras dressing in the management of pemphigus vulgaris wounds: A pilot within-person randomized controlled, blinded outcome assessment 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 Win Subash Babu 
Designation  Junior resident 
Affiliation  Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Pondicherry 
Address  Department of Dermatology Jawaharlal Institute of Postgraduate Medical Education and Research Gorimedu, Dhanvantary nagar post ,Pondicherry

Pondicherry
PONDICHERRY
605006
India 
Phone  9894873328  
Fax  4132296000  
Email  winsubhashbabu@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Malathi Munisamy 
Designation  Additional Professor and Head 
Affiliation  Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Pondicherry 
Address  Department of Dermatology Jawaharlal Institute of Postgraduate Medical Education and Research Gorimedu, Dhanvantary nagar post ,Pondicherry

Pondicherry
PONDICHERRY
605006
India 
Phone  7373842888  
Fax  4132296000  
Email  mmalathi.dr@live.com  
 
Details of Contact Person
Public Query  
Name  Dr Malathi Munisamy 
Designation  Additional Professor and Head 
Affiliation  Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Pondicherry 
Address  Department of Dermatology Jawaharlal Institute of Postgraduate Medical Education and Research Gorimedu, Dhanvantary nagar post ,Pondicherry

Pondicherry
PONDICHERRY
605006
India 
Phone  7373842888  
Fax  4132296000  
Email  mmalathi.dr@live.com  
 
Source of Monetary or Material Support  
Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Pondicherry 605006 
 
Primary Sponsor  
Name  Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Pondicherry 
Address  JIPMER Dhanvantri Nagar Gorimedu Pondicherry -605006  
Type of Sponsor  Research institution and hospital 
 
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 Win Subash Babu  Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER)  Opd No -85 Room No :9 Department of Dermatology Pondicherry PONDICHERRY
Pondicherry
PONDICHERRY 		 9894873328
4132296000
winsubhashbabu@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE INTERVENTIONAL STUDIES  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L100||Pemphigus vulgaris,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  sterilized banana leaf dressing  Banana leaf after removing visible dirt and gentle wash, will be steam sterilised. The sterilised banana leaf will be directly applied to the wound, covered with gauze to prevent slippage. The dressing will be changed daily and will be applied till the wound is re-epithelialized for 3 weeks. 
Comparator Agent  sterilized paraffin tulle gras dressing   paraffin tulle gras dressing will be autoclaved. The sterilised paraffin tulle gras dressing will be directly applied to the wound, covered with gauze to prevent slippage. The dressing will be changed daily till wound healing for 3 weeks. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  85.00 Year(s)
Gender  Both 
Details  1.Consenting adult patients aged ≥ 18 years with active pemphigus vulgaris admitted in the der-matology wards
2.Patients with skin erosions involving ≥ 10% and ≤ 80% of the body surface area (BSA)
 
 
ExclusionCriteria 
Details  1.Patients with confluent erosions wherein dress-ings cannot be applied without carry-across ef-fect.
2.Patients in sepsis.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1.To assess the effectiveness of banana leaf dressings in comparison to paraffin tulle gras dressing on the wound healing as assessed by Bates-Jensen Wound Assessment Tool (BWAT) and Qualitative wound score (QWS) in patients with pemphigus vulgaris
2.To compare the time taken for achieving complete reepithelization between the two groups 		 Baseline, daily assessment 
 
Secondary Outcome  
Outcome  TimePoints 
1.To compare the wound healing as assessed based on infrared thermography between the two groups
2.To compare the pain associated with wound and pain associated with dressing change between the two groups 		 Baseline, daily assessment 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   15/04/2025 
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="2"
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   Pemphigus vulgaris is an autoimmune blistering disorder characterized by widespread blisters and painful moist erosions involving large body surface area causing significant discomfort and distress to the patients. These erosions also predispose to development of infections and worsens the disease activity. Hence local wound care with the appropriate dressings is an essential component in the management of pemphigus patients apart from immunosuppressive therapy. 
Banana leaves are an unlimited source of biomaterial and have a smooth and waxy surface that does not stick and has inherent wound healing properties as reported in various studies on burns, skin donor site wounds and facial traumatic wounds, making it a viable option in wound management resource poor settings.

While there are published trials proving the therapeutic benefits of banana leaf dressing in burns patients, donor sites of split thickness grafts and contused, lacerated and sutured wounds of head and neck area, there are no studies that have evaluated effectiveness of banana leaf dressing in the management of wounds in pemphigus vulgaris except for a single case report.

If banana leaf dressing is found to be effective in achieving adequate wound healing and alleviation of symptoms in pemphigus vulgaris when compared to the conventional paraffin tulle gras dressing, it can be incorporated in the routine management of pemphigus vulgaris which can reduce the need for high expenditure on dressing, especially in tropical countries where banana leaves are available in abundance.
 
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