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CTRI Number  CTRI/2025/11/097471 [Registered on: 14/11/2025] Trial Registered Prospectively
Last Modified On: 14/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   To compare efficacy of different types of dressings and no dressing for treatment lower limb cellulitis 
Scientific Title of Study   A randomized control trial to compare clinical efficacy of glycerine cotton crepe dressing, magnesium sulphate dressing and no dressing among patients suffering from lower limb cellulitis in a tertiary care hospital in Pune 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shrey Kansal 
Designation  Junior Resident, Department of General Surgery 
Affiliation  Armed Forces Medical College, Pune  
Address  Department of Surgery, Armed Forces Medical College, Wanowrie, Pune, Maharashtra Pin Code- 411040
Armed Forces Medical College, Wanowrie, Pune, Maharashtra Pin Code- 411040
Pune
MAHARASHTRA
411040
India 
Phone  9739570686  
Fax    
Email  kansal.shrey23@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Anurakshat Gupta  
Designation  Professor, Department of General Surgery 
Affiliation  Armed Forces Medical College, Pune  
Address  Department of Surgery, Armed Forces Medical College, Wanowrie, Pune, Maharashtra Pin Code- 411040
Armed Forces Medical College, Wanowrie, Pune, Maharashtra Pin Code- 411040
Pune
MAHARASHTRA
411040
India 
Phone  9765984477  
Fax    
Email  anurakshat@rediffmail.com  
 
Details of Contact Person
Public Query  
Name  Shrey Kansal 
Designation  Junior Resident, Department of General Surgery 
Affiliation  Armed Forces Medical College, Pune  
Address  Department of Surgery, Armed Forces Medical College, Wanowrie, Pune, Maharashtra Pin Code- 411040
Armed Forces Medical College, Wanowrie, Pune, Maharashtra Pin Code- 411040
Pune
MAHARASHTRA
411040
India 
Phone  9739570686  
Fax    
Email  kansal.shrey23@gmail.com  
 
Source of Monetary or Material Support  
Armed Forces Medical College, Banwari, Pune, Maharashtra, India Pin Code- 411040 
 
Primary Sponsor  
Name  Armed Forces Medical College , Pune 
Address  Armed Forces Medical College, Wanowrie, Pune, Maharashtra Pin Code- 411040 
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 
Shrey Kansal   Command Hospital, Southern Command   Acute Surgery Ward/Female Surgery Ward/Civil Male Ward/Civil Female Ward/ Civil Surgery OPD/ Surgery Service OPD Department of Surgery, Surgical Div, Pune Cantonment, Pune, Maharashtra Pin- 411040
Pune
MAHARASHTRA 		 9739570686

kansal.shrey23@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Medical Research Cell and Institutional Ethical Committee, Armed Forces Medical College, Pune  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Glycerine Cotton Crepe Dressing   Dressing of affected limb with glycerine cotton crepe dressing Duration- 48 to 144 hours 
Intervention  Magnesium Sulphate Dressing   Dressing of affected limb with magneisum suplhate dressing Duration- 48 to 144 hours 
Comparator Agent  No dressing   No dressing applied on affected limb Duration: 48 to 144 hours 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Adults diagnosed with lower limb cellulitis seeking medical attention. 
 
ExclusionCriteria 
Details  1) Know allergy to dressing component/s used in the study.
2) Refusal to participate in the study
3) Patients suffering from malignant diseases.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To compare the clinical outcome of magnesium sulphate, glycerine cotton crepe and no dressing with respect to decrease in pain, erythema, oedema and glistening of skin in patients suffering from lower limb cellulitis.   48hrs, 96hrs, 140hrs 
 
Secondary Outcome  
Outcome  TimePoints 
To estimate and incidence of appearance of blisters and development of burning sensation in patients suffering from lower limb cellulitis managed with magnesium sulphate and glycerine dressings.   48hrs, 96hrs, 140hrs  
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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)   25/11/2025 
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 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   This randomized controlled trial will compare the clinical efficacy of glycerine dressing, magnesium sulphate dressing and no dressing in adults with lower limb cellulitis. Cellulitis is a common inflammatory condition of skin and soft tissue and there is no clear consensus on the optimal dressing method. Glycerine has hygroscopic properties and magnesium sulphate is believed to have anti inflammatory effects but evidence for their benefit over no dressing is limited. Ninety adult patients with lower limb cellulitis will be randomly allocated to three groups of thirty each. All groups will receive standard treatment with intravenous antibiotics analgesics and limb elevation. The primary outcomes are reduction in pain erythema edema and glistening of skin. Secondary outcomes include appearance of blisters and burning sensation. Assessments will be done on day three day five and day seven. The study is a pilot trial conducted at a tertiary care hospital in Western Maharashtra over eighteen months. The findings are expected to provide evidence to guide optimal dressing strategy in lower limb cellulitis. 
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