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CTRI Number  CTRI/2015/01/005419 [Registered on: 16/01/2015] Trial Registered Retrospectively
Last Modified On: 14/01/2015
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Process of Care Changes 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A clinical trial to study the effects of two types of dressing, Limited access dressing and conventional dressing in patients with Non healing chronic ulcers. 
Scientific Title of Study   HISTOLOGICAL AND BIOCHEMICAL STUDY OF GRANULATION TISSUE MODULATED BY NEGATIVE PRESSURE UNDER LAD 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Honnegowda 
Designation  Research scholar 
Affiliation  Kasturba medical college manipal 
Address  Department of Plastic Surgery and Burns Kasturba medical college Manipal University Manipal

Udupi
KARNATAKA
576104
India 
Phone  8453881779  
Fax    
Email  honnegowda33@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Pramod kumar 
Designation  Prof and Head  
Affiliation  Kasturba medical college manipal 
Address  Department of Plastic Surgery and Burns Kasturba medical college Manipal University Manipal

Udupi
KARNATAKA
576104
India 
Phone  9901700052  
Fax    
Email  pkumar86@hotmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Pramod kumar 
Designation  Prof and Head  
Affiliation  Kasturba medical college manipal 
Address  Department of Plastic Surgery and Burns Kasturba medical college Manipal University Manipal

Udupi
KARNATAKA
576104
India 
Phone  9901700052  
Fax    
Email  pkumar86@hotmail.com  
 
Source of Monetary or Material Support  
None 
 
Primary Sponsor  
Name  Manipal univeristy 
Address  Manipal university, Manipal india 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
None  None 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Honnegowda  Plastic surgery and burns ward  kasturba hospital
Udupi
KARNATAKA 		 8453881779

honnegowda33@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Non healing chronic ulcers,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional dressing   Wounds were washed with saline before dressing.Dressing will be changed every alternative day. The treatment process continue until wound heal. 
Intervention  Limited access dressing   Negative pressure wound therapy and moist wound healing. Each LAD dressing can keep upto 10-15 days and Wounds were washed with saline daily through the ports which access into LAD dressing. The treatment process continue until wound heal. 
 
Inclusion Criteria  
Age From  12.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Non diabetic chronic ulcers 
 
ExclusionCriteria 
Details  Patients with collagen disorders, Leprosy patients, Pregnant women, Liver cirrhosis, HIV +ve patients.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Collagen content (Hydroxyproline) in the granulation tissue  After 10 days of treatment  
 
Secondary Outcome  
Outcome  TimePoints 
hexosamine, total protein, and antioxidants [reduced glutathione (GSH), glutathione peroxidase (GPx), glutathione s-transferase (GST), catalase (CAT), thiol], wound surface pH, matrix metalloproteinase-2 (MMP-2), and oxidative biomarker malondialdhyde (MDA) were measured in the granulation tissue. Histopathologically, necrotic tissue, amount of inflammatory infiltrate, angiogenesis and extracellular matrix deposition (ECM) were studied to determine wound healing.  After 10 days of treatment 
 
Target Sample Size   Total Sample Size="84"
Sample Size from India="84" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/01/2012 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="3"
Months="4"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Review articles- 1. Kumar P, Honnegowda TM, Udupa EG, Rao P, Saran A, Bhandari S. The role of matrix metalloproteinase in the chronic wound healing. J Soc Wound Care Search 2012;5:7-16. 2. Kumar P, Honnegowda TM, Udupa EG, Rao P. The role of Nitric oxide in chronic and acute wound healing. J Soc Wound Care Search 2013; 6(1):14-23. Original article Honnegowda, Kumar P, Udupa P et al. Effect of limited access dressing on hydroxyproline and enzymatic antioxidant status in nonhealing chronic ulcers. Indian J Plast Surg. 2014; 47(2): 216-20.  
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

The primary outcome measures will be level of hydroxyproline in the wound granulation tissue.The secondary outcomes were hexosamine, total protein, and antioxidants [reduced glutathione (GSH), glutathione peroxidase (GPx), glutathione s-transferase (GST), catalase (CAT), thiol], wound surface pH, matrix metalloproteinase-2 (MMP-2), and oxidative biomarker malondialdhyde (MDA) were measured in the granulation tissue. Histopathologically, necrotic tissue, amount of inflammatory infiltrate, angiogenesis and extracellular matrix deposition (ECM) were studied to determine wound healing.

 

 
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