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CTRI Number  CTRI/2020/02/023207 [Registered on: 10/02/2020] Trial Registered Prospectively
Last Modified On: 04/02/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Study to compare Collagen sheet dressing with Vaseline gauze dressing when used as a dressing material in sites from where skin graft is taken 
Scientific Title of Study   A randomized control trial comparing collagen sheet dressing with vaseline gauze dressing in assesing pain in split thickness skin graft donor site 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Chiran Bhakta Bista 
Designation  Resident , General Surgery 
Affiliation  Armed Forces Medical College, Pune 
Address  Department of surgery, Armed Forces Medical College, Wanowrie, Solapur road, near race course

Pune
MAHARASHTRA
411040
India 
Phone  8484866623  
Fax    
Email  cbista@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  S Tripathy 
Designation  Associate Professor, Senior Advisor General Surgery 
Affiliation  Armed Forces Medical College, Pune 
Address  Department of surgery, Armed Forces Medical College, Wanowrie, Solapur road, near race course

Pune
MAHARASHTRA
411040
India 
Phone  9623198357  
Fax    
Email  dr.stripathy@rediffmail.com  
 
Details of Contact Person
Public Query
 
Name  Chiran Bhakta Bista 
Designation  Resident, General Surgery 
Affiliation  Armed Forces Medical College,Pune 
Address  Department of surgery, Armed Forces Medical College, Wanowrie, Solapur road, near race course

Pune
MAHARASHTRA
411040
India 
Phone  8484866623  
Fax    
Email  cbista@gmail.com  
 
Source of Monetary or Material Support  
Armed Forces Medical College, Wanowrie, Solapur road, Pune,411040, Maharastra 
 
Primary Sponsor  
Name  Armed Forces Medical College 
Address  Department of surgery, Armed Forces Medical College, Wanowrie, Solapur road, near race course, Pune 
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 
Chiran Bhakta Bista  Armed Forces Medical College  Armed Forces Medical College,Surgical Division,Department of Surgery, Wanowrie, near race course
Pune
MAHARASHTRA 
8484866623

cbista@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethical committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L768||Other intraoperative and postprocedural complications of skin and subcutaneous tissue,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Collagen sheet dressing  Collagen sheet is a biological dressing derived from bovine source, comprising mostly type I and type III collagen which is retained in the tissue and gradually absorbed.It is also widely used in management of split thickness skin graft donor site wounds as a dressing material 
Comparator Agent  Vaseline gauze dressing  Vaseline gauze is a sterile, occlusive dressing consisting of fine mesh, absorbent gauze impregnated with approximately three times its weight of white petrolatum. It is widely used in management of burn wounds and split thickness skin graft donor site wounds.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  All patients who undergo split thickness skin graft surgery for any indication of the disease and can give consent on their own will be included 
 
ExclusionCriteria 
Details  1. Immunocompromised patients under cytotoxic drugs or steroids
2. Any scar at donor site 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare collagen sheet dressing and vaseline gauze dressing in assesing pain based on numerical pain rating scale on post operative days 01,07,14 and 21  days 01,07,14 and 21 
 
Secondary Outcome  
Outcome  TimePoints 
To compare days required for epithelialization with use of each dressing  Not applicable  
To compare the presence of surgical site infection with use of each dressing   Till the wound is completely healed and patient is under follow up 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   10/02/2020 
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 Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Split thickness skin grafting is a common reconstructive technique for the treatment of patients with deep burns and other traumatic injuries. Various types of dressing materials are available for the management of donor site after harvesting a split thickness skin graft such as semi permeable film dressings, semi permeable foam dressings, hydrogels, hydrocolloids, alginate dressings, bioactive wound dressings such as collagen, hyaluronic acid, chitosan and elastin or tissue engineered, medicated and composite dressings. Selection of an ideal dressing in such vast variety is a challenge. Thus, this study is aimed at most common presentation of the patient which is pain as primary outcome and similarly surgical site infection and time of epithelialization as secondary outcomes.

Vaseline gauze is a sterile, occlusive dressing consisting of fine mesh, absorbent gauze impregnated with approximately three times its weight of white petrolatum. 

Collagen sheet is a biological dressing derived from bovine source, comprising mostly type I and type III collagen which is retained in the tissue and gradually absorbed. 

Both dressings are commonly used and there is no ethical issue associated with their usage.

The primary objective of my study is to compare severity of pain with use of each dressing based on numerical pain rating scale where patient will rate the severity of his/her pain out of 10 (10 being most severe) on post-operative days 01, 07, 14 and 21. I have considered pain as primary objective because that is what the patient is most considered about. Similarly, my secondary objectives are to compare the number of days for epithelialization which is the number of days required for healing of the wound and presence or absence of surgical site infection. Thus, the study will also compare and analyze with usage of which dressing material the wound will heal faster and in which group surgical site infection is common.

 


 
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