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CTRI Number  CTRI/2024/10/075842 [Registered on: 24/10/2024] Trial Registered Prospectively
Last Modified On: 24/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Biological 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To study the healing capacity of Platelet Rich Plasma injection on skin wound in comparison with conventional dressing routinely used in the treatment of accidental wounds. 
Scientific Title of Study   Randomised Interventional study to evaluate the effectiveness of autologous PRP injection versus conventional Povidone Iodine dressing in the treatment of single acute post traumatic skin wound healing 
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 Riya Achuthan Unny 
Designation  MD Post Graduate student 
Affiliation  S N Medical College, Jodhpur. Rajasthan. 
Address  Blood Center, Mahatma Gandhi Hospital, Department Of Immunohematology and Transfusion Medicine, Dr. S N Medical College, Jodhpur.

Jodhpur
RAJASTHAN
342001
India 
Phone  9962648738  
Fax    
Email  drriyaunny@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rajshree Behra 
Designation  MD Pathology 
Affiliation  S N Medical College, Jodhpur. Rajasthan 
Address  The Head of department, Department of Immunohematology and Transfusion Medicine, Mahatma Gandhi Hospital, Jodhpur.

Jodhpur
RAJASTHAN
342001
India 
Phone  9828030210  
Fax    
Email  drrajshreebehra@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Rajshree Behra 
Designation  MD Pathology 
Affiliation  S N Medical College, Jodhpur. Rajasthan 
Address  The Head of department, Department of Immunohematology and Transfusion Medicine, Mahatma Gandhi Hospital, Jodhpur.

Jodhpur
RAJASTHAN
342001
India 
Phone  9828030210  
Fax    
Email  drrajshreebehra@gmail.com  
 
Source of Monetary or Material Support  
Mahatma Gandhi Hospital, Jodhpur. Rajasthan. India. 342001  
 
Primary Sponsor  
Name  Dr Riya Achuthan Unny 
Address  Department Of Immunohematology and Transfusion Medicine, Dr S N Medical College, Jodhpur. Rajasthan. India. 342003 
Type of Sponsor  Other [Self] 
 
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 Riya Achuthan Unny  Mahatma Gandhi Hospital  Plastic surgery ward, New building 2nd floor, Mahatma Gandhi Hospital, Jodhpur.342001
Jodhpur
RAJASTHAN 		 9962648738

drriyaunny@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee ,Dr. Sampurnanand Medical College, Jodhpur.  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Only healthy subjects whom admitted for acute post traumatic wound care 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Autologous Platelet Rich Plasma injection for post traumatic wound healing  Autologous Platelet Rich Plasma (2ml) prepared under aseptic condition and delivered to treating surgeon for infiltration on wound surface followed by non adhesive dressing. Done twice weekly till discharge. 
Comparator Agent  Povidone Iodine Dressing  Conventional Povidone iodine routine dressing done twice weekly till discharge 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Healthy subjects with accepted size of traumatic wound between 5-100sq.cm, admitted in ward for acute post traumatic wound management.  
 
ExclusionCriteria 
Details  Severe Anemic subjects, With low platelet count, With other co morbid illness, With H/o any chronic drug intake, with uncontrolled diabetes/pregnant and lactating women 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To compare the mean reduction in size of wound area(%) after treatment with PRP injection versus Povidone Iodine dressing in patients with acute post traumatic skin wound.  The primary outcome i.e Reduction in size of wound(area) is assessed at the end of 1st week, 2nd week and on the day of discharge. 
 
Secondary Outcome  
Outcome  TimePoints 
To observe the mean duration of hospital stay(in days)for subjects on treatment with PRP injection verses povidone Iodine dressing for acute post traumatic wound healing.   On the day of discharge. 
 
Target Sample Size   Total Sample Size="52"
Sample Size from India="52" 
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)   06/11/2024 
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="0"
Months="11"
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   Subjects admitted in Plastic surgery ward for the treatment of single acute post traumatic wound (otherwise healthy without co morbidities) are selected after wound debridement with consent from both the subjects and treating surgeon as per the inclusion and exclusion criteria. Study group(with PRP injection) /control group (povidone dressing) assigned as mentioned under randomization and allocation concealment method. Initial Ulcer area is recorded on day 0. Study subjects receive PRP Injection which is prepared by the PI and infiltrated in wound by the treating surgeon followed by non adhesive dressing done. Control subjects receive routine conventional povidone iodine dressing. Both these procedures done twice weekly. At the end of every week , size of wound area is noted as per treating surgeon advise. PUSH score of healing also recorded simultaneously. The initial wound area is considered as 100%. Thus the mean reduction in size of wound (area in %) at the end of every week is noted till discharge of both study and control subjects. 

Mean duration of hospital stay is calculated for both study and control subjects. 

Thus by comparing the rate of healing (% reduction in wound size) during the first/second  week by two different method of treatment helps to rejuvenate further upcoming treatment.

Platelet Rich Plasma (PRP) preparation: PRP is prepared only after treating surgeon consent by receiving 8.5 ml whole blood of study subject in Acid citrate vial. The procedure is done under specific standard operating procedure followed at Mahatma Gandhi hospital Blood Centre as per NABH standards.
 
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