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CTRI Number  CTRI/2020/06/026207 [Registered on: 29/06/2020] Trial Registered Prospectively
Last Modified On: 26/06/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Single Arm Study 
Public Title of Study   Post Marketing clinical study on surgical wound dressing 
Scientific Title of Study   "An open label,comparative,post marketing study to evaluate the efficacy and safety of DRONAID dressing (activated charcoal absorption gauge) vs saline gauge used on surgical wound" 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Tushar 
Designation  Investigator 
Affiliation  AIIMS Bhubaneswar 
Address  AIIMS Bhubaneswar, Dept of Surgery sijua patrapad Bhubaneswar

Khordha
ORISSA
751019
India 
Phone    
Fax    
Email  surg_tushar@aiimsbhubaneswar.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Tushar 
Designation  Investigator 
Affiliation  AIIMS Bhubaneswar 
Address  AIIMS Bhubaneswar, Dept of Surgery sijua patrapad Bhubaneswar

Khordha
ORISSA
751019
India 
Phone    
Fax    
Email  surg_tushar@aiimsbhubaneswar.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Tuhin Chakraborthy 
Designation  co-investigator 
Affiliation  Clinopsys Clinical Research LLP 
Address  Clinopsys Clinical Research LLP No 9 Vinayaka Residency flat no 301, 3rd Floor RMV 2nd Stage 1st Main Dollars Colony

Bangalore
KARNATAKA
560094
India 
Phone    
Fax    
Email  tuhin.dr@gmail.com  
 
Source of Monetary or Material Support  
Neosatoria Bandages Pvt Limited Plot No 148, Ravi Colony,  
 
Primary Sponsor  
Name  Neosoteria Bandages Pvt Ltd 
Address  Neosoteria Bandages Pvt Ltd. Plot No 148, Ravi Colony, Trimulgherry Hyderabad,Telengana-500015, INDIA  
Type of Sponsor  Pharmaceutical industry-Indian 
 
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 Pankaj  AIIMS Bhubaneswar  AIIMS Bhubaneswar Sijua Patrapada Bhubaneswar
Khordha
ORISSA 		 9438884253

drpkushwaha@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  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  Carbon Surgical Bandages   DRONAID surgical wound dressing bandage is the medical device which will be used over the surgical wound as dressing material.The dressing will be applied till the wound is healed and evaluation will be performed as per the protocol on day day 3, Day 6 and Day 15 
Comparator Agent  Saline Gauge Dressing  Usual saline gauge dressing will be used as a comparator agent used over the surgical wound as dressing material.The dressing will be applied till tghe wound is healed and evaluation will be doe as per the protocol on Day 3, Day 6 and Day 15 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  i) Subjects who are ready to give voluntary written informed consent.
ii) Both Male and female subjects between the age group of 18-60years
iii) Subjects who undergone any major/ minor surgeries where the surgical wound need a dressing will be taken in to the study
 
 
ExclusionCriteria 
Details  i) Subjects allergic to charcoal
ii) Subjects who are unwilling to adhere to the study
iii) Individual has a condition the Investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results or put the person at undue risk
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
i) The primary objective of this pilot study is to assess the efficacy of DRONAID (activated charcoal absorption gauge) over surgical wound.

ii) Pain if any during the dressing change at day 15 		 i) The primary objective of this pilot study is to assess the efficacy of DRONAID (activated charcoal absorption gauge) over surgical wound at day 15

ii) Pain if any during the dressing change at day 15 
 
Secondary Outcome  
Outcome  TimePoints 
i) The secondary objective is to evaluate the time taken for complete wound healing   Day 3,Day 6 and Day 15 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   01/07/2020 
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="0"
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  

This open label post marketing study is proposed to be conducted to evaluate the efficacy and safety of DRONAID dressing (Activated Charcoal Absorption Gauge) as compared to Saline Gauge Dressing  on surgical wound 

 

The study protocol will be reviewed and approved by Institutional Ethics Committee prior to the initiation of the trial at the Investigator’s Site.

 50 subjects will be enrolled and randomized into two arms, in 1: 1 ratio. One arm will be getting Dronaid dressing and the other arm will be given Saline gauge. The subjects will be evaluated at the time of Inclusion in the study, subjects who undergo major/minor surgical procedures will be mainly included in the study. The subjects of both the gender between the age group of 18-60 yrs will be taken once they voluntarily sign the informed consent in front of the Principle Investigator.

Before applying the dressing over the wound, the wound will be evaluated by the Investigator as per the wound healing scale and if possible photograph will be taken as a baseline reading. Subjects Pain assessment will be conducted at the same time using VAS. At the baseline subjects vitals will also be recorded.

The subjects will be evaluated again at Day 3  for any adverse event or any complications. If the wound site or the dressing site shows any discharge the dressing will be changed as per the standardized norms and suitable measures will be taken as per the PI discretion.

The subjects will be subsequently recalled at Day 6 and the wound site will be evaluated by the Investigator the dressing will be re applied if the wound area requires so as per PI discretion

At Day 15 (End of Study) the subjects will be recalled and the wound site will be evaluated by the Investigator using wound healing scale and Pain will also be recorded using VAS.

 



 
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