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CTRI Number  CTRI/2019/09/021179 [Registered on: 11/09/2019] Trial Registered Prospectively
Last Modified On: 09/09/2019
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A STUDY COMPARING THE OUTCOME OF NEGATIVE PRESSURE WOUND THERAPHY WITH AND WITHOUT INSTILLATION. 
Scientific Title of Study   RANDOMISED CONTROL TRIAL COMPARING THE EFFICACY OF STANDARD NEGATIVE PRESSURE WOUND THERAPHY WITH NEGATIVE PRESSURE WOUND THERAPHY WITH INSTILLATION. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR CHANDRASEKARAN G 
Designation  ASSISTANT PROFESSOR  
Affiliation  CHRISTIAN MEDICAL COLLEGE VELLORE 
Address  DEPARTMENT OF ORTHOPAEDICS UNIT III PAUL BRAND BUILDING CHRISTIAN MEDICAL COLLEGE TAMILNADU INDIA PHONE No 04162282091
DEPARTMENT OF ORTHOPAEDICS UNIT III PAUL BRAND BUILDING CHRISTIAN MEDICAL COLLEGE TAMILNADU INDIA PHONE No 04162282091
Vellore
TAMIL NADU
632002
India 
Phone  04162282091  
Fax  04162282035  
Email  chandras.guna@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR CHANDRASEKARAN G 
Designation  ASSISTANT PROFESSOR  
Affiliation  CHRISTIAN MEDICAL COLLEGE VELLORE 
Address  DEPARTMENT OF ORTHOPAEDICS UNIT III PAUL BRAND BUILDING CMC VELLORE TAMILNADU INDIA PHONE No 04162282091
DEPARTMENT OF ORTHOPAEDICS UNIT III PAUL BRAND BUILDING CHRISTIAN MEDICAL COLLEGE TAMILNADU INDIA PHONE No 04162282091
Vellore
TAMIL NADU
632002
India 
Phone  04162282091  
Fax  04162282035  
Email  chandras.guna@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DR CHANDRASEKARAN G 
Designation  ASSISTANT PROFESSOR  
Affiliation  CHRISTIAN MEDICAL COLLEGE VELLORE 
Address  DEPARTMENT OF ORTHOPAEDICS UNIT III PAUL BRAND BUILDING CMC VELLORE TAMILNADU INDIA PHONE No 04162282091
DEPARTMENT OF ORTHOPAEDICS UNIT III PAUL BRAND BUILDING CHRISTIAN MEDICAL COLLEGE TAMILNADU INDIA PHONE No 04162282091
Vellore
TAMIL NADU
632002
India 
Phone  04162282091  
Fax  04162282035  
Email  chandras.guna@gmail.com  
 
Source of Monetary or Material Support  
nil 
 
Primary Sponsor  
Name  CHRISTIAN MEDICAL COLLEGE  
Address  CHRISTIAN MEDICAL COLLEGE VELLORE-632002 
Type of Sponsor  Private 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 
DR CHANDRASEKARAN G   CHRISTIAN MEDICAL COLLEGE  DEPARTMENT OF ORTHOPAEDICS UNIT III PAUL BRAND BUILDING
Vellore
TAMIL NADU 
7708892590
04162282035
chandras.guna@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
OFFICE OF RESEARCH IRB CMC VELLORE INDIA   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M966||Fracture of bone following insertion of orthopedic implant, joint prosthesis, or bone plate,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  standard negative pressure wound theraphy with and with out instillation   NEGATIVE PRESSURE WOUND THERAPY IS APPLIED DIRECTLY OVER THE WOUND WITH CONTINUOUS PRESSURE OF -125 mm Hg for a period of 3 days and wound was inspected . 
Comparator Agent  standard negative pressure wound therapy with instillation   Normal saline(0.9%) briefly instilled into the wound and allowed to diffuse for 10-20 minutes followed by 2- hours of negative pressure at -125 mmHg for a period of 2-3 days and wound was inpected. 
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Traumatic/atraumatic wounds which require flap cover
2. Wounds complicated by extensive biofilm/invasive infection
3. Diabetic wound infection.
4. Necrotizing fascitis.

 
 
ExclusionCriteria 
Details  1. Untreated osteomyelitis, necrotic tissue with eschar present
2. Malignancy wounds
3. Exposed blood vessels ,anastomotic sites
4. Patients at increased risk of bleeding
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Reduction in microorganisms.
2. Reduction in surface area of wound.
3. Time to final procedure.
 
30DAYS 
 
Secondary Outcome  
Outcome  TimePoints 
1. Duration of hospital stay.
2. The proportion (percentage) of wounds that remained closed or covered approximately 30 days after hospital discharge.
 
30 DAYS 
 
Target Sample Size   Total Sample Size="122"
Sample Size from India="122" 
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)   01/10/2019 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   1.WOUND JOURNAL 2.JOURNAL OF BONE AND JOINT SURGERY  
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Negative Pressure wound therapy with instillation provides an additional dimension with the ability to deliver a solution to the wound bed in a preprogrammed manner. The goal of wound management is to create an environment that is conductive to wound healing by decreasing the bacterial bio burden and improving perfusion to the wound. NPWT instillation combines NPWT and timed delivery of topical irrigation solutions. The addition of an instilled irrigating fluid to NPWT provides a unique autolytic and mechanical debridement effect that appears to enhance wound healing over our traditional standard of care for these complex, infected wounds. To test the benefits of antimicrobial instillation in conjunction with NPWT, RCT study was designed to explore the use of VAC therapy plus the intermittent delivery of an instilled antimicrobial topical solution and its effectiveness in treating complex, infected wounds. The reduction in microorganisms, days to wound closure and reduction in surface area of wound were established as endpoints that would best measure the effectiveness of NPWT instillation therapy. It was hypothesized that enhanced reduction in bacterial bio burden would lead to quicker wound closure and patient discharge, resulting in hospital cost savings and reduced patient expense

 
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