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
|
|
Primary Sponsor
|
Name |
CHRISTIAN MEDICAL COLLEGE |
Address |
CHRISTIAN MEDICAL COLLEGE VELLORE-632002 |
Type of Sponsor |
Private medical college |
|
Details of Secondary Sponsor
|
|
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
|
|
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 |