A STUDY COMPARING THE OUTCOME OF NEGATIVE PRESSURE WOUND THERAPHY WITH AND WITHOUT INSTILLATION.
- Conditions
- Fracture of bone following insertion of orthopedic implant, joint prosthesis, or bone plate,
- Registration Number
- CTRI/2019/09/021179
- Lead Sponsor
- CHRISTIAN MEDICAL COLLEGE
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 122
- Traumatic/atraumatic wounds which require flap cover 2.Wounds complicated by extensive biofilm/invasive infection 3.Diabetic wound infection.
- 4.Necrotizing fascitis.
- 1.Untreated osteomyelitis, necrotic tissue with eschar present 2.Malignancy wounds 3.Exposed blood vessels ,anastomotic sites 4.
- Patients at increased risk of bleeding.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Reduction in microorganisms. 30DAYS 3. Time to final procedure. 30DAYS 2. Reduction in surface area of wound. 30DAYS
- Secondary Outcome Measures
Name Time Method 1. Duration of hospital stay. 2. The proportion (percentage) of wounds that remained closed or covered approximately 30 days after hospital discharge.
Trial Locations
- Locations (1)
CHRISTIAN MEDICAL COLLEGE
🇮🇳Vellore, TAMIL NADU, India
CHRISTIAN MEDICAL COLLEGE🇮🇳Vellore, TAMIL NADU, IndiaDR CHANDRASEKARAN GPrincipal investigator7708892590chandras.guna@gmail.com