A Prospective Randomized Trial Comparing Outcomes for Prontosan Versus Normal Saline for Negative Pressure Wound Therapy With Instillation
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Georgetown University
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Number of Operating Room Visits
Study Overview
Brief Summary
This is a prospective, randomized trial comparing the outcomes for Prontosan versus normal saline as the solution for negative pressure wound therapy with instillation (NWPTi). Negative pressure wound therapy (NPWT) is a well established method of treatment for acute and chronic wounds. The combination of negative pressure with instillation of a solution is a relatively novel concept that has gained popularity and is currently used nationally and internationally. NPWTi is the standard of care for our division. Despite the growing use, there is limited information regarding the selection of the ideal instillation solution. This is a single site, investigator initiated, NPWTi study comparing the use of Prontosan with normal saline for the adjunctive treatment of the acutely infected wound that requires hospital admission. A total of 100 subjects will be included with 50 subjects in each treatment arm. The outcomes that will be measured are 1) number of operations, 2) length of hospital stay, 3) % of wounds closed prior to discharge, 4) time to closure prior to discharge, 5)% remained closed at 30 day follow-up, and 6) reduction of qualitative bacterial cultures. The results from this study will better characterize the most appropriate use of NPWTi.
Detailed Description
Overview This is a prospective, randomized, comparative trial examining 2 different instillation solutions for NPWTi. All wound types that meet the eligibility criteria will be enrolled into the study. After enrollment, subjects will be randomized into either the Prontosan NPWTi group (n=50) or the normal saline NPWTi group (n=50). Data will be collected from inpatient hospital records.
Outline of Study Procedures
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Patients meeting the eligibility criteria requiring hospital admission for an infected wound will be identified. Demographic information will be obtained.
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Informed consent will be obtained.
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Subjects will be taken to the operating room for wound debridement within 72 hours of admission per standard of care (SOC). Further, antibiotic therapy and medical management will be performed per SOC.
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Randomization into the Prontosan or normal saline instillation group will be conducted after the informed consent has been signed, but before the first operation.
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For the first operating room visit the following will be conducted:
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Pre- and post debridement qualitative cultures
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Debridement performed in SOC fashion
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Post debridement measurements
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Application of NPWTi
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For subsequent operating room visits the following will be conducted:
a. Pre- and post debridement qualitative cultures b. Debridement performed in SOC fashion c. Post debridement measurements d. Application of NPWTi or closure i. The decision to close the wound will be determined by the clinician per SOC.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Male or female greater than 18 years of age
- •Admission to the hospital for an infected wound
- •Diabetic, ischemic, neuropathic, venous, surgical wounds, any anatomical location
- •Subjects requiring serial (more than 1) operative debridement
Exclusion Criteria
- •Pregnancy
- •Patients with exposed bowel, brain matter, spinal cord
- •Patients with exposed peripheral bypass grafts
- •Known allergy or sensitivity to Prontosan or components of NPWT
- •Known allergy or sensitivity to adhesives
- •Uncontrolled bleeding disorders/coagulopathy
- •Wounds that tunnel to unexposed areas
- •Malignancy
Arms & Interventions
Normal Saline
The use of Normal Saline as the solution for Negative Pressure Wound Therapy with instillation.
Intervention: Normal saline (Drug)
Prontosan
The use of Prontosan as the solution in Negative Pressure Wound Therapy with Instillation.
Intervention: Prontosan (Device)
Outcomes
Primary Outcomes
Number of Operating Room Visits
Time Frame: Patients will be followed during their hospital stay which is an average of approximately 2 weeks.
Compare the number of operative room visits between Prontosan NPWTi and normal saline NPWTi.
Secondary Outcomes
- Hospital Admission Length of Stay(Patients will be followed during their hospital stay which is an average of approximately 2 weeks.)
Investigators
Paul J. Kim, DPM
Principal Investigator
Georgetown University