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NCT01939145 · ClinicalTrials.gov registry record · Phase 4
Comparing Outcomes for Prontosan Versus Normal Saline for Negative Pressure Wound Therapy With Instillation
A Phase 4 study of Wound Infection, sponsored by Georgetown University.
- Completed
- Registry status
- Phase 4
- Development phase
- 100
- Enrollment target
- 1
- Study location
NCT01939145 is a Phase 4 study of Wound Infection that has completed, run by Georgetown University. The registered enrollment target is 100 participants, below the 368-participant average among 10 other Wound Infection trials with a reported enrollment target (73% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01939145, a Phase 4 study of Wound Infection, has completed, sponsored by Georgetown University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 100 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- DRUG Normal saline
- DEVICE Prontosan
Study Locations (1)
District of Columbia
- Medstar Georgetown University Hospital Center for Wound Healing - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2013-09 |
| Est. Completion | 2016-07 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01939145
The ClinicalTrials.gov registry entry for NCT01939145 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 368-participant average among 10 other Wound Infection trials with a reported enrollment target (73% lower). The listed sponsor is Georgetown University, which has 227 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Wound Infection appearing as the primary indexed condition, and to 2 interventions - of which Normal saline is the first listed.
NCT01939145 reports 1 study location spanning 1 distinct geographic area - top geographies include District of Columbia.
Frequently Asked Questions
What is clinical trial NCT01939145 about?
NCT01939145 is a clinical study titled "Comparing Outcomes for Prontosan Versus Normal Saline for Negative Pressure Wound Therapy With Instillation". 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 combinat...
What is the current status of trial NCT01939145?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 100 participants. The study started on 2013-09. Estimated completion is 2016-07.
What conditions does trial NCT01939145 study?
This clinical trial studies the following conditions: Wound Infection.
What interventions are being tested in trial NCT01939145?
The interventions under investigation include: Normal saline (DRUG), Prontosan (DEVICE).
Who is sponsoring clinical trial NCT01939145?
This trial is sponsored by Georgetown University, which has 227 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01939145 being conducted?
This trial has 1 study location across District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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