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Comparing Outcomes for Prontosan Versus Normal Saline for Negative Pressure Wound Therapy With Instillation
NCT01939145 · View on ClinicalTrials.gov ↗
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. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Georgetown University, which has 109 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01939145 reports 1 study location spanning 1 distinct geographic area — top geographies include District of Columbia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01939145?
The interventions under investigation include: Normal saline (DRUG), Prontosan (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01939145?
This trial is sponsored by Georgetown University, which has 109 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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