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NCT02509260 · ClinicalTrials.gov registry record · NA
Prevena™ Incisional Negative Pressure Wound Therapy in Re-operative Colorectal Surgery
A NA study of Surgical Site Infection, sponsored by The Cleveland Clinic.
- Completed
- Registry status
- NA
- Development phase
- 298
- Enrollment target
- 1
- Study location
NCT02509260 is a NA study of Surgical Site Infection that has completed, run by The Cleveland Clinic. The registered enrollment target is 298 participants, below the 557-participant average among 25 other Surgical Site Infection trials with a reported enrollment target (46% lower). The trial reports 1 study location across 1 state.
The verdict
NCT02509260, a NA study of Surgical Site Infection, has completed, sponsored by The Cleveland Clinic.
- COMPLETED
- Registry status
- NA
- Development phase
- 298 participants
- Enrollment target
- 1
- Study location
Study Summary
Many strategies have been attempted to reduce SSI rates. The Centers for Medicare and Medicaid Services introduced the Surgical Care Improvement Project infection project with the aim of reducing SSI incidence and morbidity. These measures include prophylactic intravenous antibiotics administered within 1 hour of skin incision, appropriate prophylactic antibiotic selection, discontinuation of prophylactic antibiotics within 24 hours after surgery, appropriate hair removal, and maintenance of perioperative normothermia. Despite the enforcement of these measures through quality reporting and pay-for-performance measures, significant controversy exists as to their overall effectiveness, especially in the high-risk colorectal surgical population. Laparoscopic surgery has been shown to improve SSI rates in the colorectal population; however, not all patients are appropriate candidates for this approach and the inability of promising interventions such as wound edge protection and gentamicin sponges to improve SSI rates following colorectal surgery mandate the investigation of novel techniques. The aim of the current study is to assess the clinical effectiveness of incisional NPWT to reduce SSI rates in open, re-operative colorectal surgery. The primary endpoint of this study is the occurrence of superficial SSI within 30 days after surgery and the secondary endpoints include length of hospital stay and cost effectiveness.
Conditions Studied
Interventions
- DEVICE Prevena wound management system
- OTHER Standard wound dressings
Study Locations (1)
Ohio
- Cleveland Clinic - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 298 participants |
| Start Date | 2015-07 |
| Est. Completion | 2021-02-19 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02509260
The ClinicalTrials.gov registry entry for NCT02509260 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 298 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 557-participant average among 25 other Surgical Site Infection trials with a reported enrollment target (46% lower). The listed sponsor is The Cleveland Clinic, which has 688 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Surgical Site Infection appearing as the primary indexed condition, and to 2 interventions - of which Prevena wound management system is the first listed.
NCT02509260 reports 1 study location spanning 1 distinct geographic area - top geographies include Ohio.
Frequently Asked Questions
What is clinical trial NCT02509260 about?
NCT02509260 is a clinical study titled "Prevena™ Incisional Negative Pressure Wound Therapy in Re-operative Colorectal Surgery". Many strategies have been attempted to reduce SSI rates. The Centers for Medicare and Medicaid Services introduced the Surgical Care Improvement Project infection project with the aim of reducing SSI incidence and morbidity. These measures include prophylactic intravenous antibiotics administered wi...
What is the current status of trial NCT02509260?
This trial is currently completed. It is a NA study. The enrollment target is 298 participants. The study started on 2015-07. Estimated completion is 2021-02-19.
What conditions does trial NCT02509260 study?
This clinical trial studies the following conditions: Surgical Site Infection.
What interventions are being tested in trial NCT02509260?
The interventions under investigation include: Prevena wound management system (DEVICE), Standard wound dressings (OTHER).
Who is sponsoring clinical trial NCT02509260?
This trial is sponsored by The Cleveland Clinic, which has 688 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02509260 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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