At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 10 enrolled
Drug / intervention
Negative Pressure treatmentdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Prospective Observational Study of the Use of Negative Pressure Wound in High Risk Surgical Closed Incisions.
In Brief
A Phase 4 clinical trial evaluating Negative Pressure treatment for High Risk Abdominal Wounds. Completed, enrolled 10 participants across 1 site.
Detailed Summary
The purpose of this study is to investigate the use of Negative Pressure Wound Therapy in high risk surgical wounds to evaluate the rate of surgical site infections (SSIs). Hypothesis: Historically, the average rates of infective complications in surgical wounds types are 7.7% in clean wounds, 15% for contaminated and 35-40% for dirty wounds. The application of Prevena ™ Incision Management System (Kinetic Concepts Inc, San Antonio, TX) is expected to reduce these rates by 50%.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHigh Risk Abdominal Wounds
CountriesUnited States
Collaborators--
Timeline
Phase 4CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartMay 2014
First PostedMay 2014
Primary CompletionSep 2016
TodayJul 2026
First PostedMay 13, 2014
Enrollment StartMay 1, 2014
Primary CompletionSep 1, 2016
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 12.1 years ago
Interventions
Negative Pressure treatmentdevice