18 and older, any sex, with Surgical Site Occurences After Sternotomy or Wound Infection. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Surgical Site Infection (SSI) Rate Within 34 Days Postoperatively, Defined as Superficial, Deep, and Organ/Space Infections as Per CDC Guidelines.Primary· 30 ± 4 days
The SSI rate (in %) was calculated for each treatment arm as follows:
SSI rate = \[Number of Subjects who experienced SSI\] / \[Number of Subjects Analyzed\] \* 100 Subjects included in the numerator for the SSI rate computation must have experienced an SSI post-surgery up to Day 30 (± 4 days). If a subject has the same SSI event on multiple occasions or experiences several events of other SSIs, the subject will be counted only once in the numerator for the first event
Group
Value
95% CI
Prevena™ Incision Management System
9.0
Conventional Sterile Wound Dressings
10.4
Adverse events — posted to ClinicalTrials.gov
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The purpose of this study is to compare the use of Prevena™ Incision Management System (IMS) versus standard wound care for the incision in subjects undergoing a sternal midline incision (sternotomy). The subjects targetted for the study are at high risk for surgical complications (like infections) around the environment of the incision.
The study is conducted in The Netherlands, Germany and Austria.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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Sponsor: as reported to ClinicalTrials.gov by Solventum US LLC
Last refreshed: 2 October 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02195310.