N/A
N=1,869
Negative Pressure Wound Therapy for Prevention of Poststernotomy Infection
Surgical Wound Infection
Bottom Line
View on ClinicalTrials.gov: NCT02020018 ↗Enrolled (actual)
1,869
Serious AEs
0.0%
Results posted
Nov 2019
Primary outcome: Primary: Wound Infection After Open Heart Surgery — 4; 17 Participants — p=0.55
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Prevena Incision Management System (Device); Conventional sterile dry wound dressing (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mayo Clinic
- Primary completion
- Oct 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Wound Infection After Open Heart Surgery |
4; 17 | 0.55 |
| SECONDARY Reoperation for Wound Infection |
— | — |
Summary
This prospective study evaluates the role of negative pressure wound therapy or wound VAC as a dressing over the incision to prevent poststernotomy wound infection in high risk patients.
Eligibility Criteria
Inclusion criteria
- Transplant patients
- BMI >30
- Type I (insulin-dependent) diabetics
- Severe chronic obstructive pulmonary disease (COPD)
- Steroid-dependent patients
- Previous Tracheostomy
Exclusion criteria
- BMI<30
- Thoracotomy
Data sourced from ClinicalTrials.gov (NCT02020018). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.