N/A
N=40
Prophylactic Application of an Incisional Wound Vac to Prevent Wound Complications in Obese Spine Surgery Patients
Spine Surgery · Wounds Vac
Bottom Line
View on ClinicalTrials.gov: NCT02926924 ↗Enrolled (actual)
40
Serious AEs
14.6%
Results posted
Apr 2025
Primary outcome: Primary: Count of Patients With Post Operative Infection — 4; 2; 5; 3 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Wound Vac (Device); Standard Dressing (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Michigan
- Primary completion
- Jan 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Count of Patients With Post Operative Infection |
4; 2; 5; 3 | — |
Summary
This is a prospective randomized study evaluating the use of a prophylactic incision wound vac dressing, applied in the OR, on patients undergoing posterior spine surgery with a BMI>35. Patients are randomized in the operating room to normal postoperative dressing vs. vac dressing. The vac dressing would be left on for 72 hours postoperatively. In the interim, the patients' postoperative care can proceed as usual. Our primary outcomes will be antibiotics or return trip needed to the operating room for wound related complications.
The patients only intervention would be the application of an incisional wound vac. The will be no change in the patients postoperative protocol otherwise. This procedure is noninvasive.
Eligibility Criteria
Inclusion Criteria
- Be scheduled to have posterior spine surgery (inpatient procedures only).
- Have a BMI greater than or equal to 35.
Exclusion Criteria
- BMI less than 35
- Previous spine infection
- Intraoperative dural tear
Data sourced from ClinicalTrials.gov (NCT02926924). 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.