N/A
N=298
Prevena™ Incisional Negative Pressure Wound Therapy in Re-operative Colorectal Surgery
Surgical Site Infection
Bottom Line
View on ClinicalTrials.gov: NCT02509260 ↗Enrolled (actual)
298
Serious AEs
10.1%
Results posted
Nov 2022
Primary outcome: Primary: Occurrence of Superficial Surgical Site Infection — 11; 21; 107; 128 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Prevena wound management system (Device); Standard wound dressings (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The Cleveland Clinic
- Primary completion
- Feb 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Occurrence of Superficial Surgical Site Infection |
11; 21; 107; 128 | — |
| SECONDARY Length of Hospital Stay, |
7; 6 | — |
| SECONDARY Cost Effectiveness |
— | — |
| SECONDARY Clinical Efficacy of the Device in Relation to the Degree of Contamination |
15; 12; 94; 90; 39; 45 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 18 years of age
- re-operative colorectal surgery
- excision or revision of prior anastomosis
- intestinal resection
- incisional hernia repair
- enterocutaneous fistula repair
- emergency settings
Exclusion Criteria
- Laparoscopic or laparoscopic assisted procedures
- patients who had undergone a laparotomy within the preceding three months
- an active SSI at the time of surgery
Data sourced from ClinicalTrials.gov (NCT02509260). 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.