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Prevena™ Incisional Negative Pressure Wound Therapy in Re-operative Colorectal Surgery

NCT02509260 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 298

Last updated 2022-11-14

Study results available
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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.

Conditions

  • Surgical Site Infection

Interventions

DEVICE

Prevena wound management system

Patients will have the Prevena wound management system applied post-operatively.

OTHER

Standard wound dressings

Control patients with standard wound dressings will have gauze and tape dressings applied

Sponsors & Collaborators

  • The Cleveland Clinic

    lead OTHER

Principal Investigators

  • David Liska, MD · The Cleveland Clinic

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-31
Primary Completion
2021-02-19
Completion
2021-02-19

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02509260 on ClinicalTrials.gov