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Incisional Negative Pressure Wound Therapy in Patients Undergoing Spine Surgery

NCT03820219 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2023-02-02

No results posted yet for this study

Summary

Introduction: Posterior post-operative spine wounds involving surgery at multiple levels are known to have higher rates of wound complications relative to other areas of the body. Instrumentation, repeat surgery and prior radiation all contribute to more hostile environments for wound healing. The purpose of this study is to determine whether incisional vacuum dressings can help improve the healing/complication rates associated with these wounds.

Methods: Patients will be recruited over a two year span as part of the initial pilot study to determine the capabilities/practicality of recruitment locally. Patients will be followed in and out of hospital for 3 months or until the wound has healed clinically. The primary outcome, surgical site infection (SSI), will be evaluated using prior Centre for Disease Control (CDC) definitions. STATA will be used for statistical analysis.

Anticipated results: Although the incisional vacuum system (PrevenaTM) has been used previously for spine wounds, there are no randomized control trials compared with standard dressings. Since the infection rate in these wounds has been founds previously to be quite high (10-25%) a reduction could have profound significant benefits on patient morbidity and overall costs to the healthcare system. The pilot study will help inform the direction of a larger, potentially multi-centered trial.

Conclusion: If a large treatment effect is demonstrated with the PrevenaTM System then this could potentially change the standard of care for complex spine wounds.

Conditions

  • Surgical Site Infection

Interventions

DEVICE

Prevena™ system

The Prevena™ System acts by removing exudate from a clean, closed incision. It helps hold the edges of the incision together, protecting the surgical site from external contamination in a clean, protected postoperative wound environment.

OTHER

Standard sterile wound dressing

Standard wound care involves the application of an occlusive dressing in the operating room.

Sponsors & Collaborators

  • Nova Scotia Health Authority

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-15
Primary Completion
2020-03-15
Completion
2020-12-12

Countries

  • Canada

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 NCT03820219 on ClinicalTrials.gov