Incisional Negative Pressure Wound Therapy

June 30, 2015 updated by: Duke University

The Efficacy of Negative Pressure Wound Therapy (NPWT) in the Postoperative Management of Complex Spinal Surgeries: A Randomized Outcomes Study.

The purpose of this study is to evaluate the outcome of incisional negative pressure wound therapy in preventing surgical site infections and wound complications (dehiscence) in high-risk patients undergoing complex spinal surgery.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

This randomized, controlled study will compare the outcomes of NPWT versus the outcomes of not using NPWT in post-operative wound management following a complex spinal surgery. The allocation of patients (no NPWT device versus applying an NPWT device) will be determined by computer-generated randomization. The following data will be collected to determine impact on the outcome of wound management (i.e., infection and wound dehiscence): age, gender, body mass index (BMI), dorsal fat, estimated blood loss during the surgical procedure, length of surgery, length of hospital stay, highest peri-operative glucose, medical comorbidities, and history of infection.

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • >/= 18 years of age
  • >/= 3 level instrumented thoracic, lumbar, or thoracolumbar spinal fusion

Exclusion Criteria:

  • < 18 years of age
  • < 3 level instrumented thoracic, lumbar, or thoracolumbar spinal fusion
  • Spinal infection at time of surgery
  • History of immunosuppression or chronic systemic infection
  • Pregnancy
  • Inability to provide informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: No Negative Pressure Wound Therapy Device
This control group will not receive the negative pressure wound therapy device. Post operative dressings will be per the surgeon's standard routine.
EXPERIMENTAL: NPWT Arm Therapy
This group will receive NPWT as opposed to the standard incisional dressing following complex spinal surgery.
Device: Negative pressure wound therapy (NPWT)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Post-operative Infection (NPWT)
Time Frame: 3 months
The patient will be assessed for signs/symptoms of infection within the 3 month post-operative period.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Investigators

  • Principal Investigator: Carlos A Bagley, M.D., Duke University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (ACTUAL)

June 1, 2015

Study Completion (ACTUAL)

June 1, 2015

Study Registration Dates

First Submitted

December 7, 2012

First Submitted That Met QC Criteria

January 2, 2013

First Posted (ESTIMATE)

January 3, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

July 2, 2015

Last Update Submitted That Met QC Criteria

June 30, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00040054

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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