Incisional Negative Pressure Wound Therapy

This study is currently recruiting participants.
Verified February 2014 by Duke University
Sponsor:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01759381
First received: December 7, 2012
Last updated: February 14, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Spinal Deformity
Device: Negative pressure wound therapy (NPWT)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: The Efficacy of Negative Pressure Wound Therapy (NPWT) in the Postoperative Management of Complex Spinal Surgeries: A Randomized Outcomes Study.

Further study details as provided by Duke University:

Primary Outcome Measures:
  • Post-operative infection (NPWT) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    The patient will be assessed for signs/symptoms of infection within the 3 month post-operative period.


Estimated Enrollment: 100
Study Start Date: December 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01759381

Contacts
Contact: Jessica R Moreno, RN, BSN 919-668-6712 jessica.moreno@duke.edu

Locations
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Jessica R. Moreno, RN, BSN    919-668-6712    jessica.moreno@duke.edu   
Principal Investigator: Carlos A Bagley, M.D.         
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: Carlos A Bagley, M.D. Duke University
  More Information

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01759381     History of Changes
Other Study ID Numbers: Pro00040054
Study First Received: December 7, 2012
Last Updated: February 14, 2014
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Duke University:
Spinal Deformity
Complex Spinal Surgery
Negative Pressure Wound Therapy
Post-Operative Infection

Additional relevant MeSH terms:
Congenital Abnormalities

ClinicalTrials.gov processed this record on April 15, 2014