Incisional Negative Pressure Wound Therapy

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 31, 2014