We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

Incisional Negative Pressure Wound Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01759381
Recruitment Status : Terminated (PI leaving institution)
First Posted : January 3, 2013
Results First Posted : July 2, 2015
Last Update Posted : July 2, 2015
Information provided by (Responsible Party):
Duke University

Brief Summary:
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 or disease Intervention/treatment
Spinal Deformity 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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.
Study Start Date : December 2012
Primary Completion Date : June 2015
Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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)

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01759381

United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Principal Investigator: Carlos A Bagley, M.D. Duke University

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01759381     History of Changes
Other Study ID Numbers: Pro00040054
First Posted: January 3, 2013    Key Record Dates
Results First Posted: July 2, 2015
Last Update Posted: July 2, 2015
Last Verified: June 2015

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

Additional relevant MeSH terms:
Congenital Abnormalities