Study Stopped
PI leaving institution
Incisional Negative Pressure Wound Therapy
The Efficacy of Negative Pressure Wound Therapy (NPWT) in the Postoperative Management of Complex Spinal Surgeries: A Randomized Outcomes Study.
1 other identifier
interventional
19
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2012
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2012
CompletedFirst Submitted
Initial submission to the registry
December 7, 2012
CompletedFirst Posted
Study publicly available on registry
January 3, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedResults Posted
Study results publicly available
July 2, 2015
CompletedJuly 2, 2015
June 1, 2015
2.5 years
December 7, 2012
June 25, 2015
June 30, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Post-operative Infection (NPWT)
The patient will be assessed for signs/symptoms of infection within the 3 month post-operative period.
3 months
Study Arms (2)
No Negative Pressure Wound Therapy Device
NO INTERVENTIONThis control group will not receive the negative pressure wound therapy device. Post operative dressings will be per the surgeon's standard routine.
NPWT Arm Therapy
EXPERIMENTALThis group will receive NPWT as opposed to the standard incisional dressing following complex spinal surgery.
Interventions
Eligibility Criteria
You may qualify if:
- \>/= 18 years of age
- \>/= 3 level instrumented thoracic, lumbar, or thoracolumbar spinal fusion
You may not qualify if:
- \< 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Duke Universitylead
Study Sites (1)
Duke University Medical Center
Durham, North Carolina, 27710, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Carlos A. Bagley
- Organization
- Duke
Study Officials
- PRINCIPAL INVESTIGATOR
Carlos A Bagley, M.D.
Duke University
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 7, 2012
First Posted
January 3, 2013
Study Start
December 1, 2012
Primary Completion
June 1, 2015
Study Completion
June 1, 2015
Last Updated
July 2, 2015
Results First Posted
July 2, 2015
Record last verified: 2015-06