Incisional Negative Pressure Wound Therapy
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|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
|Condition or disease||Intervention/treatment||Phase|
|Spinal Deformity||Device: Negative pressure wound therapy (NPWT)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||19 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Primary Completion Date :||June 2015|
|Actual Study Completion Date :||June 2015|
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)
- 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.
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|
|Principal Investigator:||Carlos A Bagley, M.D.||Duke University|