Incisional Negative Pressure Wound Therapy
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.
|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.|
- Number of Participants With 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.
|Study Start Date:||December 2012|
|Study Completion Date:||June 2015|
|Primary Completion Date:||June 2015 (Final data collection date for primary outcome measure)|
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)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01759381
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27710|
|Principal Investigator:||Carlos A Bagley, M.D.||Duke University|