Incisional Negative Pressure Wound Therapy
Primary Purpose
Spinal Deformity
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Negative pressure wound therapy (NPWT)
Sponsored by
About this trial
This is an interventional prevention trial for Spinal Deformity focused on measuring Spinal Deformity, Complex Spinal Surgery, Negative Pressure Wound Therapy, Post-Operative Infection
Eligibility 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
Sites / Locations
- Duke University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
No Negative Pressure Wound Therapy Device
NPWT Arm Therapy
Arm Description
This control group will not receive the negative pressure wound therapy device. Post operative dressings will be per the surgeon's standard routine.
This group will receive NPWT as opposed to the standard incisional dressing following complex spinal surgery.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01759381
Brief Title
Incisional Negative Pressure Wound Therapy
Official Title
The Efficacy of Negative Pressure Wound Therapy (NPWT) in the Postoperative Management of Complex Spinal Surgeries: A Randomized Outcomes Study.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Terminated
Why Stopped
PI leaving institution
Study Start Date
December 2012 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Deformity
Keywords
Spinal Deformity, Complex Spinal Surgery, Negative Pressure Wound Therapy, Post-Operative Infection
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
No Negative Pressure Wound Therapy Device
Arm Type
No Intervention
Arm Description
This control group will not receive the negative pressure wound therapy device. Post operative dressings will be per the surgeon's standard routine.
Arm Title
NPWT Arm Therapy
Arm Type
Experimental
Arm Description
This group will receive NPWT as opposed to the standard incisional dressing following complex spinal surgery.
Intervention Type
Device
Intervention Name(s)
Negative pressure wound therapy (NPWT)
Primary Outcome Measure Information:
Title
Number of Participants With Post-operative Infection (NPWT)
Description
The patient will be assessed for signs/symptoms of infection within the 3 month post-operative period.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carlos A Bagley, M.D.
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
12. IPD Sharing Statement
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Incisional Negative Pressure Wound Therapy
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