Incisional Negative Pressure Wound Therapy
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Purpose
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 | Intervention |
|---|---|
|
Spinal Deformity |
Procedure: Negative pressure wound therapy (NPWT) |
| Study Type: | Interventional |
| 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. |
- 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.
| Estimated Enrollment: | 100 |
| Study Start Date: | December 2012 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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 recieve NPWT as opposed to the standard incisional dressing following complex spinal surgery.
|
Procedure: 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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
Contacts and Locations| Contact: Jessica R Moreno, RN, BSN | 919-668-6712 | jessica.moreno@duke.edu |
| United States, North Carolina | |
| Duke University Medical Center | Recruiting |
| Durham, North Carolina, United States, 27710 | |
| Contact: Jessica R. Moreno, RN, BSN 919-668-6712 jessica.moreno@duke.edu | |
| Principal Investigator: Carlos A Bagley, M.D. | |
| Principal Investigator: | Carlos A Bagley, M.D. | Duke University |
More Information
No publications provided
| Responsible Party: | Duke University |
| ClinicalTrials.gov Identifier: | NCT01759381 History of Changes |
| Other Study ID Numbers: | Pro00040054 |
| Study First Received: | December 7, 2012 |
| Last Updated: | January 2, 2013 |
| Health Authority: | United States: Institutional Review Board United States: Food and Drug Administration |
Keywords provided by Duke University:
|
Spinal Deformity Complex Spinal Surgery Negative Pressure Wound Therapy Post-Operative Infection |
Additional relevant MeSH terms:
|
Congenital Abnormalities |
ClinicalTrials.gov processed this record on May 19, 2013