Incisional Negative Pressure Wound Therapy
| Status: | Recruiting |
|---|---|
| Conditions: | Orthopedic, Women's Studies |
| Therapuetic Areas: | Orthopedics / Podiatry, Reproductive |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 7/11/2015 |
| Start Date: | December 2012 |
| End Date: | May 2016 |
| Contact: | Jessica R Moreno, RN, BSN |
| Email: | jessica.moreno@duke.edu |
| Phone: | 919-668-6712 |
The Efficacy of Negative Pressure Wound Therapy (NPWT) in the Postoperative Management of Complex Spinal Surgeries: A Randomized Outcomes Study.
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.
therapy in preventing surgical site infections and wound complications (dehiscence) in
high-risk patients undergoing complex spinal surgery.
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.
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.
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
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