NCT01759381

Incisional Negative Pressure Wound Therapy

The Efficacy of Negative Pressure Wound Therapy (NPWT) in the Postoperative Management of Complex Spinal Surgeries: A Randomized Outcomes Study.

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Spinal Deformity

Interventions

Type	Name	Description
DEVICE	Negative pressure wound therapy (NPWT)

Timeline

• Start date: 2012-12-01
• Primary completion: 2015-06-01
• Completion: 2015-06-01
• First posted: 2013-01-03
• Last updated: 2015-07-02
• Results posted: 2015-07-02

Locations

1 site across 1 country: United States