Incisional Negative Pressure Wound Therapy

Not Applicable

Terminated

• Conditions: Spinal Deformity
• Interventions: Device: Negative pressure wound therapy (NPWT)

• Registration Number: NCT01759381
• Lead Sponsor: Duke University

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.

Study Timeline

• Study Start: 2012-12
• Study First Submitted: 2012-12-07
• Study First Submitted QC: 2013-01-02
• Study First Posted: 2013-01-03
• Status Verified: 2015-06
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Results First Submitted: 2015-06-25
• Results First Submitted QC: 2015-06-30
• Last Update Submitted: 2015-06-30
• Results First Posted: 2015-07-02
• Last Update Posted: 2015-07-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 19

Inclusion Criteria

• >/= 18 years of age
• >/= 3 level instrumented thoracic, lumbar, or thoracolumbar spinal fusion

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NPWT Arm Therapy	Negative pressure wound therapy (NPWT)	This group will receive NPWT as opposed to the standard incisional dressing following complex spinal surgery.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Post-operative Infection (NPWT)	3 months	The patient will be assessed for signs/symptoms of infection within the 3 month post-operative period.

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States