Incisional Negative Pressure Wound Therapy

Spinal Deformity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01759381
• Other study ID #: Pro00040054
• Status: Terminated
• Phase: N/A
• First received: December 7, 2012
• Last updated: June 30, 2015
• Start date: December 2012
• Est. completion date: June 2015

Study information

• Verified date: June 2015
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 19
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Spinal Deformity

Intervention

Device:
• Negative pressure wound therapy (NPWT)

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 months	No