Incisional Negative Pressure Wound Therapy

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Duke University

Status

Terminated

Conditions

Spinal Deformity

Treatments

Device: Negative pressure wound therapy (NPWT)

Study type

Interventional

Funder types

Other

Identifiers

NCT01759381
Pro00040054

Details and patient eligibility

About

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.

Full 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.

Enrollment

19 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

19 participants in 2 patient groups

No Negative Pressure Wound Therapy Device
No Intervention group
Description:
This control group will not receive the negative pressure wound therapy device. Post operative dressings will be per the surgeon's standard routine.
NPWT Arm Therapy
Experimental group
Description:
This group will receive NPWT as opposed to the standard incisional dressing following complex spinal surgery.
Treatment:
Device: Negative pressure wound therapy (NPWT)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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