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WoundVac in Obese Patients Undergoing Lumbar Surgery

NCT03688438 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 124

Last updated 2018-09-28

No results posted yet for this study

Summary

This is an open label, randomized clinical trial of Closed-Incision Negative-Pressure Therapy to decrease post-operative wound complications in patients with BMI ≥35kg/m2 after posterior lumbar spine surgery.

Conditions

Interventions

DEVICE

Closed-Incision Negative-Pressure Therapy

A foam or gauze dressing is put directly on the wound. This foam acts as a filter to keep any large particles (such as blood clots or dead, sloughed off tissue) from clogging the vacuum system. A clear, occlusive, adhesive film covers and seals the dressing and wound, creating an airtight seal. A drainage tube leads from under the adhesive film and connects to a portable vacuum pump. This pump removes air pressure over the wound. The pump is programmed for strength of suction, amount of time it is to be applied and if it is to be intermittent or continuous. A chamber on the pump collects drainage and moisture is drawn away from the wound site.

Sponsors & Collaborators

  • Norton Leatherman Spine Center

    lead OTHER

Principal Investigators

  • Charles II H Crawford, MD · Norton Leatherman S[ine Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-15
Primary Completion
2019-10-15
Completion
2020-10-15
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03688438 on ClinicalTrials.gov