WoundVac in Obese Patients Undergoing Lumbar Surgery

NCT03688438 | Unknown FDA Device

• 1 other identifier: 18.1023
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

Brief 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

Obesity; Lumbar Spine Surgery

Outcome Measures

Primary Outcomes (1)

• Incidence of wound complication

  A wound complication can include a local inflammatory reaction, wound dehiscence, skin blistering/necrosis, stitch abscess or Incision and drainage for hematoma seroma, deep or superficial infection

  Within one month after surgery

Secondary Outcomes (1)

• Days to dry wound

  One month after surgery

Study Arms (2)

Standard of Care

NO INTERVENTION

Standard of care wound closure and dressing No active interventions

WoundVAC (CINPT)

EXPERIMENTAL

Closed-Incision Negative-Pressure Therapy

Device: Closed-Incision Negative-Pressure Therapy

Interventions

Closed-Incision Negative-Pressure Therapy DEVICE

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.

Also known as: WoundVac

WoundVAC (CINPT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients aged ≥18 years old
• Patients undergoing posterior lumbar fusion with or without interbody fusion
• Body Mass Index of ≥35kg/m2
• Able to provide Informed Consent
• No prior lumbar spine surgery

You may not qualify if:

• Presence of skin infection or any systemic infection
• Known allergy or sensitivity to silver or acrylic adhesive
• Fragile peri-incisional skin
• Patients on anti-coagulation and/or platelet aggregation inhibitors

Sponsors & Collaborators

• Norton Leatherman Spine Center: lead

Study Sites (1)

Norton Leatherman Spine Center

Louisville, Kentucky, 40202, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Charles II H Crawford, MD

  Norton Leatherman S[ine Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Leah Y Carreon, MD, MSc

CONTACT

5029920488; spineresearch@nortonhealthcare.org

Kelly R Bratcher, RN

CONTACT

5029920488; kelly.bratcher2@nortonhealthcare.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two study arms: (1) Standard of Care and (2) WoundVac

Study Record Dates

• First Submitted: September 26, 2018
• First Posted: September 28, 2018
• Study Start: October 15, 2018
• Primary Completion: October 15, 2019
• Study Completion: October 15, 2020
• Last Updated: September 28, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)