WoundVac in Obese Patients Undergoing Lumbar Surgery

Post Operative Wound Complications in Patients With BMI ≥35kg/m2 After Posterior Lumbar Spine Surgery: a Randomized Clinical Trial of Closed-Incision Negative-Pressure Therapy

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.

Study Overview

• Status: Unknown
• Conditions: Obesity; Lumbar Spine Surgery
• Intervention / Treatment: Device: Closed-Incision Negative-Pressure Therapy

Detailed Description

Methods:

Study Design: Prospective open-label randomized clinical trial of CINPT in obese patients. Subjects will be randomized in a 1:1 to Standard of Care (SOC) and CINPT.

Study Arms: (1) Standard of Care (2) CINPT Sample Size: Based on 30% incidence of wound complications in obese patients undergoing lumbar spine surgery, a sample size of 124 (62 in each cohort) will be needed to detect a decreased incidence of 10% with an α of 0.05 and β of 0.2.

Randomization: Randomization will be done with varying blocks of 4, 6 and 8 using opaque sealed envelopes.

Procedures: All patients will receive standard pre operative prophylactic antibiotics with 2g - 3g Cefazolin or 1g Clindamycin (if patient has known penicillin allergy) based on weight 60 min before incision is made. They will be clipped if needed before being prepped. Each patient will be prepped with alcohol and then either duraprep, chloraprep, or betadine. After the procedure is complete, a subfascial and subcutaneous closed suction drain will be placed in the wound prior to closure. 1 to 3 gram of Vancomycin powder will be placed in the wound. The wound is closed with #1vicryl for the fascial layer followed by 2-0 Vicryl for the subcutaneous layer followed by 3-0 or 4-0 monocryl. In the SOC group, skin glue, Steri-strips, sterile gauze and Tegaderm will be applied to the wound. In the CINPT group, a CINPT dressing will be placed and attached to a compact portable negative pressure unit to deliver 125mmHg continuous pressure for 5 to 7 days. All patients will receive standard wound care instructions before hospital discharge. Patients will return to the clinic in 6±1 days for a wound check and removal of the CINPT.

Primary endpoint: The primary endpoint is the occurrence of a 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

• Study Type: Interventional
• Enrollment (Anticipated): 124
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Leah Y Carreon, MD, MSc; Phone Number: 14139 5029920488; Email: spineresearch@nortonhealthcare.org
• Study Contact Backup: Name: Kelly R Bratcher, RN; Phone Number: 14131 5029920488; Email: kelly.bratcher2@nortonhealthcare.org

Study Locations

• United States
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Norton Leatherman Spine Center
      • Contact: Leah Y Carreon, MD, MSc; Phone Number: 14139 502-992-0488; Email: spineresearch@nortonhealthcare.org
      • Contact: Kelly R Bratcher, RN; Phone Number: 14161 5029920488; Email: kelly.bratcher2@nortonhealthcare.org
      • Principal Investigator: Charles II H Crawford, MD
      • Sub-Investigator: John II R Dimar, MD
      • Sub-Investigator: Mladen Djurasovic, MD
      • Sub-Investigator: Roger K Owens, MD
      • Sub-Investigator: Jeffrey L Gum, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: Standard of Care; Standard of care wound closure and dressing No active interventions
EXPERIMENTAL: WoundVAC (CINPT); Closed-Incision Negative-Pressure Therapy	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.; Other Names: WoundVac

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Days to dry wound	Number of days after surgery it took to have the wound become dry	One month after surgery

Collaborators and Investigators

• Sponsor: Norton Leatherman Spine Center
• Investigators: Principal Investigator: Charles II H Crawford, MD, Norton Leatherman S[ine Center

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): October 15, 2018
• Primary Completion (ANTICIPATED): October 15, 2019
• Study Completion (ANTICIPATED): October 15, 2020

Study Registration Dates

• First Submitted: September 26, 2018
• First Submitted That Met QC Criteria: September 27, 2018
• First Posted (ACTUAL): September 28, 2018

Study Record Updates

• Last Update Posted (ACTUAL): September 28, 2018
• Last Update Submitted That Met QC Criteria: September 27, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 18.1023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No