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WoundVac in Obese Patients Undergoing Lumbar Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03688438
Recruitment Status : Unknown
Verified September 2018 by Norton Leatherman Spine Center.
Recruitment status was:  Not yet recruiting
First Posted : September 28, 2018
Last Update Posted : September 28, 2018
Sponsor:
Information provided by (Responsible Party):
Norton Leatherman Spine Center

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.

Condition or disease Intervention/treatment Phase
Obesity Lumbar Spine Surgery Device: Closed-Incision Negative-Pressure Therapy Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 124 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Two study arms: (1) Standard of Care and (2) WoundVac
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: 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
Estimated Study Start Date : October 15, 2018
Estimated Primary Completion Date : October 15, 2019
Estimated Study Completion Date : October 15, 2020

Resource links provided by the National Library of Medicine


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 Name: WoundVac




Primary Outcome Measures :
  1. Incidence of wound complication [ Time Frame: Within one month after surgery ]
    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


Secondary Outcome Measures :
  1. Days to dry wound [ Time Frame: One month after surgery ]
    Number of days after surgery it took to have the wound become dry



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03688438


Contacts
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Contact: Leah Y Carreon, MD, MSc 5029920488 ext 14139 spineresearch@nortonhealthcare.org
Contact: Kelly R Bratcher, RN 5029920488 ext 14131 kelly.bratcher2@nortonhealthcare.org

Locations
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United States, Kentucky
Norton Leatherman Spine Center
Louisville, Kentucky, United States, 40202
Contact: Leah Y Carreon, MD, MSc    502-992-0488 ext 14139    spineresearch@nortonhealthcare.org   
Contact: Kelly R Bratcher, RN    5029920488 ext 14161    kelly.bratcher2@nortonhealthcare.org   
Principal Investigator: Charles II H Crawford, MD         
Sub-Investigator: Steven D Glassman, 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         
Sponsors and Collaborators
Norton Leatherman Spine Center
Investigators
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Principal Investigator: Charles II H Crawford, MD Norton Leatherman S[ine Center
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Responsible Party: Norton Leatherman Spine Center
ClinicalTrials.gov Identifier: NCT03688438    
Other Study ID Numbers: 18.1023
First Posted: September 28, 2018    Key Record Dates
Last Update Posted: September 28, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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