Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Incisional Negative Pressure Wound Therapy in Patients Undergoing Spine 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03820219
Recruitment Status : Not yet recruiting
First Posted : January 29, 2019
Last Update Posted : February 19, 2019
Sponsor:
Information provided by (Responsible Party):
Andrew Glennie, Nova Scotia Health Authority

Brief Summary:

Introduction: Posterior post-operative spine wounds involving surgery at multiple levels are known to have higher rates of wound complications relative to other areas of the body. Instrumentation, repeat surgery and prior radiation all contribute to more hostile environments for wound healing. The purpose of this study is to determine whether incisional vacuum dressings can help improve the healing/complication rates associated with these wounds.

Methods: Patients will be recruited over a two year span as part of the initial pilot study to determine the capabilities/practicality of recruitment locally. Patients will be followed in and out of hospital for 3 months or until the wound has healed clinically. The primary outcome, surgical site infection (SSI), will be evaluated using prior Centre for Disease Control (CDC) definitions. STATA will be used for statistical analysis.

Anticipated results: Although the incisional vacuum system (PrevenaTM) has been used previously for spine wounds, there are no randomized control trials compared with standard dressings. Since the infection rate in these wounds has been founds previously to be quite high (10-25%) a reduction could have profound significant benefits on patient morbidity and overall costs to the healthcare system. The pilot study will help inform the direction of a larger, potentially multi-centered trial.

Conclusion: If a large treatment effect is demonstrated with the PrevenaTM System then this could potentially change the standard of care for complex spine wounds.


Condition or disease Intervention/treatment Phase
Surgical Site Infection Device: Prevena™ system Other: Standard sterile wound dressing Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Consenting patients will be randomized to receive either standard sterile wound dressing or the Prevena™ System at the time of closure of the surgical wound.
Masking: None (Open Label)
Masking Description: The treatment allocation will be hidden for the purposes of analysis. It will be impossible to blind physicians or participants to the treatment group given the obvious difference in appearance of the Prevena™ System versus standard wound dressing.
Primary Purpose: Treatment
Official Title: A Pilot Study Comparing Incisional Negative Pressure Wound Therapy (Prevena) to Conventional Sterile Dressing in Patients Undergoing Thoracolumbar Posterior Spine Surgery
Estimated Study Start Date : March 15, 2019
Estimated Primary Completion Date : March 15, 2021
Estimated Study Completion Date : March 15, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Standard sterile wound dressing
Standard wound care involves the application of an occlusive dressing in the operating room, a dressing change on Post-operative Day 3 and then dressing changes as needed until suture/staple removal on Post-operative Day 14.
Other: Standard sterile wound dressing
Standard wound care involves the application of an occlusive dressing in the operating room.

Active Comparator: Prevena™ system
The Prevena™ System is indicated for use over clean, closed incisions that continue to drain following sutured or stapled closure. It acts by removing exudate, helping hold the edges of the incision together, protecting the surgical site from external contamination in a clean, protected postoperative wound environment, until it is removed at Post-Operative Day 7.
Device: Prevena™ system
The Prevena™ System acts by removing exudate from a clean, closed incision. It helps hold the edges of the incision together, protecting the surgical site from external contamination in a clean, protected postoperative wound environment.




Primary Outcome Measures :
  1. Rate of acute post-operative Surgical Site Infection (SSI) [ Time Frame: 6 weeks ]
    The incidence rate of SSI for patients with the Prevena™ System will be compared to those with the standard dressing.


Secondary Outcome Measures :
  1. Post operative wound seroma or dehiscence [ Time Frame: 1 week ]
    The incidence of wounds requiring aspiration, surgical exploration, or incision repair for patients with the Prevena™ System will be compared to those with the standard dressing.

  2. Resource time commitment [ Time Frame: 2 weeks ]
    The time and resource commitment for post-operative, in-hospital, wound management for patients with the Prevena™ System will be compared to those with the standard dressing. This data is collected on a standardized log sheet appended to the nursing folio.

  3. Return visits [ Time Frame: 6 weeks ]
    The number of unanticipated post-op clinic visits, hospital readmissions and, emergency department/urgent-unplanned clinic evaluations for patients with the Prevena™ System will be compared to those with the standard dressing.



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.


Layout table for eligibility information
Ages Eligible for Study:   17 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Capable of and agree to consent to randomization
  • Require spine surgery with a posterior midline incision that involves the thoracic, lumbar and/or sacral spine
  • Be one of the following clinical presentation groups:

    1. Metastatic Tumor of the Thoracic or Lumbar spine (T1-S5), requiring instrumentation and decompression, with or without pre-operative site radiation
    2. Revisions Surgery requiring additional instrumentation or revision instrumentation, for thoracolumbar degeneration or deformity (T1-S1), index surgery >6 months prior
    3. Acute Traumatic Thoracolumbar (T1-L5) fracture(s) with neurological deficit (AIS A-C), requiring instrumentation and decompression

Exclusion Criteria:

Initially:

  • Undergoing percutaneous surgery
  • Active Surgical Site infection or Primary Spinal Column infection or Distant Site Infection (urinary tract, respiratory tract, etc.)

Subsequently:

  • Failure to complete the 6-week clinical follow-up (Loss to Follow Up)
  • Second surgery, at the same anatomical site, required during study time period (six weeks), for causes other than primary (SSI) or secondary (Dehiscence, Seroma) study endpoints.
Layout table for additonal information
Responsible Party: Andrew Glennie, Principal Investigator, Orthopaedic Spine Surgeon, Nova Scotia Health Authority
ClinicalTrials.gov Identifier: NCT03820219    
Other Study ID Numbers: REB1023961
First Posted: January 29, 2019    Key Record Dates
Last Update Posted: February 19, 2019
Last Verified: February 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Andrew Glennie, Nova Scotia Health Authority:
spine
surgical dressing
negative pressure therapy
surgical infection
Additional relevant MeSH terms:
Layout table for MeSH terms
Surgical Wound Infection
Infection
Wound Infection
Postoperative Complications
Pathologic Processes