Incisional Negative Pressure Wound Therapy in Patients Undergoing Spine Surgery

NCT03820219 | Completed DMC

• 1 other identifier: REB1023961
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgical Site Infection

Keywords

spine; surgical dressing; negative pressure therapy; surgical infection

Outcome Measures

Primary Outcomes (1)

• Rate of acute post-operative Surgical Site Infection (SSI)

  The incidence rate of SSI for patients with the Prevena™ System will be compared to those with the standard dressing.

  6 weeks

Secondary Outcomes (3)

• Post operative wound seroma or dehiscence

  1 week

• Resource time commitment

  2 weeks

• Return visits

  6 weeks

Study Arms (2)

Standard sterile wound dressing

PLACEBO COMPARATOR

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

Prevena™ system

ACTIVE COMPARATOR

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

Interventions

Prevena™ system DEVICE

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.

Prevena™ system

Standard sterile wound dressing OTHER

Standard wound care involves the application of an occlusive dressing in the operating room.

Standard sterile wound dressing

Eligibility Criteria

• Age: 17 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nova Scotia Health Authority: lead

Study Sites (1)

Nova Scotia Health

Halifax, Nova Scotia (NS), B3L 4P1, Canada

Location

MeSH Terms

Conditions

Surgical Wound Infection

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

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

Model Details: 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.

Study Record Dates

• First Submitted: January 25, 2019
• First Posted: January 29, 2019
• Study Start: July 15, 2019
• Primary Completion: March 15, 2020
• Study Completion: December 12, 2020
• Last Updated: February 2, 2023

Record last verified: 2019-02

Locations

CA (1)