Incisional Negative Pressure Wound Therapy in Patients Undergoing Spine Surgery
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|ClinicalTrials.gov Identifier: NCT03820219|
Recruitment Status : Not yet recruiting
First Posted : January 29, 2019
Last Update Posted : February 19, 2019
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|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.|
|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|
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.
- 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.
- 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.
- 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.
- 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.