Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03820219 |
| Other study ID # |
REB1023961 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 15, 2019 |
| Est. completion date |
December 12, 2020 |
Study information
| Verified date |
February 2019 |
| Source |
Nova Scotia Health Authority |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
Patients with surgical site infection (SSI) of the spine have higher morbidity and mortality
and higher costs of care. Hospital length of stay has been shown to be significantly longer,
and readmission rate significantly higher, for infected patients than that for uninfected
patients. Repeated surgery, typically irrigation and debridement (I&D), due to deep SSI is
required in the majority of these patients. The risk of post-operative spinal wound infection
is reported to be 1-20% depending on patient factors, surgical factors and spine pathology
factors. The risk of SSI can be as high as 10-25% in major risk groups, such as posterior
surgical approach in revision lumbar surgery, thoracolumbar trauma with neurological deficit,
and in surgery for metastatic disease. Wound complications such as seroma or dehiscence can
be as high as 40% in spine oncology patients, especially if they have received radiation
and/or chemotherapy. Definitive management is based on etiology, clinical course, and patient
risk factors. A patient who develops a post-operative wound infection often requires
prolonged hospitalization, revision surgical procedures, and long-term intravenous
antibiotics, which significantly increase health care resource utilization, and thus the
overall cost. Awareness of risk factors and development of preventive measures can lead to
improved outcomes.
There are many supplemental treatment strategies for post-operative spine infection and wound
complications in addition to I&D. Vacuum assisted closure (VAC) of infected spine wounds has
proven to be an acceptable adjunct to aid in the closure or staging of complex spinal wounds.
The VAC system has proven to be safe and effective in the treatment of complex spinal wounds,
spinal SSI and wounds that are at high risk for failed primary closure. Indications for VAC
treatment as a means of preventing wound complications are evolving. Preemptive use of VAC
treatment on closed primary wounds has been employed in high risk (morbidly obese) patients
with acetabular fractures, and successful outcomes have been achieved. Use of VAC treatment
on closed wounds as a preventive measure in properly selected patients appears safe and has
effectively decreased wound complication rates. This mode of prophylactic treatment is called
"incisional VAC therapy".
KCI (the manufacturer of a Vacuum Assisted Closure System) has gained FDA and Health Canada
approval for a specific device called "Prevena™", which is designed for incisional vacuum
therapy. 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 and protecting the surgical site from external contamination
in a clean, protected postoperative wound environment.
To date, no studies have been done to establish the efficacy of the Prevena™ System for use
on patients requiring spine surgery to reduce wound complications such as SSI, wound
dehiscence, or seroma formation. A recent systematic review of published studies examining
the use of dressings and drains in posterior spinal surgery found no evidence to support the
use of any particular system. A number of recent studies have also examined the incidence of
surgical site infection in different high-risk populations (10-25%) and a predictive model
for the development of a complex post surgical wound infection. The factors identified lead
to considerable disability, cost and additional utilization of health care resources. If a
prophylactic wound treatment can decrease wound complications in high risk patients, this may
lead to a decreased need for post-operative services, reduced complication rate, less
antibiotic usage and fewer returns to the operating room. If patients can avoid
complications, they can resume normal activities faster and ultimately should have higher
satisfaction.
In an era where health expenditure is literally exploding and becoming non-sustainable in
many countries, cost effectiveness analysis is required to responsibly manage scarce health
care resources. Specifically in the context of SSI, is the added cost of the Prevena™ System
justified by the potential decrease in wound complication rate?
HYPOTHESIS:
Use of the Prevena™ System will decrease the rate of acute post-operative Surgical Site
Infection.
STUDY DESIGN:
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. Consenting and
randomization will be performed by a member of the research team. Post-stratification
randomization will be performed based on the three clinical presentation groups (revision
surgery, metastatic tumor and trauma with deficit). This ensures that the investigators get
appropriate randomization within each of the three clinical groups.
DATA COLLECTION:
The following data elements (with their time of collection) will be collected from the
patient's hospital chart of during follow-up clinical assessment
Patient Factors:
Gender (Consent) Age (Consent) Diabetes (Admission) BMI (Admission) Previous radiation to
planned surgical site (Admission) Currently undergoing chemotherapy (Admission) Smoker
(Admission)
Surgical Factors:
Date of Surgery (Surgery) Surgical Skin Preparation (Surgery) Estimated blood loss (Surgery)
Incision size (Surgery) Drains (Surgery) Instrumentation (Surgery) Number of levels in
decompression/fusion (Surgery) Blood transfusion (Surgery) Type of incision closure -
staples/suture (Surgery) Procedure details - Spine Surgical Invasiveness Index (Surgery)
Hospital Stay:
Admission Date (Admission) Discharge Date (Discharge) ICU admission pre-op (Admission) ICU
admission post-op (Admission) Antibiotic Use (Discharge)
Wound:
Exudate (Follow-up) Erythema (Follow-up) Separation of deep tissues (Follow-up)
Dressing Factors:
Dressing Supply Utilization (Discharge)
Data for each patient will be collected using the patient's hospital chart and visual
inspection of the wound by a clinician. One questionnaire, the EQ5D, will be completed by
study participants, with the help of a research assistant at Baseline (after obtaining
consent), on Post-operative Day 7, Day 14 and Week 6. Participants will also be asked to
complete this questionnaire if they have any unscheduled/unplanned encounters related to the
occurrence of either a primary (SSI) or secondary (dehiscence/seroma) outcome during the
study period.
METHODOLOGY:
Elective patients (revision and some metastatic cases) will be introduced to the study at the
time of surgical consent by a member of the research team. Emergent patients (all trauma and
most metastatic cases) will be introduced to the study pre-operatively in the Emergency
Department or in the Orthopaedic Clinic by a member of the research team. Study participants
will be randomized prior to surgery to receive either the Prevena™ System or standard wound
care.
All consenting participants will be randomized, based on the three primary diagnostic groups
(revision surgery, metastatic disease or fracture with deficit). Study participants who
receive the 'standard wound care' will have the dressing changed 3 days after their surgery
and will have study encounters on Post-operative Day 7, Day 14 and Week 6 for wound
inspection, dressing change (Day 7) and suture/staple removal (Day 14). Study participants
who receive the Prevena™ System will have the same schedule of study encounters for wound
inspection (Post-operative Day 7, Day 14 and Week 6). The Prevena™ System will be removed on
Day 7 and a dry, sterile dressing will be applied. On Day 14 sutures/staples will be removed.
Patients who have not yet been discharged at the time of the scheduled study encounter will
be seen in hospital. Patients who have been discharged prior to any scheduled study
encounters will be seen in a follow-up spine clinic.
Participants will all be assigned a unique study ID and 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.
STATISTICS:
A power calculation has been performed to determine the number of participants required. This
analysis has presumed an incidence of SSI of 15% (based on an averaging calculation of
published data for these high risk groups), and used a 2-tailed analysis, assuming a power of
0.8 and a Type I error of 5%. For a 50% decrease in primary outcome rates, Surgical Site
Infection, (15% to 7.5%), 275 participants per group will be required. The pilot data
generated from the proposed study will allow for refinement of this target recruitment.
