Clinical Trials Logo

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:

Read more »
Read more »

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Canada Nova Scotia Health Halifax Nova Scotia (NS)

Sponsors (1)

Lead Sponsor Collaborator
Nova Scotia Health Authority

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Post operative wound seroma or dehiscence 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. 1 week
Secondary Resource time commitment 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. 2 weeks
Secondary Return visits 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. 6 weeks
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04096885 - The Inselspital Surgical Cohort Study
Terminated NCT03820648 - Wound Protector Dual-ring Alexis® in Pancreaticoduodenectomy N/A
Completed NCT04067843 - Effect of Photodynamic Treatment on Skin Microbiome. Single Center Study N/A
Terminated NCT04042077 - Delafloxacin IV and OS Administration Compared to Best Available Therapy in Patients With Surgical Site Infections Phase 3
Completed NCT05841576 - Anaesthetic Management Guided by COMET Measurements N/A
Withdrawn NCT05338281 - NPWT for Abdominal Incisions in DIEP Reconstructions: A RCT N/A
Recruiting NCT03042091 - Neomycin and Metronidazole Hydrochloride With or Without Polyethylene Glycol in Reducing Infection in Patients Undergoing Elective Colorectal Surgery Early Phase 1
Completed NCT01697748 - Prospective Study on Cesarean Wound Outcomes N/A
Terminated NCT01789697 - Text Message Study N/A
Recruiting NCT05966961 - Novosyn® CHD vs Polyglactin 910 Suture to Close Wounds After Emergency or Elective Laparotomy or Laparoscopic Surgery
Recruiting NCT05077592 - Addition of Pre-wound Closure Povidone Iodine Wash Versus Direct Wound Closure Effect on Surgical Site Infections Phase 4
Recruiting NCT05763602 - PVI to Prevent S. Aureus SSI After Fixation of HELEF (POTENT Study) Phase 4
Recruiting NCT05502380 - Broad-spectrum Antibiotic Prophylaxis in Tumor and Infected Orthopedic Surgery Phase 3
Recruiting NCT03221023 - Intrawound Vancomycin Prophylaxis for Neural Stimulator Phase 2/Phase 3
Completed NCT03257202 - Topical Treatment and Prevalence of P. Acnes Phase 2
Completed NCT06154720 - Surgical Site Infection After Episiotomy Repair Related to Routine Use of Antibiotic Prophylaxis in Low-Risk Population
Not yet recruiting NCT06465901 - A Stratified, Multi-ARm, muLti-site Randomised Platform Trial Aiming to Reduce the INcidence of Post-operative SSI N/A
Not yet recruiting NCT04820075 - Efficacy of an Intervention to Improve the Preoperative Shower in Scheduled Surgery N/A
Recruiting NCT03561376 - Zinc Oxide Versus Petrolatum Following Skin Surgery Early Phase 1
Not yet recruiting NCT04496180 - Prevena to Prevent Surgical Site Infection After Emergency Abdominal Laparotomy N/A