Prevena™ Incisional Negative Pressure Wound Therapy in Re-operative Colorectal Surgery
Primary Purpose
Surgical Site Infection
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Prevena wound management system
Standard wound dressings
Sponsored by
About this trial
This is an interventional prevention trial for Surgical Site Infection focused on measuring colorectal surgery
Eligibility Criteria
Inclusion Criteria:
- 18 years of age
- re-operative colorectal surgery
- excision or revision of prior anastomosis
- intestinal resection
- incisional hernia repair
- enterocutaneous fistula repair
- emergency settings
Exclusion Criteria:
- Laparoscopic or laparoscopic assisted procedures
- patients who had undergone a laparotomy within the preceding three months
- an active SSI at the time of surgery
Sites / Locations
- Cleveland Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Prevena™ incisional NPWT
Standard Wound Dressings
Arm Description
Prevena wound management system: Post op application of the Prevena™ wound management system will be applied.
Standard Wound Dressings: Control patients with standard wound dressings will have gauze and tape dressings applied.
Outcomes
Primary Outcome Measures
Occurrence of Superficial Surgical Site Infection
Diagnosis will be based on criteria developed by the Centers for Disease Control (CDC)
Secondary Outcome Measures
Length of Hospital Stay,
number of days in hospital after surgery day
Cost Effectiveness
ratio of costs between intervention and control group
Clinical Efficacy of the Device in Relation to the Degree of Contamination
difference in SSI between groups
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02509260
Brief Title
Prevena™ Incisional Negative Pressure Wound Therapy in Re-operative Colorectal Surgery
Official Title
A Randomized Controlled Trial of Prevena™ Incisional Negative Pressure Wound Therapy to Reduce Surgical Site Infection in Re-operative Colorectal Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
July 2015 (undefined)
Primary Completion Date
February 19, 2021 (Actual)
Study Completion Date
February 19, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Cleveland Clinic
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Many strategies have been attempted to reduce SSI rates. The Centers for Medicare and Medicaid Services introduced the Surgical Care Improvement Project infection project with the aim of reducing SSI incidence and morbidity. These measures include prophylactic intravenous antibiotics administered within 1 hour of skin incision, appropriate prophylactic antibiotic selection, discontinuation of prophylactic antibiotics within 24 hours after surgery, appropriate hair removal, and maintenance of perioperative normothermia. Despite the enforcement of these measures through quality reporting and pay-for-performance measures, significant controversy exists as to their overall effectiveness, especially in the high-risk colorectal surgical population. Laparoscopic surgery has been shown to improve SSI rates in the colorectal population; however, not all patients are appropriate candidates for this approach and the inability of promising interventions such as wound edge protection and gentamicin sponges to improve SSI rates following colorectal surgery mandate the investigation of novel techniques.
The aim of the current study is to assess the clinical effectiveness of incisional NPWT to reduce SSI rates in open, re-operative colorectal surgery. The primary endpoint of this study is the occurrence of superficial SSI within 30 days after surgery and the secondary endpoints include length of hospital stay and cost effectiveness.
Detailed Description
Surgical site infections (SSIs) are a common problem and a significant cause of morbidity in surgical patients. They present a substantial burden to the health care system in the United States and contribute more than 1.6 billion dollars in excess cost and 1 million in extra hospital days in affected patients. SSIs are associated with a multitude of complications including an increased risk of incisional hernia and prolonged hospital stay. Despite optimum surgical care there remains an inability to significantly reduce SSI rates following colorectal surgery and this field represents a critical priority for study. When one examines the control arms of recent high quality randomized controlled trials, the SSI rate following colorectal surgery ranges from 22.0-26.1%, emphasizing the prevalence of this complication.
Many strategies have been attempted to reduce SSI rates. The Centers for Medicare and Medicaid Services introduced the Surgical Care Improvement Project infection project with the aim of reducing SSI incidence and morbidity. These measures include prophylactic intravenous antibiotics administered within 1 hour of skin incision, appropriate prophylactic antibiotic selection, discontinuation of prophylactic antibiotics within 24 hours after surgery, appropriate hair removal, and maintenance of perioperative normothermia. Despite the enforcement of these measures through quality reporting and pay-for-performance measures, significant controversy exists as to their overall effectiveness, especially in the high-risk colorectal surgical population. Laparoscopic surgery has been shown to improve SSI rates in the colorectal population; however, not all patients are appropriate candidates for this approach and the inability of promising interventions such as wound edge protection6 and gentamicin sponges4 to improve SSI rates following colorectal surgery mandate the investigation of novel techniques.
Initiated in the orthopaedic literature, a new technique of wound dressing has been described to reduce SSI. Incisional negative pressure wound therapy (NPWT) using devices such as the Prevena™ involves applying a wound vacuum sponge over a standard wound closure (including fascial closure and skin closure with staples). The incisional NPWT dressing is then left in place for 5 to 7 days before removal. A recent retrospective study by Bonds et al. described the ability of incisional NPWT to reduce SSI rates in open colorectal surgery from 29.3-12.5%.
The aim of the current study is to assess the clinical effectiveness of incisional NPWT to reduce SSI rates in open, re-operative colorectal surgery. The primary endpoint of this study is the occurrence of superficial SSI within 30 days after surgery and the secondary endpoints include, length of hospital stay and cost effectiveness.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Site Infection
Keywords
colorectal surgery
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
298 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Prevena™ incisional NPWT
Arm Type
Experimental
Arm Description
Prevena wound management system: Post op application of the Prevena™ wound management system will be applied.
Arm Title
Standard Wound Dressings
Arm Type
Active Comparator
Arm Description
Standard Wound Dressings: Control patients with standard wound dressings will have gauze and tape dressings applied.
Intervention Type
Device
Intervention Name(s)
Prevena wound management system
Intervention Description
Patients will have the Prevena wound management system applied post-operatively.
Intervention Type
Other
Intervention Name(s)
Standard wound dressings
Intervention Description
Control patients with standard wound dressings will have gauze and tape dressings applied
Primary Outcome Measure Information:
Title
Occurrence of Superficial Surgical Site Infection
Description
Diagnosis will be based on criteria developed by the Centers for Disease Control (CDC)
Time Frame
within 30 days after the operation
Secondary Outcome Measure Information:
Title
Length of Hospital Stay,
Description
number of days in hospital after surgery day
Time Frame
30 days after operation
Title
Cost Effectiveness
Description
ratio of costs between intervention and control group
Time Frame
30 days after operation
Title
Clinical Efficacy of the Device in Relation to the Degree of Contamination
Description
difference in SSI between groups
Time Frame
30 days after operation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18 years of age
re-operative colorectal surgery
excision or revision of prior anastomosis
intestinal resection
incisional hernia repair
enterocutaneous fistula repair
emergency settings
Exclusion Criteria:
Laparoscopic or laparoscopic assisted procedures
patients who had undergone a laparotomy within the preceding three months
an active SSI at the time of surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Liska, MD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Prevena™ Incisional Negative Pressure Wound Therapy in Re-operative Colorectal Surgery
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