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Prevena™ Incisional Negative Pressure Wound Therapy in Re-operative Colorectal Surgery

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ClinicalTrials.gov Identifier: NCT02509260
Recruitment Status : Completed
First Posted : July 27, 2015
Last Update Posted : May 4, 2021
Sponsor:
Information provided by (Responsible Party):
David Liska, The Cleveland Clinic

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.


Condition or disease Intervention/treatment Phase
Surgical Site Infection Device: Prevena wound management system Other: Standard wound dressings Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 298 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Randomized Controlled Trial of Prevena™ Incisional Negative Pressure Wound Therapy to Reduce Surgical Site Infection in Re-operative Colorectal Surgery
Study Start Date : July 2015
Actual Primary Completion Date : February 19, 2021
Actual Study Completion Date : February 19, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Prevena™ incisional NPWT
Prevena wound management system: Post op application of the Prevena™ wound management system will be applied.
Device: Prevena wound management system
Patients will have the Prevena wound management system applied post-operatively.

Active Comparator: Standard Wound Dressings
Standard Wound Dressings: Control patients with standard wound dressings will have gauze and tape dressings applied.
Other: Standard wound dressings
Control patients with standard wound dressings will have gauze and tape dressings applied




Primary Outcome Measures :
  1. occurrence of superficial surgical site infection [ Time Frame: within 30 days after the operation ]
    Diagnosis will be based on criteria developed by the Centers for Disease Control (CDC)


Secondary Outcome Measures :
  1. length of hospital stay, [ Time Frame: 30 days after operation ]
    number of days in hospital after surgery day

  2. cost effectiveness [ Time Frame: 30 days after operation ]
    ratio of costs between intervention and control group

  3. clinical efficacy of the device in relation to the degree of contamination [ Time Frame: 30 days after operation ]
    difference in SSI between groups



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02509260


Locations
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United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
Investigators
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Principal Investigator: David Liska, MD The Cleveland Clinic
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Responsible Party: David Liska, MD, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT02509260    
Other Study ID Numbers: 15-709
First Posted: July 27, 2015    Key Record Dates
Last Update Posted: May 4, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by David Liska, The Cleveland Clinic:
colorectal surgery
Additional relevant MeSH terms:
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Infection
Surgical Wound Infection
Wound Infection
Postoperative Complications
Pathologic Processes