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

NCT02509260 | Completed Results

• 1 other identifier: 15-709
• Study Type: interventional
• Target: 298
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgical Site Infection

Keywords

colorectal surgery

Outcome Measures

Primary Outcomes (1)

• Occurrence of Superficial Surgical Site Infection

  Diagnosis will be based on criteria developed by the Centers for Disease Control (CDC)

  within 30 days after the operation

Secondary Outcomes (3)

• Length of Hospital Stay,

  30 days after operation

• Cost Effectiveness

  30 days after operation

• Clinical Efficacy of the Device in Relation to the Degree of Contamination

  30 days after operation

Study Arms (2)

Prevena™ incisional NPWT

EXPERIMENTAL

Prevena wound management system: Post op application of the Prevena™ wound management system will be applied.

Device: Prevena wound management system

Standard Wound Dressings

ACTIVE COMPARATOR

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

Other: Standard wound dressings

Interventions

Prevena wound management system DEVICE

Patients will have the Prevena wound management system applied post-operatively.

Prevena™ incisional NPWT

Standard wound dressings OTHER

Control patients with standard wound dressings will have gauze and tape dressings applied

Standard Wound Dressings

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age
• re-operative colorectal surgery
• excision or revision of prior anastomosis
• intestinal resection
• incisional hernia repair
• enterocutaneous fistula repair
• emergency settings

You may not qualify if:

• Laparoscopic or laparoscopic assisted procedures
• patients who had undergone a laparotomy within the preceding three months
• an active SSI at the time of surgery

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Related Publications (1)

• Sapci I, Camargo M, Duraes L, Jia X, Hull TL, Ashburn J, Valente MA, Holubar SD, Delaney CP, Gorgun E, Steele SR, Liska D. Effect of Incisional Negative Pressure Wound Therapy on Surgical Site Infections in High-Risk Reoperative Colorectal Surgery: A Randomized Controlled Trial. Dis Colon Rectum. 2023 Feb 1;66(2):306-313. doi: 10.1097/DCR.0000000000002415. Epub 2022 Apr 1.

  PMID: 35358097 DERIVED

MeSH Terms

Conditions

Surgical Wound Infection

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. David Liska
• Organization: Cleveland Clinic Foundation

liskad@ccf.org

1-216-444-9219

Study Officials

• David Liska, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: July 24, 2015
• First Posted: July 27, 2015
• Study Start: July 1, 2015
• Primary Completion: February 19, 2021
• Study Completion: February 19, 2021
• Last Updated: November 14, 2022
• Results First Posted: November 14, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)