TCOT Effectiveness in Preventing Wound Infections in Perineal Resections

NCT02374294 | Withdrawn Phase 2 DMC

• 1 other identifier: EPF-614
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

In colorectal surgery, oxygen insufflation (which leads to higher oxygen concentration in the surgical site) has been shown to decrease infection rate. Several pressure wounds in the coccyx have been successfully treated to closure with Transdermal Continuous Oxygen Therapy (TCOT) Given the wound healing properties of TCOT, particularly in infection-prone anatomic locations such as coccyx, and the microbicidal properties of oxygen, it is expected that the infection rate in abdominoperineal (AP) resection surgery can be reduced with transdermal continuous oxygen therapy. The primary objective of this study is to compare the number of surgical site infections associated with perineal surgery within 28 days between subjects randomized to receive EPIFLO or Standard of Care

Conditions

Complication of Surgical Procedure

Outcome Measures

Primary Outcomes (1)

• number of surgical site infections

  number of surgical site infections associated with perineal surgery within 30 days between subjects randomized to receive EPIFLO or Standard of Care.

  30 days

Secondary Outcomes (1)

• resource utilization (duration of time in hospital)

  30 days

Study Arms (2)

Epiflo

EXPERIMENTAL

After the surgery, but before the application of dressing to the surgical site the kit containing the investigation device (and four cannula) is opened. The EPIFLO cannula (sterile package) is opened and applied to the surgical site and sealed with the dressings per protocol. The EPIFLO device is connected to the cannula after making sure the switch is in the ON position.The EPIFLO device is mounted on the patient's body in a convenient location using the Pouch and Arm band provided. At Treatment Visit 3 (Postoperative day #14, +/- 1 day) a new device is given and the old one disposed of. Intermittent dressing changes will take place as needed.

Device: Epiflo

Standard of Care

NO INTERVENTION

After the surgery, but before the application of dressing to the surgical site if upon opening, the kit contains only a weighted block, then, the regular wound dressing protocol, standard of care, will be followed. Intermittent dressing changes will take place as needed.

Interventions

Epiflo DEVICE

EPIFLO: Small, silent disposable, battery-operated oxygen concentrator capable of delivering 98% to 100% oxygen (balance moisture) for seven days at a rate of \~3.0 ml/hour; and 60" long sterile cannula (tube) that conveys the oxygen concentrator to the area beneath the bandage overlying the wound.

Epiflo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Elective perineal resection,
• Patients having abdominal-perineal resections or perineal resections will be included.
• Patient age: 18-80

You may not qualify if:

• expected surgery time of less than one hour,
• fever or existing signs of infection at the time of surgery

Sponsors & Collaborators

• Neogenix, LLC dba Ogenix: lead

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2015
• First Posted: February 27, 2015
• Study Start: September 1, 2015
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: September 30, 2015

Record last verified: 2015-09