Transdermal Continuous Oxygen Therapy for Infection Prophylaxis in High- Risk Patients Undergoing Colon Surgery

A Prospective, Randomized, Parallel Study Comparing Transdermal, Continuous Oxygen Delivery to Standard of Care to Assess Postoperative Wound Infection Rate in Colon and Rectal Resections

EPIFLO® unit along with standard wound care vs only standard wound care for Surgical site infections (SSI).

Study Overview

• Status: Withdrawn
• Conditions: Anorectal Surgeries
• Intervention / Treatment: Device: Epiflo

Detailed Description

Anorectal procedures more often lead to surgical site infections. Such infections are unfortunately frequent and can be difficult for the patient and the treating physician. Wound hypoxia has been identified as a pathogenic mechanism behind wound infection and poor healing. Transdermal oxygen delivery (EPIFLO) is intended to promote the healing process in chronic wounds as an adjunct to standard wound care in wound management and treatment

• Study Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15212
      • Department of General Surgery Allegheny General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Elective colo-rectal surgery with or without anastomosis and with or without stoma
• Patient age: 18-80

Exclusion Criteria:

• Pregnancy

  • Anesthesiology ASA score of 4 or above
  • fever or existing signs of infection at the time of surgery
  • Diabetes Mellitus type I or II with HbA1C level 12% or more
  • Persons with decubitus or diabetic ulcers
  • Subjects with peritoneal metastases
  • Patients with severe malnutrition as indicated by Prealbumin value of <20
  • BMI ≥50

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Transdermal Continuous Oxygen Therapy; EPIFLO® working study unit, all day, every day for 2 - 4 weeks + standard wound care	Device: Epiflo; Transdermal continuous oxygen therapy is oxygen delivery to the wound site directly. Ogenix makes a small portable oxygen concentrator (Trade Name: EPIFLO) that makes continuous transdermal delivery of oxygen possible. It is a 3 ounce oxygen generator that continuously delivers 3 ml of pure oxygen to the wound site.; Other Names: TCOT, Transdermal Continuous Oxygen Therapy
No Intervention: Standard of care; standard wound care for 4 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with surgical site infections measured with the Southampton Scoring System. The number of subjects with infection of the surgical site will be compared using chi-square or Fisher Exact test.	The primary objective of this study is to assess surgical site infection within 30 days of surgery for "high risk" patients undergoing colo-rectal surgery in patients receiving adjunct Transdermal Continuous Oxygen therapy vs. standard of care control Measures as either yes infection or no infection	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severity of infection measured with the Southampton Scoring System	Severity of infection using Southampton Scoring System. To maintain the trial-wise Type I error rate at 0.05, a closed test procedure will be used for the secondary endpoints	30 days
Number of days until patients surgical site is healed	Time to heal. To maintain the trial-wise Type I error rate at 0.05, a closed test procedure will be used for the secondary endpoints	30 days
Resource utilization - cost of treatments, hospital stays, bandages, nursing care	Resource utilization - cost of treatments, hospital stays, bandages, nursing care all measured in dollar amounts and then summed	30 days

Collaborators and Investigators

• Sponsor: Neogenix, LLC dba Ogenix
• Investigators: Study Director: Sarang Sarangapani, Ph.D., Neogenix,LLC

Study record dates

Study Major Dates

• Study Start: January 1, 2017
• Primary Completion (Anticipated): January 1, 2018
• Study Completion (Anticipated): January 1, 2019

Study Registration Dates

• First Submitted: November 18, 2015
• First Submitted That Met QC Criteria: November 25, 2015
• First Posted (Estimate): December 1, 2015

Study Record Updates

• Last Update Posted (Actual): August 14, 2017
• Last Update Submitted That Met QC Criteria: August 10, 2017
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: infection; topical oxygen; Anorectal surgeries
• Additional Relevant MeSH Terms: Infections
• Other Study ID Numbers: EPF-615