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

Primary Purpose

Anorectal Surgeries

Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Epiflo
Sponsored by
Neogenix, LLC dba Ogenix
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Anorectal Surgeries focused on measuring Anorectal surgeries, infection, topical oxygen

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of General Surgery Allegheny General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Transdermal Continuous Oxygen Therapy

Standard of care

Arm Description

EPIFLO® working study unit, all day, every day for 2 - 4 weeks + standard wound care

standard wound care for 4 weeks

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
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

Full Information

First Posted
November 18, 2015
Last Updated
August 10, 2017
Sponsor
Neogenix, LLC dba Ogenix
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1. Study Identification

Unique Protocol Identification Number
NCT02617706
Brief Title
Transdermal Continuous Oxygen Therapy for Infection Prophylaxis in High- Risk Patients Undergoing Colon Surgery
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Withdrawn
Why Stopped
financial reasons
Study Start Date
January 2017 (undefined)
Primary Completion Date
January 2018 (Anticipated)
Study Completion Date
January 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Neogenix, LLC dba Ogenix

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anorectal Surgeries
Keywords
Anorectal surgeries, infection, topical oxygen

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Transdermal Continuous Oxygen Therapy
Arm Type
Experimental
Arm Description
EPIFLO® working study unit, all day, every day for 2 - 4 weeks + standard wound care
Arm Title
Standard of care
Arm Type
No Intervention
Arm Description
standard wound care for 4 weeks
Intervention Type
Device
Intervention Name(s)
Epiflo
Other Intervention Name(s)
TCOT, Transdermal Continuous Oxygen Therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
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.
Description
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
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Severity of infection measured with the Southampton Scoring System
Description
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
Time Frame
30 days
Title
Number of days until patients surgical site is healed
Description
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
Time Frame
30 days
Title
Resource utilization - cost of treatments, hospital stays, bandages, nursing care
Description
Resource utilization - cost of treatments, hospital stays, bandages, nursing care all measured in dollar amounts and then summed
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarang Sarangapani, Ph.D.
Organizational Affiliation
Neogenix,LLC
Official's Role
Study Director
Facility Information:
Facility Name
Department of General Surgery Allegheny General Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States

12. IPD Sharing Statement

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

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