Study Stopped
financial reasons
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
1 other identifier
interventional
N/A
1 country
1
Brief Summary
EPIFLO® unit along with standard wound care vs only standard wound care for Surgical site infections (SSI).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jan 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 18, 2015
CompletedFirst Posted
Study publicly available on registry
December 1, 2015
CompletedStudy Start
First participant enrolled
January 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2019
CompletedAugust 14, 2017
October 1, 2016
1 year
November 18, 2015
August 10, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Severity of infection measured with the Southampton Scoring System
30 days
Number of days until patients surgical site is healed
30 days
Resource utilization - cost of treatments, hospital stays, bandages, nursing care
30 days
Study Arms (2)
Transdermal Continuous Oxygen Therapy
EXPERIMENTALEPIFLO® working study unit, all day, every day for 2 - 4 weeks + standard wound care
Standard of care
NO INTERVENTIONstandard wound care for 4 weeks
Interventions
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.
Eligibility Criteria
You may qualify if:
- Elective colo-rectal surgery with or without anastomosis and with or without stoma
- Patient age: 18-80
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of General Surgery Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212, United States
MeSH Terms
Conditions
Study Officials
- STUDY DIRECTOR
Sarang Sarangapani, Ph.D.
Neogenix,LLC
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
November 18, 2015
First Posted
December 1, 2015
Study Start
January 1, 2017
Primary Completion
January 1, 2018
Study Completion
January 1, 2019
Last Updated
August 14, 2017
Record last verified: 2016-10