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

Anorectal Surgeries Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02617706
• Other study ID #: EPF-615
• Status: Withdrawn
• Phase: Phase 2
• First received: November 18, 2015
• Last updated: August 10, 2017
• Start date: January 2017
• Est. completion date: January 2019

Study information

• Verified date: October 2016
• Source: Neogenix, LLC dba Ogenix
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2019
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Anorectal Surgeries
• Infection

Intervention

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.

Locations

Country	Name	City	State
United States	Department of General Surgery Allegheny General Hospital	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Neogenix, LLC dba Ogenix

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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