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

NCT ID: NCT02617706

Last Updated: 2017-08-14

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-31
• Study Completion Date: 2019-01-31

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

Conditions

Anorectal Surgeries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Transdermal Continuous Oxygen Therapy

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

Group Type: EXPERIMENTAL

Epiflo

Intervention Type: DEVICE

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.

Standard of care

standard wound care for 4 weeks

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

TCOT, Transdermal Continuous Oxygen Therapy

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Neogenix, LLC dba Ogenix

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sarang Sarangapani, Ph.D.

Role: STUDY_DIRECTOR

Neogenix,LLC

Locations

Department of General Surgery Allegheny General Hospital

Pittsburgh, Pennsylvania, United States

Countries

United States

Other Identifiers

EPF-615

Identifier Type: -

Identifier Source: org_study_id