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

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

Detailed Description
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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

Official Title
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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

Conditions
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Anorectal Surgeries

Intervention / Treatment
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* Device: Epiflo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Transdermal Continuous Oxygen Therapy<br>EPIFLO® working study unit, all day, every day for 2 - 4 weeks + standard wound care | Device: Epiflo<br>* 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.<br>* Other names: TCOT, Transdermal Continuous Oxygen Therapy;|
| No Intervention: Standard of care<br>standard wound care for 4 weeks | |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anorectal surgeries, infection, topical oxygen