Anorectal Surgeries
Conditions
Keywords
Anorectal surgeries, infection, topical oxygen
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
Interventions
DEVICEEpiflo
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.
Sponsors
Neogenix, LLC dba Ogenix
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 30 days | 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
| Measure | Time frame | Description |
|---|---|---|
| Severity of infection measured with the Southampton Scoring System | 30 days | 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 | 30 days | 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 | 30 days | Resource utilization - cost of treatments, hospital stays, bandages, nursing care all measured in dollar amounts and then summed |
Countries
United States
Outcome results
None listed