Transdermal Continuous Oxygen Therapy for Infection Prophylaxis in High- Risk Patients Undergoing Colon and Rectal Resections
| Status: | Not yet recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 4/21/2016 |
| Start Date: | January 2016 |
| Contact: | Sarang Sarangapani |
| Email: | ssarangapani@ogenix.com |
| Phone: | 78170209732 |
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
EPIFLO® unit along with standard wound care vs only standard wound care for Surgical site
infections (SSI).
infections (SSI).
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
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
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
We found this trial at
1
site
Pittsburgh, Pennsylvania 15212
Principal Investigator: James McCormick, D.O.
Phone: 412-359-3901
Click here to add this to my saved trials
