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

Neogenix (Ogenix)

Status and phase: Withdrawn; Phase 2

Conditions: Anorectal Surgeries

Treatments: Device: Epiflo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02617706

EPF-615

Details and patient eligibility

About

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

Full 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

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Transdermal Continuous Oxygen Therapy

Experimental group

Description:

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

Treatment:

Device: Epiflo

Standard of care

No Intervention group

Description:

standard wound care for 4 weeks