WithdrawnPhase 2

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

Stopped: financial reasons

United States0Started 2017-01

Plain-language summary

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

Who can participate

Age range18 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

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.

Timeframe: 30 days

Trial details

NCT IDNCT02617706

SponsorNeogenix, LLC dba Ogenix

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-01

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