WithdrawnPhase 2

TCOT Effectiveness in Preventing Wound Infections in Perineal Resections

Stopped: could not come to budget agreement

0Started 2015-09

Plain-language summary

In colorectal surgery, oxygen insufflation (which leads to higher oxygen concentration in the surgical site) has been shown to decrease infection rate. Several pressure wounds in the coccyx have been successfully treated to closure with Transdermal Continuous Oxygen Therapy (TCOT) Given the wound healing properties of TCOT, particularly in infection-prone anatomic locations such as coccyx, and the microbicidal properties of oxygen, it is expected that the infection rate in abdominoperineal (AP) resection surgery can be reduced with transdermal continuous oxygen therapy. The primary objective of this study is to compare the number of surgical site infections associated with perineal surgery within 28 days between subjects randomized to receive EPIFLO or Standard of Care

Who can participate

Age range18 Years – 80 Years

SexALL

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

Inclusion Criteria: * Elective perineal resection, * Patients having abdominal-perineal resections or perineal resections will be included. * Patient age: 18-80 Exclusion Criteria: * • expected surgery time of less than one hour, * fever or existing signs of infection at the time of surgery

What they're measuring

number of surgical site infections

Timeframe: 30 days

Trial details

NCT IDNCT02374294

SponsorNeogenix, LLC dba Ogenix

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2015-09

View on ClinicalTrials.gov More Complication of Surgical Procedure trials