MedTrace Logo

TCOT Effectiveness in Preventing Wound Infections in Perineal Resections

NCT02374294 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2015-09-30

No results posted yet for this study

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

Conditions

  • Complication of Surgical Procedure

Interventions

DEVICE

Epiflo

EPIFLO: Small, silent disposable, battery-operated oxygen concentrator capable of delivering 98% to 100% oxygen (balance moisture) for seven days at a rate of \~3.0 ml/hour; and 60" long sterile cannula (tube) that conveys the oxygen concentrator to the area beneath the bandage overlying the wound.

Sponsors & Collaborators

  • Neogenix, LLC dba Ogenix

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2015-09-30
Completion
2015-09-30

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02374294 on ClinicalTrials.gov