Complication of Surgical Procedure Clinical Trial
Official title:
A Prospective, Randomized, Parallel Study Comparing Transdermal, Continuous Oxygen Therapy (TCOT) to Standard of Care to Assess Postoperative Wound Infection Rate in Perineal Resections
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
EPIFLO is a 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.
The primary objective of this study is to compare the number of surgical site infections
associated with perineal surgery within 30 days between subjects randomized to receive
EPIFLO or Standard of Care. Secondary Study objectives include Resource utilization and
duration of hospitalization.
Hypothesis 1: The proportion of surgical site infections will be lower for patients treated
with Transdermal Continuous Oxygen Therapy (TCOT) Hypothesis 2: In the patients who develop
infections, wounds will be smaller and heal more rapidly in those treated with Transdermal
Continuous Oxygen Therapy.
Key Safety Assessments Include potential dermatological toxicity changes attributed to
EPIFLO as measured by observed and reported discomfort and changes in skin during and after
the Treatment Period (It is essential to establish the difference between toxicity from the
dressing vs. toxicity arising out of EPIFLO).
This Study will be a randomized controlled trial of 30 patients aged 18-80 years who are
scheduled to undergo elective perineal resection surgery at the University of Maryland
Medical Center. This study is designed to be a Phase II safety & efficacy study. Patients
who met the inclusion/exclusion criteria will be randomized to receive the interventional
device with Standard of Care or Standard of Care only (1:1). The patients will be equally
divided between the two arms. Sham devices are not involved in this study. Wound infections
will be diagnosed by the investigator using Centers for Disease Control and Prevention
Criteria. As an additional measure to prevent bias, the pictures of the wounds may be sent
to an independent clinical specialist for assessment of infection; this specialist will be
blinded to get an objective opinion.
The expected time on study is 1 month ( 27-30 days). This does not include screening period
which occurs when the subject consents to be in the study (signs the informed consent) to
when they have their surgery (day 1). The screening period can be up to 28 days. While in
the study, there are four study visits: Visit 1 day 1 is the day of the surgery, and
randomization. The second study visit will be the day of the post surgery discharge (day
3-5). The third study visit will be 14 days following surgery, (day 14) and the Final study
visit will be the day of the post surgical follow up visit (day 28). The total treatment
period may be 14 or 28 days. After 14-days of treatment, if the wound is completely healed,
the treatment phase is complete. If the wound is not completely healed they will receive an
additional 14 days of treatment. Either way the patient's healing progress will be followed
for a total study duration of 30 days.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT02789579 -
The Preventive Infection Role of One Week Antibiotics Before Minimally Invasive Upper Tract Lithotomy
|
Early Phase 1 | |
Completed |
NCT02252562 -
Hand Hygiene and Hospital Acquired Infections
|
N/A | |
Completed |
NCT01757704 -
Factors Responsible for the Effectiveness of the Lund De-airing Technique
|
N/A | |
Recruiting |
NCT05005117 -
Laparoscopic Approach for Emergency Colon Resection
|
N/A | |
Enrolling by invitation |
NCT03234543 -
Remote Ischemic Conditioning in Abdominal Surgery
|
N/A | |
Completed |
NCT04849702 -
Comparison of the Clavien-Dindo and Comprehensive Complication Index
|
||
Completed |
NCT04120324 -
Incidence of 30 Day Return to Hospital Following Same Day Discharge Total Hip Arthroplasty
|
||
Not yet recruiting |
NCT06199401 -
Safety and Efficacy of XJ-Procedure in Patients With Acute Type A Aortic Dissection Surgery
|
N/A | |
Recruiting |
NCT05761821 -
Key Factors of Leadless Pacemaker Implantation With Implantation Site, Complications and Prognosis
|
||
Active, not recruiting |
NCT05795127 -
Risk for Reoperation After First MTP Joint Arthrodesis
|
||
Completed |
NCT04550156 -
Evaluation of the Introduction of a Colorectal Bundle in Left Sided Colorectal Resections
|
N/A | |
Recruiting |
NCT05194943 -
Trends and Safety in Revisional Bariatric Surgery in Italy
|
||
Not yet recruiting |
NCT03313986 -
Outcomes of Surgical Correction of Penile Curvature in Adult
|
N/A | |
Enrolling by invitation |
NCT04456530 -
Use of Testosterone to Prevent Post-Surgical Muscle Loss - Pilot Study
|
Phase 2/Phase 3 | |
Completed |
NCT03125798 -
Comparison of LigaSure to Conventional Electrocoagulation in Video-assisted Thoracoscopic Surgery Lobectomy
|
N/A | |
Completed |
NCT04226482 -
Review of Efficacy of Used ultraSonic Energy Device
|
N/A | |
Completed |
NCT01739374 -
Efficacy and Safety of Reduced Pelvic Floor Mesh Implants
|
Phase 2/Phase 3 | |
Completed |
NCT01346709 -
Prospective Evaluation of a RIsk Score for Postoperative Pulmonary COmPlications in Europe
|
||
Enrolling by invitation |
NCT06394908 -
Registry of MIUS for Urolithiasis (ReMIUS-U)
|
||
Recruiting |
NCT02212054 -
A Trial on Treatments of Hirschsprung Allied Disease
|
N/A |