Clinical trial NCT04600310: ULTRAPREP Used to Perform Skin Antisepsis Outside the Operating Room
Official title: A Randomized, Single-blinded Trial to Study the Efficacy, Safety, and Time Saving Using the ULTRAPREP Device With FDA Approved Antisepsis Solution (70% Isopropyl Alcohol and 2% Chlorhexidine) in Preoperative Skin Antisepsis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Time Saved Performing Skin Antisepsis Process Outside the OR
Antisepsis of Skin Preparation Outside the OR
Keywords: skin antisepsis
OR efficiency
Lead sponsor: Prep Tech, LLC
Sponsor class: OTHER
First posted: 2020-10-23
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Testing ULTRAPREP (consists of a clear bag sealed on one end with the other end enclosing the patients extremity) for safety and efficacy to perform skin antisepsis outside the operating room.

Detailed description: The purpose of the study is to determine if ULTRAPREP is equal to or better than the conventional methods of preoperative skin antisepsis (the technique of cleansing the skin to help prevent infection) in surgical cases. The study will also help determine if ULTRAPREP will decrease the total amount of time in the operating room. The study will focus on whether or not using ULTRAPREP provides better patient flow and patient safety while improving a surgical staff's workload and workflow. The study includes 2 study arms:

Study Arm #1: the conventional method (or standard of care) will use an accepted skin disinfectant solution with ChloraPrep (70% isopropyl alcohol and 2% chlorhexidine). The solution is "painted" on the patient's skin using a sponge on a stick. The application time is with this method is 3 minutes plus 3 minutes for solution to evaporate. This is a widely-accepted method used in ORs. The preparation process is performed by surgical staff in the OR prior to surgery.

Study Arm #2: using ULTRAPREP bag containing ChloraPrep (70% isopropyl alcohol and 2% chlorhexidine). The bag will be placed on the patient's lower extremity in the holding area. The lower extremity will be scrubbed for 3 minutes. Once the patient is transferred to the OR, the solution will be suctioned out of the bag and the bag removed from the lower extremity to allow the solution to evaporate, this process take 3 minutes. the patient is then draped for surgery.

This study consists of 57 patients in each arm.

Sterile culture swabs will be taken from toenail beds and between toes or from fingernail beds and between fingers, depending on surgery site. The cultures will be taken preoperative before any disinfecting has begun and just before patient extremity is draped (after allowing 3 minutes for alcohol in disinfectant to evaporate). These sterile swabs will be taken to the lab for aliquot culturing to yield 6 pitre dishes for each swab. The CFUs (colony forming units) from each pitre dish will be counted and analyzed at 48 and 72 hours. A comparison will be made using the cultures in Arm 1 and Arm 2 to determine if the parameters of the study has been met.

Eligibility criteria: Inclusion Criteria:

* 18 or older
* Class 1 clean (as defined by The American College of Surgeons)
* Hand and Feet extremities

Exclusion Criteria:

* Open wounds
* Pregnant
* Emergency surgeries
* Class 2-4 (as defined by The American College of Surgeons)

Primary outcomes:
measure: Change in Time: Room to drape
timeFrame: Up to 60 minutes
measure: Change in Time: ULTRAPREP bag use
timeFrame: Up to 60 minutes
measure: Colony forming units (CFU) Pre-Prep 48h
timeFrame: 48 hours after collection
measure: Colony forming units (CFU) Pre-Prep 72h
timeFrame: 72 hours after collection
measure: Colony forming units (CFU) Post-Prep 48h
timeFrame: 48 hours after collection
measure: Colony forming units (CFU) Post-Prep 72h
timeFrame: 72 hours after collection
Secondary outcomes:
Other outcomes:
Locations:
city: Westlake
country: United States
facility: PrepTech, LLC
state: Louisiana
Study officials:
affiliation: PrepTech, LLC
name: Pete Prados, Business
role: STUDY_DIRECTOR
References: