Completed

NCT Number: NCT04600310

ULTRAPREP Used to Perform Skin Antisepsis Outside the Operating Room

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.

Completed

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Key information

Conditions

Time Saved Performing Skin Antisepsis Process Outside the OR Antisepsis of Skin Preparation Outside the OR

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

PrepTech, LLC

Westlake, Louisiana, 70669, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

ULTRAPREP

Device

ULTRAPREP device for reducing OR prep times.

No Intervention

Device

Conventional skin preparation technique

Primary outcomes

Change in Time: Room to drape

Time frame: Up to 60 minutes

Minutes elapsed from patient ready for prep and ready for draping
Change in Time: ULTRAPREP bag use

Time frame: Up to 60 minutes

Minutes elapsed from ULTRAPREP placed on extremity to scrubbing complete
Colony forming units (CFU) Pre-Prep 48h

Time frame: 48 hours after collection

CFUs of bacteria per plate, collected upon arrival to pre-op area, measured after 48 hours growth
Colony forming units (CFU) Pre-Prep 72h

Time frame: 72 hours after collection

CFUs of bacteria per plate, collected upon arrival to pre-op area, measured after 72 hours growth
Colony forming units (CFU) Post-Prep 48h

Time frame: 48 hours after collection

CFUs of bacteria per plate, collected prior to draping, measured after 48 hours growth
Colony forming units (CFU) Post-Prep 72h

Time frame: 72 hours after collection

CFUs of bacteria per plate, collected prior to draping, measured after 72 hours growth

Sponsors and collaborators

Lead sponsor

Prep Tech, LLC

Other

Registry information

Official study 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.

Important dates

Study start: 2018
Primary completion: 2019
Study completion: 2019
First posted: Oct 23, 2020
Registry last updated: Oct 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.