Skip to content

ULTRAPREP Used to Perform Skin Antisepsis Outside the Operating Room

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.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04600310
Enrollment
114
Registered
2020-10-23
Start date
2018-04-17
Completion date
2019-01-17
Last updated
2020-10-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

skin antisepsis, OR efficiency

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.

Interventions

DEVICEULTRAPREP

ULTRAPREP device for reducing OR prep times.

DEVICENo Intervention

Conventional skin preparation technique

Sponsors

Prep Tech, LLC
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Change in Time: Room to drapeUp to 60 minutesMinutes elapsed from patient ready for prep and ready for draping
Change in Time: ULTRAPREP bag useUp to 60 minutesMinutes elapsed from ULTRAPREP placed on extremity to scrubbing complete
Colony forming units (CFU) Pre-Prep 48h48 hours after collectionCFUs of bacteria per plate, collected upon arrival to pre-op area, measured after 48 hours growth
Colony forming units (CFU) Pre-Prep 72h72 hours after collectionCFUs of bacteria per plate, collected upon arrival to pre-op area, measured after 72 hours growth
Colony forming units (CFU) Post-Prep 48h48 hours after collectionCFUs of bacteria per plate, collected prior to draping, measured after 48 hours growth
Colony forming units (CFU) Post-Prep 72h72 hours after collectionCFUs of bacteria per plate, collected prior to draping, measured after 72 hours growth

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026