Time Saved Performing Skin Antisepsis Process Outside the ORNCT04600310
ULTRAPREP Used to Perform Skin Antisepsis Outside the Operating Room
A study testing ULTRAPREP in people with Time Saved Performing Skin Antisepsis Process Outside the OR and Antisepsis of Skin Preparation Outside the OR, run by Prep Tech, LLC at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Time Saved Performing Skin Antisepsis Process Outside the OR, Antisepsis of Skin Preparation Outside the OR
- What is being tested?
- ULTRAPREP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Apr 2018to 17 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 or older
- Class 1 clean (as defined by The American College of Surgeons)
- Hand and Feet extremities
Who cannot join
- Open wounds
- Pregnant
- Emergency surgeries
- Class 2-4 (as defined by The American College of Surgeons)
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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.
- Conditions
- Time Saved Performing Skin Antisepsis Process Outside the OR, Antisepsis of Skin Preparation Outside the OR
- Being tested
- ULTRAPREP, No Intervention
- Keywords
- skin antisepsis, OR efficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ULTRAPREPDevice
ULTRAPREP device for reducing OR prep times.
No InterventionDevice
Conventional skin preparation technique
| Study group | Role | What they receive |
|---|---|---|
| Study Arm 1 Conventional Prep/Control | Other | The preoperative preparation for the control group will use ChloraPrep (2% chlorhexidine and 70% isopropyl alcohol) that will be applied to the skin using a sponge-on-a-stick method; this solution is widely recognized as optimal. After the alcohol-based solution has evaporated (no less than 3 minutes), the patient extremity is draped for surgery. Receives: Device: No Intervention |
| Study Arm 2 ULTRAPREP Group/Intervention Arm | Other | ChloraPrep (2% chlorhexidine and 70% isopropyl alcohol) will be poured into the ULTRAPREP bag which will be placed on the patient's extremity while in the holding area; it will be removed only after scrub time of 3 minutes is complete and the patient has been transferred to the OR, anesthetized, and positioned. The patient is draped only after the solution has evaporated (no less than 3 minutes). Receives: Device: ULTRAPREP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Time: Room to drape
Minutes elapsed from patient ready for prep and ready for draping
Measured: Up to 60 minutes
Change in Time: ULTRAPREP bag use
Minutes elapsed from ULTRAPREP placed on extremity to scrubbing complete
Measured: Up to 60 minutes
Colony forming units (CFU) Pre-Prep 48h
CFUs of bacteria per plate, collected upon arrival to pre-op area, measured after 48 hours growth
Measured: 48 hours after collection
Colony forming units (CFU) Pre-Prep 72h
CFUs of bacteria per plate, collected upon arrival to pre-op area, measured after 72 hours growth
Measured: 72 hours after collection
Colony forming units (CFU) Post-Prep 48h
CFUs of bacteria per plate, collected prior to draping, measured after 48 hours growth
Measured: 48 hours after collection
Colony forming units (CFU) Post-Prep 72h
CFUs of bacteria per plate, collected prior to draping, measured after 72 hours growth
Measured: 72 hours after collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2020
- Study start17 Apr 2018
- Primary completion17 Jan 2019
- Study completion17 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Time Saved Performing Skin Antisepsis Process Outside the ORStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prep Tech, LLC
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mallory M. Przybylski, DPM, MSc, Prep Tech, LLC
- Investigators
- Pete Prados, Business, Study director, PrepTech, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04600310
- Sponsor's protocol ID
- ULTRAPREP-100
- Status last verified
- Oct 2020
- First submitted
- 29 Sep 2020
- Last updated
- 23 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04600310
- Acronym / sponsor ID
- ULTRAPREP-100
- Conditions
- Time Saved Performing Skin Antisepsis Process Outside the OR, Antisepsis of Skin Preparation Outside the OR
- Keywords
- skin antisepsis, OR efficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Prep Tech, LLCUniversity, hospital or other
- Study start
- 17 Apr 2018 (actual)
- Primary completion
- 17 Jan 2019 (actual)
- Study completion
- 17 Jan 2019 (actual)
- First posted
- 23 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Arm 1 Conventional Prep/Control | Other | Device: No InterventionThe preoperative preparation for the control group will use ChloraPrep (2% chlorhexidine and 70% isopropyl alcohol) that will be applied to the skin using a sponge-on-a-stick method; this solution is widely recognized as optimal. After the alcohol-based solution has evaporated (no less than 3 minutes), the patient extremity is draped for surgery. |
| Study Arm 2 ULTRAPREP Group/Intervention Arm | Other | Device: ULTRAPREPChloraPrep (2% chlorhexidine and 70% isopropyl alcohol) will be poured into the ULTRAPREP bag which will be placed on the patient's extremity while in the holding area; it will be removed only after scrub time of 3 minutes is complete and the patient has been transferred to the OR, anesthetized, and positioned. The patient is draped only after the solution has evaporated (no less than 3 minutes). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 or older
- Class 1 clean (as defined by The American College of Surgeons)
- Hand and Feet extremities
Key exclusion criteria (4 listed)
- Open wounds
- Pregnant
- Emergency surgeries
- Class 2-4 (as defined by The American College of Surgeons)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ULTRAPREPULTRAPREP device for reducing OR prep times. | Device | Study Arm 2 ULTRAPREP Group/Intervention Arm |
| No InterventionConventional skin preparation technique | Device | Study Arm 1 Conventional Prep/Control |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2020.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pete Prados, Business study director
PrepTech, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ULTRAPREP in people with Time Saved Performing Skin Antisepsis Process Outside the OR and Antisepsis of Skin Preparation Outside the OR, run by Prep Tech, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Time: Room to drape (time frame: Up to 60 minutes). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2020.