- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02299752
Unnoticed Gloves Perforation
November 20, 2014 updated by: Lukasz Szarpak, International Institute of Rescue Research and Education
Double Gloves: A Randomized Trial to Evaluate a Simple Strategy to Reduce Contamination During Resuscitation
The aim of the study was to investigate the incidence of glove perforation in cannulation of blood vessels (CBV) during resuscitation and compare perforation rates between single and double-gloves.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
Exposure to blood pathogens among medical staff is a serious problem that should be first and foremost prevented .
The risk of acquiring a virus from one percutaneous needle stick is 0.3% to 0.4% for human immunodeficiency virus (HIV), 6% to 30% for hepatitis B (HBV), and 2.7% to 10% for hepatitis C (HCV).
The prevention of blood-borne infections is particularly important during cases when emergency medical attention is needed.
Emergency Response Personnel that work in this profession have taken medical rescue courses to prepare for situations of sudden health threats, hence the majority of procedures is associated with direct contact with body fluids of the patient.
Study Type
Interventional
Enrollment (Anticipated)
200
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Masovia
-
Warsaw, Masovia, Poland, 03-122
- Recruiting
- International Institute of Rescue Research and Education
-
Contact:
- Lukasz Czyżewski
- Phone Number: 725993850
- Email: rn.czyzewski@gmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Give voluntary consent to participate in the study
- Medical profession (paramedics, nurses, physicians) or medical students (nurses, paramedics, physicians)
Exclusion Criteria:
- Not meet the above criteria
- Wrist or low back diseases
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Catheterization
Blood vessel Catheterization during resuscitation with single and double - gloving system.
Catheterization was performed using simulation mannikin
|
single-gloving system was used during Catheterization
double-gloving system was used during Catheterization.
inner and outer gloves were the same size
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
visible puncture
Time Frame: 1 day
|
Checking gloves for visible damage in the course of cannulation during resuscitation
|
1 day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
WLT
Time Frame: 1 day
|
Water leak test was used to checking unnoticed gloves damage
|
1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2014
Primary Completion (Anticipated)
December 1, 2014
Study Completion (Anticipated)
December 1, 2014
Study Registration Dates
First Submitted
November 13, 2014
First Submitted That Met QC Criteria
November 20, 2014
First Posted (Estimate)
November 24, 2014
Study Record Updates
Last Update Posted (Estimate)
November 24, 2014
Last Update Submitted That Met QC Criteria
November 20, 2014
Last Verified
November 1, 2014
More Information
Terms related to this study
Other Study ID Numbers
- Gloves/2014/01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Catheterization
-
Qilu Hospital of Shandong UniversityUnknownCatheterization, Peripheral | Catheterization, Central VenousChina
-
Solventum US LLCUniversity of Nebraska; 3MCompletedCatheterization
-
Becton, Dickinson and CompanyCompleted
-
University of PittsburghNational Institutes of Health (NIH)CompletedCatheterizationUnited States
-
University of PittsburghNational Institutes of Health (NIH)CompletedCatheterizationUnited States
-
Wellspect HealthCareCompletedCatheterization (Clean, Intermittent Urinary Catheterization)Sweden
-
University of PadovaRecruitingEpidural CatheterizationItaly
-
Associazione per lo Studio delle Malattie Cardiovascolari...RecruitingCoronary CatheterizationBelgium, Italy
Clinical Trials on single-gloving system
-
Seoul National University HospitalCompleted
-
VA Office of Research and DevelopmentUniversity of Wisconsin, MadisonCompletedClostridium DifficileUnited States
-
Virginia Commonwealth UniversityCompletedPersonal Protective EquipmentUnited States
-
Mansoura UniversityCompleted
-
University of Texas Southwestern Medical CenterCompleted
-
Vanderbilt University Medical CenterIntuitive SurgicalRecruitingDIEP Flap Breast ReconstructionUnited States
-
Minia UniversityCompleted
-
Coloplast A/SCompletedStress Urinary IncontinenceSpain, France, Italy, Germany, Netherlands
-
Boehringer IngelheimCompletedPulmonary Disease, Chronic ObstructiveNetherlands
-
Second Affiliated Hospital of Wenzhou Medical UniversityNot yet recruitingOvarian Cysts | Ovarian Diseases | Adnexal Diseases | Uterine Fibroids | Adnexal Mass | Adenopathy | Adnexal CystChina