Unnoticed Gloves Perforation

Catheterization Clinical Trial

Official title:

Double Gloves: A Randomized Trial to Evaluate a Simple Strategy to Reduce Contamination During Resuscitation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02299752
• Other study ID #: Gloves/2014/01
• Status: Recruiting
• Phase: N/A
• First received: November 13, 2014
• Last updated: November 20, 2014
• Start date: November 2014
• Est. completion date: December 2014

Study information

• Verified date: November 2014
• Source: International Institute of Rescue Research and Education
• Contact: Andrzej Kurowski
• Phone: +48500186225
• Email: andrzejkurowski987[@]gmail.com
• Is FDA regulated: No
• Health authority: Poland: Ministry of Science and Higher Education
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Catheterization
• Contamination

Intervention

Procedure:
• single-gloving system
single-gloving system was used during Catheterization
• double-gloving system
double-gloving system was used during Catheterization. inner and outer gloves were the same size

Locations

Country	Name	City	State
Poland	International Institute of Rescue Research and Education	Warsaw	Masovia

Sponsors (1)

Lead Sponsor	Collaborator
International Institute of Rescue Research and Education

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	visible puncture	Checking gloves for visible damage in the course of cannulation during resuscitation	1 day	No
Secondary	WLT	Water leak test was used to checking unnoticed gloves damage	1 day	No