Unnoticed Gloves Perforation

• Sponsor: International Institute of Rescue Research and Education (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02299752
• Collaborator: (none)
• Enrollment: 200
• Location: 1
• Arm: 1
• Duration (Days): 30
• Patients Per Site Per Month: 202.9

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Catheterization; Contamination	Procedure: single-gloving system; Procedure: double-gloving system	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Double Gloves: A Randomized Trial to Evaluate a Simple Strategy to Reduce Contamination During Resuscitation
• Study Start Date: Nov 1, 2014
• Anticipated Primary Completion Date: Dec 1, 2014
• Anticipated Study Completion Date: Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Catheterization Blood vessel Catheterization during resuscitation with single and double - gloving system. Catheterization was performed using simulation mannikin	Procedure: single-gloving system; single-gloving system was used during Catheterization; Procedure: double-gloving system; double-gloving system was used during Catheterization. inner and outer gloves were the same size

Outcome Measures

Primary Outcome Measures

1. visible puncture [1 day]

   Checking gloves for visible damage in the course of cannulation during resuscitation

Secondary Outcome Measures

1. WLT [1 day]

   Water leak test was used to checking unnoticed gloves damage

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	International Institute of Rescue Research and Education	Warsaw	Masovia	Poland	03-122

Sponsors and Collaborators

• International Institute of Rescue Research and Education

Investigators

• Principal Investigator: Lukasz Szarpak, Institute of Cardiology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Lukasz Szarpak, Lukasz Szarpak, Institute of Cardiology, Warsaw, Poland
• ClinicalTrials.gov Identifier: NCT02299752
• Other Study ID Numbers: Gloves/2014/01
• First Posted: Nov 24, 2014
• Last Update Posted: Nov 24, 2014
• Last Verified: Nov 1, 2014

Study Results

No Results Posted as of Nov 24, 2014