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Safety of a Powder-free Latex Allergy Protocol in the Operating Theatre: A Prospective, Observational Cohort Study

NCT02575053 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 221

Last updated 2016-12-07

No results posted yet for this study

Summary

Study objectives

Primary objective:

This study wants to evaluate the safety of a latex safe protocol as proposed by the Australasian Society of Clinical Immunology and Allergy. In other words,the investigators hope to demonstrate that patients with known latex allergy or latex sensitisation can be treated safely in operating theatres without special requirements towards scheduling provided that all powdered latex gloves are removed from the OR environment( preparation rooms, theatres, recovery room and surroundings). In contrast, earlier guidelines require the theatre to be left unused during at least 3 hours before a patient with suspected latex allergy can be operated on in this theatre.

Secondary objectives:

* The investigators want to evaluate to what extend patients who report a latex allergy show risk factors of latex allergy.
* To investigate to what extend latex allergy was proven by laboratory testing or skin testing in patients who report a latex allergy.
* Type of latex allergic reaction when patients report a latex allergy.
* The level of satisfaction of surgeons and OR scheduling staff with the new latex safe protocol and with the switching to powder free latex gloves.

Conditions

  • Latex Hypersensitivity
  • Latex Allergy

Interventions

PROCEDURE

assessment of a new latex protocol

1. All powdered latex surgical gloves are removed from the operating theatres, recovery room and surroundings starting from 01-07-2015 in order to create a latex safe environment. Steps 2 and 3 remain unchanged in respect to ASA( American Society of Anesthesiologists) protocol. 2. Removal of all materials containing latex from the resuscitation carts. 3. Further requirements in case of latex allergic patients: * Identification of patients with (suspected) latex allergy. * All materials used during the procedure (catheters, drains, monitoring equipment,…) should be checked for latex. All latex containing materials should be removed from the room and latex free alternatives should be available. * All staff present in the room should use latex free synthetic gloves. * Operating tables and supports should be made of latex free material or should be covered with blankets. * The entire OR staff is thoroughly educated concerning the latex safe protocol.

Sponsors & Collaborators

  • Jessa Hospital

    lead OTHER

Principal Investigators

  • Jean-Paul Ory, MD · Attending, department of anesthesiology

  • Björn Stessel, MD · Attending, department of anesthesiology

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2016-10-31
Completion
2016-11-30

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02575053 on ClinicalTrials.gov