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

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Switching to Powder Free Latex Gloves in the Entire OR as Part of a New ' Latex Safe' Protocol: a Safe Alternative? A Prospective, Observational Cohort Study

Brief 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.

Detailed Summary:

Introduction

Allergic reactions to natural rubber latex( NRL, or Latex) are an important issue in daily anesthesia practice. Latex allergy may result in lesions consistent with irritation dermatitis and type 4 allergic contact dermatitis. But it may also result in type 1 allergic reactions which are potentially lethal.(1) The prevalence of latex allergy in a general population is estimated less than 1%, but sensitization can rise up to 5.4-7.6%.(3,4) In certain populations at risk, the prevalence of latex allergy and sensitization rises up to 17% in health care workers an even 73% in patients who were exposed to latex on a regular basis( eg. Patients with spina bifida).

These patients require special logistic and organizational requirements during their stay in the operating room. Nowadays, both guidelines from the Belgian Society of Anesthesiology and Resuscitation(BVAR-SARB) as the American Association of Anesthesiologists recommend these patients to be scheduled as the first case of the day.(1,3) In this way, these patients are treated in an environment with a minimal amount of airborne latex particles. After all, studies have proven that using powdered latex gloves causes a substantial contamination of the operating room. Latex particles can even remain airborne up to 5 hours afterwards.(1,3,5).

In consequence, the guidelines mentioned earlier dictate patients with a (high risk for) latex allergy to be treated in an operating theatre left unused during at least 3 to 6 hours.(1,2,6) Of course, such requirements can result in organizational problems potentially resulting in delaying procedures, financial losses, patient discomfort and dissatisfaction with both patients as well as hospital staff.

The last years, some profes
Sponsor: Jessa Hospital

Current Primary Outcome: The number and type of latex allergic reactions occuring in our included patients up to 72 hours post-operatively. [ Time Frame: 72 hours after surgery ]

The research team wants to investigate how many latex allergic reactions occur. types:

  1. Irritation dermatitis: non-allergic reaction to an irritans,minutes to hours after exposure. Symptoms:

    itching, erythema, a burning sensation, blistering, flakiness and fissuring of the skin. Never life-threatening.

  2. Allergic contact dermatitis( type 4 reaction): T- cell mediated sensitivity for chemical additives absorbed by the skin. Occurs 6 to 48 hours following exposure and peaks after 48 to 72 hours. Lesions may exceed the contact area and consist of itching, erythema, blistering or flakiness.( cf irritation dermatitis.)
  3. IgE mediated immediate hypersensitivity( type 1 reaction):

B-cell mediated production of IgE antibodies towards Hev b latex proteins. Symptoms: after a few minutes up to 1 hour, depending of the route of exposure( inhalation, parenteral,mucous membrane exposure). Severity also varies in relation to the route of exposure. Potentially lethal anaphylaxis.



Original Primary Outcome: Same as current

Current Secondary Outcome:

  • How many patients (percentage of patients) who report a latex allergy have confirmed this diagnosis by laboratory testing or skin prick tests? Assessment by questionnaire [ Time Frame: baseline ]
  • Prevalence of risk factors of latex allergy in the study population. assessment by questionnaire [ Time Frame: baseline ]

    To what extend do patients who report a latex allergy show risk factors such as:

    Congenital defects of the genito-urinary tract

    Spina bifida

    Meningomyelocoele

    a medical history consisting of multiple surgical procedures

    Food allergies (tropical fruit, nuts, stone fruit, avocado, others)

    Atopic constitution( asthma, eczema, rhinitis, hay fever)

    Professional exposure( hairdressers, health care workers, latex exposure in latex industries or chemical related jobs)

    (anaphylaxis of unknown origin during previous hospital stays or procedures)

  • General satisfaction. Assessment by questionnaire [ Time Frame: Assessment 8 months after introduction of the protocol ]

    This study wants to evaluate the level of satisfaction with surgeons and OR scheduling staff regarding the newly implemented protocol.The investigators will do so by scoring satisfaction on numeric rating scales(NRS).The research team will evaluate:

    General satisfaction by means of a numeric rating scale ranging from 0(very dissatisfied) to 10 ( very satisfied).

    The new protocol was implemented starting from 01-07-2015. The investigators will evaluate general satisfaction 8 months after implementation( period of 01-02-2016 till 01-03-2016).

  • simplifacation of the OR schedule. Assesment by questionnaire [ Time Frame: assessment up to 8 months after introduction of the protocol ]

    The research team will evaluate whether this new protocol has simplified the OR schedule. The investigators will do so by means of a numeric rating scale ranging from 0(not true at all) up to 10(absolutely true) which has to be answered by surgeons and OR scheduling staff.

    The investigators will evaluate this up to 8 months after introduction of the new protocol(period of 01-02-2016 till 01-03-2016).The new protocol was implemented starting from 01-07-2015.

  • Satisfaction regarding a new type of surgical gloves [ Time Frame: assessment up to 8 months after introduction of the protocol ]
    The investigators will evaluate the level of satisfaction regarding the new type of surgical gloves in case the surgeon had to switch. We will do so by means of a numeric rating scale ranging from 0 (very unsatisfied) up to 10 (very satisfied). The investigators will evaluate this up to 8 months after introduction of the new protocol( period of 01-02-2016 till 01-03-2016).The new protocol was implemented starting from 01-07-2015.


Original Secondary Outcome: Same as current

Information By: Jessa Hospital

Dates:
Date Received: October 6, 2015
Date Started: October 2015
Date Completion:
Last Updated: December 6, 2016
Last Verified: November 2016