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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 221
- Locations
- 1
- Primary Endpoint
- The number and type of latex allergic reactions occuring in our included patients up to 72 hours post-operatively.
Study Overview
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 Description
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 professionals have suggested the idea that planning these patients as first case of the day is no longer necessary because of certain technical evolutions in current operating room practice.(7) In a guideline published by the Australasian Society of Clinical Immunology and Allergy (last updated March 2010), patients at risk or with known latex allergy are no longer scheduled as first case of the day. However, this requires the removal of all powdered latex gloves from the OR (including pre-anesthesia unit, operating theatres, post anesthesia care unit and surroundings).(8) The requirement for a completely latex free environment en materials when operating on a actual patient with (suspected) latex allergy remains unchanged.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •All patients who report prior latex allergic reactions
- •High risk patients:
- •Frequent blather catheterization: meningomyelocoele, spina bifida, congenital defects of the uro-genital tract.
- •A medical history of multiple surgical procedures
- •Atopic constitution( asthma/hay fever/ eczema) and/ or a specific food allergy,eczema) and/ or a specific food allergy( avocado, kiwi, banana, hazelnut, stone fruit, chest nut and to a lesser extent grapes, mango, melon, pineapple, figs, cherry, passion fruit, walnut)(9)
- •professional exposure: health care workers, hairdressers, chemical industries
Exclusion Criteria
- •The patient refuses to cooperate. These patients will be treated in the same way, although we will not collect any data.
- •The patient patient is unable to cooperate as a result of circumstances that may interfere with collecting the data or make them unreliable. Eg. Language barriers.
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- 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(baseline)
- Prevalence of risk factors of latex allergy in the study population. assessment by questionnaire(baseline)
- Satisfaction regarding a new type of surgical gloves(assessment up to 8 months after introduction of the protocol)
- General satisfaction. Assessment by questionnaire(Assessment 8 months after introduction of the protocol)
- simplifacation of the OR schedule. Assesment by questionnaire(assessment up to 8 months after introduction of the protocol)