Latex Allergy Clinical Trial
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
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.
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.
Although several studies have shown the importance of powdered gloves in the spread of
airborne latex particles and the basis for this protocol seams acceptable and logical, there
is currently no literature confirming the safety of this practice in a clinical setting.
Study objective
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.
Study procedure
Pre-operative setting:
Medical history, including allergies of every patient will be assessed . Every patient with
(suspected) latex allergy who will undergo surgery will be approached to participate in this
study. There are no restrictions regarding type of surgery.
The research team will ask all eligible patients to sign an informed consent. The
researchers will ask all patients who are willing to participate to complete a short
questionnaire.
Patients refusing to participate will be treated by the same protocol. However, they will
not be contacted in order to provide further medical data in relation to this study.
During the stay in the OR:
Nursing staff and the anesthesiologist perform a time-out procedure prior to surgery. A
(suspected) latex allergy is marked in the electronic case file. The software registers this
cases and sends a confirmation to the research team.
At the end of the procedure, the anesthesiologist marks if a latex allergic reaction has
occurred through a pop -up in the electronic case file.
Post-operative setting:
• Recovery room: Continuation of the latex safe protocol. When the patient is discharged to
the ward, a pop-up in the electronic case file asks if any type of latex allergic reaction
has occurred.
The patient receives a short note, explaining that the research team will contact him/her
after 72 hours.
• Wards/ discharge from hospital: The research team will contact every patient who was
marked latex allergic 72 hours after their surgery to answer the questionnaire about any
allergic reaction to latex( by phone or in person).
Types of latex reactions:
1. Irritation dermatitis: a non-allergic reaction of the skin to an irritans. Lesions are
limited to the area of contact and may occur minutes to hours after exposure. Symptoms
include itching, erythema, a burning sensation, blistering, flakiness and fissuring of
the skin. This type of reaction is never life-threatening.(1,3,6)
2. Allergic contact dermatitis or delayed cell- mediated hypersensitivity reaction or type
4 reaction: T- cell mediated sensitivity for chemical additives absorbed by the skin.
Lesions occur after 6 to 48 hours following exposure and peak after 48 to 72 hours. The
lesions may exceed the contact area and consist of itching, erythema, blistering or
flakiness.( Symptoms often resemble those of irritation dermatitis.)(1,3,6)
3. IgE mediated immediate hypersensitivity( type 1 reaction:
Based on B-cell mediated production of IgE (immunoglobulin E) antibodies towards Hev b latex
proteins after a first exposure. Symptoms already occur after a few minutes up to 1 hour,
depending of the route of exposure (inhalation, parenteral or mucous membrane exposure). The
severity of the reaction also varies in relation to the route of exposure. Type 1 allergic
reactions in response to latex exposure may be lethal.(1,2,3)
Note:
• If the research team( or in daily practice: the attending physician) suspects a latex
allergic reaction during the study period , they will determine RIA(radioimmunoassay) -
tryptase in case of an anaphylactic reaction. Furthermore, the patient will be referred to
an allergy consultant for skin prick test in order to confirm a possible latex allergy.
Satisfaction about the newly implemented protocol:
Starting from 01-02-2016, the research team will investigate the level of satisfaction about
the newly implemented protocol by means of a short questionnaire( written or E-mail) sent to
all involved surgeons and OR scheduling staff.
With this questionnaire, the investigators want to evaluate
- general satisfaction regarding the new protocol by means of a numeric rating scale
ranging from 0 (very unsatisfied) up to 10 (very satisfied).
- 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).
- the level of satisfaction regarding the new type of surgical gloves in case the surgeon
had to switch.The investigators will do so by means of a numeric rating scale ranging
from 0 (very unsatisfied) up to 10 (very satisfied).
;
Observational Model: Cohort, Time Perspective: Prospective
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT05515276 -
The COVID-19 Pandemic Process Increase Latex Glove Use and Latex Allergy Complaints in Hospital Nurses? Survey Study
|
||
| Terminated |
NCT01133288 -
Yulex Glove Prospective Study in Spina Bifida
|
N/A |