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

NCT02575053 | Completed

• 1 other identifier: 15.107/anesth15.02
• Study Type: observational
• Target: 221
• Locations: 1 country
• Sites: 1

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.

Conditions

Latex Hypersensitivity; Latex Allergy

Keywords

latex allergy; latex hypersensitivity; powder free latex surgical gloves; latex safe protocol

Outcome Measures

Primary Outcomes (1)

• The number and type of latex allergic reactions occuring in our included patients up to 72 hours post-operatively.

  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.

  72 hours after surgery

Secondary Outcomes (5)

• 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

• 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

• Satisfaction regarding a new type of surgical gloves

  assessment up to 8 months after introduction of the protocol

Study Arms (1)

Latex group

patients who report ( a high risk for) latex allergy and will be operated on

Procedure: assessment of a new latex protocol

Interventions

assessment of a new latex protocol PROCEDURE

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.

Latex group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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 (both inpatient and outpatient surgery)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jessa Hospital: lead

Study Sites (1)

Jessaziekenhuis Hasselt

Hasselt, Limburg, 3500, Belgium

Location

Related Publications (9)

• 1. American Society of Anesthesiologists Committee on Occupational Health of Operating Room Personnel. Natural Ruber Latex Allergy: Considerations for anesthesiologists. American Society of Anesthesiologists.[brochure] 2005: 1-30.

  BACKGROUND

• 2. Association of Surgical Technologists. Guideline statements for the N atural Rubber Latex Protein allergic patient in the operating room environment(adopted BOD October 2005, updated BOD January 2014). [available from: www.ast.org] accessed 19/08/2015.

  BACKGROUND

• Demaegd J, Soetens F, Herregods L. Latex allergy: a challenge for anaesthetists. Acta Anaesthesiol Belg. 2006;57(2):127-35.

  PMID: 16916182 BACKGROUND

• Reines HD, Seifert PC. Patient safety: latex allergy. Surg Clin North Am. 2005 Dec;85(6):1329-40, xiv. doi: 10.1016/j.suc.2005.09.014.

  PMID: 16326213 BACKGROUND

• Becker HS. An analysis of the epidemiology of latex allergy: implications for primary prevention. Medsurg Nurs. 2000 Jun;9(3):135-43.

  PMID: 11033703 BACKGROUND

• 6. American Association of Nurse Anesthetists. Latex allergy management( Guidelines). [available from: www.aana.org] accessed 15/08/2015.

  BACKGROUND

• Sleth JC. [Starting the day with latex-sensitised patients: still up to date?]. Ann Fr Anesth Reanim. 2011 Oct;30(10):764-5. doi: 10.1016/j.annfar.2011.06.006. Epub 2011 Jul 20. No abstract available. French.

  PMID: 21764543 BACKGROUND

• 8. Australasian Society of Clinical Immunology and Allergy. Operating suite guidelines for latex allergic patients. [Available online from: www.allergy.org] accessed 15/08/2015.

  BACKGROUND

• Binkley HM, Schroyer T, Catalfano J. Latex allergies: a review of recognition, evaluation, management, prevention, education, and alternative product use. J Athl Train. 2003 Apr;38(2):133-40.

  PMID: 16558678 BACKGROUND

Related Links

• Website of the Association of Surgical Technicians: Guideline statements for the Natural Rubber Latex Protein allergic patient in the operating room environment(adopted BOD October 2005, updated BOD January 2014).
• Website of the American Association of Nurse Anesthetists: Latex allergy management( Guidelines)

MeSH Terms

Conditions

Latex Hypersensitivity

Condition Hierarchy (Ancestors)

Hypersensitivity; Immune System Diseases

Study Officials

• Jean-Paul Ory, MD

  Attending, department of anesthesiology

  PRINCIPAL INVESTIGATOR

• Björn Stessel, MD

  Attending, department of anesthesiology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2015
• First Posted: October 14, 2015
• Study Start: October 1, 2015
• Primary Completion: October 1, 2016
• Study Completion: November 1, 2016
• Last Updated: December 7, 2016

Record last verified: 2016-11

Locations

BE (1)