The Effect of Chlorhexidine Bathing on MRSA and VRE Colonization Among Haematology-Oncology ICU Patients

NCT04347057 | Completed DMC

• 1 other identifier: S217134
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

Hospital-acquired infections (HIs) are defined as an infection developed within 48-72 hours of admission to hospital in whom the infection was not incubating at the time of admission to the hospital or an infection acquired in the hospital but appearing 10 days after discharged. Hospital infections threaten patient safety due to the complications they cause, even if they are preventable problems. Staphylococcus aureus and enterococci which cause hospital infections are among the important pathogens in terms of antibiotic resistance development (MRSA: Methicillin-resistant Staphylococcus aureus, VRE: Vancomycin-resistant Enterococcus). Patients undergoing treatment in ICU are at a higher risk of infection than patients in other units of the hospital because of the seriousness of their condition and their high exposure to invasive procedures. MRSA and VRE are two important microorganism types that cause infection in patients who are hospitalized in ICU and take long-term care. In general, international recommendations for prevention and control of hospital infections include handwashing and individual hygiene practices with skin antisepsis. Chlorhexidine gluconate is a broad-spectrum antimicrobial and bacteria killing agent that causes less irritation to skin. In the literature, bathing with various concentrations of chlorhexidine has been shown to significantly reduce the MRSA and VRE contamination risk and skin colonization. These studies are mostly performed in medical, surgical or cardiology ICU but there are very limited studies in the hematology-oncology patients who are more susceptible for the hospital infections because of the their illnesses and treatments. According to the crossover design; patients who meet the sampling inclusion criteria within the first 24 hours of the ICU admission will be randomly separated two arm (n = 30 for each arm) and bath applications will be performed. After the first swab sample will be taken; the control and intervention bathing protocols will be applied to each group of patients. To evaluate the effectiveness of the bath product another swab sample will be taken after 4-6 hours after the bathing. It is thought that to study on this subject is very important because of the bath bathing which is a personal hygiene practices is a basic nursing application and there is a limited literature information about the effectiveness of these bathing on to prevent the infections in our country and a limited world and national literature information with cancer patients. The results obtained from the research will be contributing the literature and searching area of the prevention and control of hospital infections and will be provide the guidance on the development of patient care quality

Conditions

MRSA Colonization; VRE Colonization

Outcome Measures

Primary Outcomes (1)

• MRSA and/or VRE skin colonization rates

  Wiping baths with 2% CHG solution would have lower MRSA and/or VRE skin colonization rates with statistically significant differences compared to the soap and water baths

  8 days for all participants

Study Arms (2)

Arm 1

EXPERIMENTAL

Arm 1 (39 patients) included first the control period, followed by one-day wash-out, and then the intervention period. Procedures for control period included providing daily bed bathing with soap and water over three consecutive days, while intervention period included daily bed bathing with 2% CHG solution over three consecutive days.

Other: Bed bathing with 2% CHG solution; Other: Bed bathing with soap and water

Arm 2

EXPERIMENTAL

Arm 2 (39 patients) included first the intervention period, followed by one-day wash-out, and then the control period. Procedures for control period included providing daily bed bathing with soap and water over three consecutive days, while intervention period included daily bed bathing with 2% CHG solution over three consecutive days.

Other: Bed bathing with 2% CHG solution; Other: Bed bathing with soap and water

Interventions

Bed bathing with 2% CHG solution OTHER

Patients were bathed from the neck down, avoiding contact with face, mucous membranes and wounds by wiping with CHG solution for each period. The patient's skin bathed in the order of clean area to dirty area. Additionally, if patients in both arms became soiled after the daily baths, contaminated body areas were wiped using water and disposable washcloths. Patients were assessed daily for localised or body-wide skin reactions.

Arm 1; Arm 2

Bed bathing with soap and water OTHER

Patients were bathed from the neck down, avoiding contact with face, mucous membranes and wounds by wiping with soap and water. The patient's skin bathed in the order of clean area to dirty area. Additionally, if patients in both arms became soiled after the daily baths, contaminated body areas were wiped using water and disposable washcloths. Patients were assessed daily for localised or body-wide skin reactions. During control period, patients were washed with soap and then rinsed with water, and dried with disposable towels

Arm 1; Arm 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged over 18 years Diagnosed with a hematologic-oncologic disease Admitted within the first 24 hours to the ICU

You may not qualify if:

• Age \< 18 years Burns to \>20% of the total skin surface Pregnancy Previous MRSA and/or VRE infection history or antibiotic use for these infections Receiving radiation therapy Admitted before 24 hours to ICU Re-admission to ICU Diagnosed with severe septic shock, massive pulmonary thromboembolism, massive haemoptysis, and status epilepticus General condition disorder

Sponsors & Collaborators

• Hacettepe University: lead
• The Scientific and Technological Research Council of Turkey: collaborator

Study Sites (1)

Hacettepe University

Ankara, Altindag, 06100, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Soaps; Water

Intervention Hierarchy (Ancestors)

Detergents; Surface-Active Agents; Specialty Uses of Chemicals; Chemical Actions and Uses; Household Products; Technology, Industry, and Agriculture; Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Fundamentals of Nursing, Faculty of Nursing

Model Details: Arm 1 (39 patients) included first the control period, followed by one-day wash-out, and then the intervention period. Arm 2 (39 patients) included first the intervention period, followed by one-day wash-out, and then the control period. The first patient was assigned to the second arm after the draw, and the patients continued to take the first arm and second arm respectively. Each period lasted three consecutive days with a total of 7 days for each patient. During the period of the study, 8 patients from Arm1 and 9 patients from Arm 2 could not complete the study due to several reasons. Thus, the final sample consisted of 31 patients in Arm 1 and 30 patients in Arm 2.

Study Record Dates

• First Submitted: April 13, 2020
• First Posted: April 15, 2020
• Study Start: June 1, 2018
• Primary Completion: July 19, 2019
• Study Completion: August 1, 2019
• Last Updated: April 15, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR

Locations

TU (1)