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NCT04347057
The Effect of Chlorhexidine Bathing on MRSA and VRE Colonization Among Haematology-Oncology ICU Patients
NA trial testing Bed bathing with 2% CHG solution in MRSA Colonization in 78 participants. Completed in 1 August 2019.
19 July 2019
Quick facts
| Lead sponsor | Hacettepe University |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 78 |
| Start date | 1 June 2018 |
| Primary completion | 19 July 2019 |
| Estimated completion | 1 August 2019 |
| Sites | 1 location across Turkey (Türkiye) |
Drugs / interventions tested
- Bed bathing with 2% CHG solution
- Bed bathing with soap and water
Conditions studied
- MRSA Colonization — all drugs for MRSA Colonization →
- VRE Colonization — all drugs for VRE Colonization →
Sponsor
Hacettepe University
Who can join
18 and older, any sex, with MRSA Colonization or VRE Colonization. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04347057 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Hacettepe University
- Last refreshed: 15 April 2020
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