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The Use of 2% Chlorhexidine Gluconate Impregnated Cloth Bathing in Preoperative Skin Preparation

20. januar 2019 oppdatert av: Fernanda de Oliveira Andrade, University of Sao Paulo

Surgical Site Infection and the Use of 2% Chlorhexidine Gluconate Impregnated Cloth Bathing in Preoperative Skin Preparation: a Pilot Randomized Clinical Trial.

To compare the use of towels impregnated with 2% chlorhexidine gluconate in the traditional preoperative bath with 2% chlorhexidine gluconate in preventing the occurrence of surgical site infection among patients undergoing potentially contaminated elective surgery.

Studieoversikt

Detaljert beskrivelse

This is a pilot randomized controlled clinical trial, composed of patients submitted to potentially contaminated elective surgeries, randomly assigned to an intervention group, consisting of those who used towels impregnated with pre-operative CHG 2% and control group, composed of by the pre-operative bath with 2% conventional / liquid CHG. Both used the products the night before and the morning of surgery and received verbal and written guidance.

Studietype

Intervensjonell

Registrering (Faktiske)

1

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • Parana
      • Curitiba, Parana, Brasil
        • Fernanda de Oliveira Andrade

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • 18 years of age or over
  • literate
  • undergoing potentially contaminated elective surgeries
  • admitted on the day before the surgical treatment or in the triple three-day hospital stay prior to surgery, without an infectious or otherwise infected process
  • correctly follow the instructions for the use of towels impregnated with chlorhexidine gluconate 2%
  • follow the instructions for the use of chlorhexidine gluconate 2%

Exclusion Criteria:

  • submitted to previous surgeries, in a period of less than thirty days, or ninety days in the case of a prosthesis implant
  • present skin lesions or known allergy to chlorhexidine gluconate 2%
  • patients submitted to videolaparoscopic surgeries and vaginal surgeries
  • patients who had daily use of products containing antiseptics (creams and / or liquid or bar soaps containing CHG, triclosan or similar) in their daily activity; or who had used antibiotics or similar drugs two weeks before and during the period of data collection.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: towels with chlorhexidine gluconate 2%
Composed of 25 patients, who received 2 towels with chlorhexidine gluconate 2% packages each containing six towels and detailed instructions on the form and sequence of application of the towels; the time of application, that is, the night before surgery, between 20 and 22h, and, on the morning of surgery, between 5 and 6h; besides other general orientations.

The first TICHG should be used on the neck, chest and abdomen; The second TICHG should be used on the right upper limb, start at the shoulder; The third TICHG was intended for the upper left limb; The fourth TICHG should be used on the neck and chest; The fifth TICHG was for the right lower limb; The sixth TICHG should be used on the lower left limb.

2) Time of application: use six TICHGs the night before surgery and the six remaining on the morning of surgery.

3) After the hygiene of each member, discard the TICHG. After use of TICHG, allow the product to dry on the skin. Do not use bath towels to dry yourself and wear clean clothes.

Aktiv komparator: chlorhexidine gluconate 2% liquid
Composed of 23 patients, two 100 ml flasks of chlorhexidine gluconate 2% liquid were supplied, and detailed instruction manual for the product, containing form and application sequence; time of application (the night before surgery, between 20 and 22h, and on the morning of surgery, between 5 and 6h); and general guidelines.
Spread the product on the skin during the bath and massage for 3 minutes, so that it is distributed equally to all parts of the body (except the face, hair and intimate area). Then rinse with water and dry with a clean, dry towel, and wear clean clothes.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Prevention of surgical site infection - Criteria: Centers for Disease Control and Prevention, 2018
Tidsramme: 1 month (30 days)

In order to investigate the potential cases of SSI, the researcher personally followed the patients in the preoperative period, in the POI and at the time of hospital discharge, using a data collection instrument. In order to evaluate the occurrence of SSI after hospital discharge, the researcher used the following strategies: a review of the chart associated with patient follow-up during outpatient return when possible, which would occur on average on the 35th postoperative day; telephone contact from the 30th day until the 40th postoperative day (PO), using a post-discharge surveillance instrument. Continuous and discrete quantitative variables were evaluated using the Wilcoxon-Mann-Whitney test.

Qualitative (categorical) variables were evaluated using the Pearson X² test. The Wilcoxon-Mann-Whitney test was used for qualitative (categorical) variables, whose distribution was different from normal.

1 month (30 days)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Hovedetterforsker: Fernanda Andrade, University of Sao Paulo
  • Hovedetterforsker: Vanessa Poveda, University of Sao Paulo

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

2. mai 2017

Primær fullføring (Faktiske)

28. august 2018

Studiet fullført (Faktiske)

28. september 2018

Datoer for studieregistrering

Først innsendt

9. januar 2019

Først innsendt som oppfylte QC-kriteriene

20. januar 2019

Først lagt ut (Faktiske)

23. januar 2019

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

23. januar 2019

Siste oppdatering sendt inn som oppfylte QC-kriteriene

20. januar 2019

Sist bekreftet

1. januar 2019

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

Nei

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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