- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00738543
Povidone-iodine Against Sodium Hypochlorite as Skin Antiseptics
18. juni 2013 opdateret af: Alejandro E. Macias, Universidad de Guanajuato
Comparative Study of 10% Povidone-iodine Against 10% Sodium Hypochlorite as Skin Antiseptics in Human Volunteers.
The investigators have few options for skin antisepsis.
Alternatives for povidone-iodine, which is the most commonly used agent, are costly or ineffective.
To have more options, this study is needed.
The investigators want to know if there are difference between the use of 10% sodium hypochlorite or 10% povidone-iodine for skin antisepsis.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Sodium hypochlorite at 10% has been widely used as antiseptic in patients on dialysis as well as for irrigation of wounds and burns.
Since it has been used successfully in caring for the exit site of hemodialysis catheters, it is reasonable to propose its use for the insertion and care of central intravascular catheters, as well as for skin preparation before surgery.
Alternatives for povidone-iodine, which is the agent most commonly used, are costly or ineffective.
To have more options, this study is needed to know if 10% sodium hypochlorite is similar to the most common option for skin antisepsis.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
48
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Guanajuato
-
Leon, Guanajuato, Mexico, 37000
- University of Guanajuato School of Medicine
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Healthy adult volunteers.
Exclusion Criteria:
- History of skin allergies or atopy, as well as reactions to soaps, iodine, chlorine, or latex
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Whole group of 48 volunteers
The arm is composed of 48 human volunteers to test 10% povidone-iodine (Isodine Solucion ®, Boehringer-Ingelheim Promeco, Mexico City), Hypochlorite 10% of electrochemical production (Exsept 10% ®, Pisa, Guadalajara, Mexico), and control.
|
Two antiseptics (10% povidone iodine and 10% sodium hypochlorite) and one control were tested as skin antiseptics.
The intervention consisted of preparing the skin with the antiseptic or the control.
The areas were approximately 25 cm2 on the forearm for each antiseptic or control.
The antiseptic or control were applied in an outward circular motion using a swab that was soaked with the solution.
The solution was then kept on the skin for 60 seconds before the bacterial culture was conducted.
All volunteers were instructed to continue the use of neutral soap and shampoo without antiseptics during the follow-up period.
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Bacterial Count of Skin Cultures for the 10% Povidone-iodine Period
Tidsramme: 24 hours
|
Bacterial colony count of skin cultures to determine antiseptic properties
|
24 hours
|
Bacterial Colony Forming Units for the 10% Sodium Hypochlorite Period
Tidsramme: 24 hours
|
After incubation, the outcome assessor counted the colonies to determine the colony-forming units per square centimeter (CFU/cm2) of skin.
|
24 hours
|
Bacterial Colony Forming Units for the Control Period
Tidsramme: 24 hours
|
After incubation, the outcome assessor counted the colonies to determine the colony-forming units per square centimeter (CFU/cm2) of skin.
|
24 hours
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Presence of Skin Reactions for the 10% Povidone-iodine Period
Tidsramme: 24 hours
|
Presence of allergy or any skin reaction at 24 hours after the antiseptic application
|
24 hours
|
Presence af Allergy or Skin Reaction for the 10% Sodium Hypochlorite Period
Tidsramme: 24 hours
|
Presence of allergy or skin reaction at 24 hours after the application of the antiseptic
|
24 hours
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Alejandro E Macias, M. D., Universidad de Guanajuato
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. august 2008
Primær færdiggørelse (Faktiske)
1. december 2008
Studieafslutning (Faktiske)
1. december 2008
Datoer for studieregistrering
Først indsendt
18. august 2008
Først indsendt, der opfyldte QC-kriterier
19. august 2008
Først opslået (Skøn)
20. august 2008
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
24. juni 2013
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
18. juni 2013
Sidst verificeret
1. februar 2009
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- FMUGAmuch
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med WHOLE GROUP OF 48 VOLUNTEERS
-
The University of Texas Health Science Center,...Texas Neurological Society Research Grant-2020Afsluttet
-
Dr. Asim AlamTrukket tilbageTrauma | Hypotermi | Temperaturændring, kropCanada
-
Indiana UniversityNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Afsluttet
-
Southwest Regional Wound Care CenterNext Science TMAfsluttetSårinfektionForenede Stater
-
University of Maryland, BaltimoreAktiv, ikke rekrutterendeDiabetes mellitusForenede Stater
-
Eurofarma Laboratorios S.A.Ikke rekrutterer endnu
-
Florida State UniversityUniversity of North Carolina, Chapel Hill; University of GeorgiaTilmelding efter invitationKardiovaskulær sygdom risikoreduktionForenede Stater
-
Centre Hospitalier Universitaire Saint PierreRekrutteringKæbekirurgi | Hoved- og halskirurgiBelgien
-
Memorial Sloan Kettering Cancer CenterAktiv, ikke rekrutterende