NCT03001102

Brief Summary

Clinical trial for prevention, randomized, controlled, blinded, parallel, with three arms which purpose is verify the effects of nursing intervention preoperative bathing with 4% chlorhexidine gluconate, 10% Povidone iodine (PVPI) and soap without antiseptic, for the prevention of surgical site infection (SSI) in patients undergoing hip arthroplasty.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
162

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

December 20, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 22, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

February 28, 2019

Status Verified

February 1, 2019

Enrollment Period

2.4 years

First QC Date

December 20, 2016

Last Update Submit

February 26, 2019

Conditions

Surgical Wound Infection

Keywords

Preoperative CareBathsChlorhexidineSoapsPovidone-IodineArthroplasty, Replacement, HipSurgical Wound Infection

Outcome Measures

Primary Outcomes (1)

  • Infection of Surgical Site (SSI)

    The infections that develop after the surgical procedure

    During the first 90 days after surgery

Secondary Outcomes (1)

  • Allergic reactions

    In the first hours after procedure

Study Arms (3)

Bathing with 4% Chlorhexidine gluconate

SHAM COMPARATOR

Two baths with chlorhexidine using precise methods, including to scrubb the whole body with 50mL of undiluted solution, at night before surgery and the morning of surgery.

Device: 4% Chlorhexidine gluconate

Bathing with10% PVPI degermante

EXPERIMENTAL

Two baths with PVPI using precise methods, including to scrubb the whole body with 50mL of undiluted solution for each bath, at night before surgery and the morning of surgery.

Device: 10% PVPI degermante

Bathing with soap without antiseptic.

ACTIVE COMPARATOR

Two baths with soap using precise methods, including to scrubb the whole body with 50mL of undiluted solution for each bath, at night before surgery and the morning of surgery.

Device: Soap without antiseptic

Interventions

4% Chlorhexidine gluconateDEVICE

Cationic biguanide - antimicrobial action rubbing in the skin.

Also known as: HiBiScrub, 4% Chlorhexidine degermante
Bathing with 4% Chlorhexidine gluconate
10% PVPI degermanteDEVICE

Polymer soluble in water of iodine with polyvinylpyrrolidone (PVP) - antimicrobial action rubbing in the skin.

Also known as: Betadine, 10% Povidone iodine degermante
Bathing with10% PVPI degermante
Soap without antisepticDEVICE

Liquid soap with glycerin, neutral pH. Skin cleansing

Also known as: Non-medicated soap, Soap
Bathing with soap without antiseptic.

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Be 18 or older;
  • Elective procedure of total hip arthroplasty
  • No report of infectious focus at the surgical site
  • Know to respond to the clinical signs of a surgical infection or having a person responsible with this ability
  • Do not be a nasal carrier of Staphylococcus aureus before surgery
  • Have access to fixed or mobile phone

You may not qualify if:

  • Patient treating surgical site infection
  • Emergency hip prosthesis surgery or orthopedic trauma
  • Nasal carriers of Staphylococcus aureus before surgery
  • Previous history of allergic reactions to the products used in the bat

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Federal University of Minas Gerais

Belo Horizonte, Minas Gerais, Brazil

Location

MeSH Terms

Conditions

Surgical Wound Infection

Interventions

Abortion, Induced

Condition Hierarchy (Ancestors)

Wound InfectionInfectionsPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Obstetric Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Lúcia MC Franco, PhD student

    Federal University of Minas Gerais

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

December 20, 2016

First Posted

December 22, 2016

Study Start

August 1, 2015

Primary Completion

January 1, 2018

Study Completion

March 1, 2018

Last Updated

February 28, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

The study and the information provided will be confidential and used only for purposes of this research. Disclosure of information will be anonymous and in conjunction with the responses of a group of people, never individually.

Locations

BR(1)