Preoperative Bath in Patients Submitted to Hip Arthroplasty | NCT03001102

Studies
Preoperative Bath in Patients Submitted to Hip Arthroplasty

NCT03001102

Sponsor

Federal University of Minas Gerais

Status

Completed

Last Update Posted

Feb 28, 2019Actual

Enrollment

162Actual

Phase

Not Applicable

Conditions

Surgical Wound Infection

Interventions

4% Chlorhexidine gluconate
10% PVPI degermante
Soap without antiseptic

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2015Actual

Primary Completion Date

Jan 2018Actual

Completion Date

Mar 2018Actual

First Submitted Date

Dec 20, 2016

First Submission Date that Met QC Criteria

Dec 21, 2016

First Posted Date

Dec 22, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 26, 2019

Last Update Posted Date

Feb 28, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Lucia Maciel de Castro Franco, PhD, Federal University of Minas GeraisPrincipal Investigator

Lead Sponsor

Federal University of Minas GeraisOTHER

Collaborators

Name	Class
Fundação de Amparo à Pesquisa do estado de Minas Gerais	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Despite the recommendation in several guidelines of preoperative bathing with 4% chlorhexidine gluconate as a measure for the prevention of SSI, there is no evidence in the literature that support this practice. The objective of this study is to evaluate the effect of nursing intervention: preoperative bath using 4% chlorhexidine gluconate solutions, 10% povidone iodine degermante or soap without antiseptic for the prevention of SSI in patients undergoing elective hip arthroplasty surgery. The specific objectives are to compare the incidence of SSI in the three interventions, to assess the most effective intervention for the prevention of surgical infection and to estimate the frequency of allergic reactions caused by the use of the solutions. Two intervention groups (4% Chlorhexidine gluconate and PVPI10%) and a control group (without antiseptic soap) composed of 52 patients undergoing hip arthroplasty in each group will be randomized to perform the baths in the period from may 2015 to june 2017. Before the intervention, nasal swabs will be collected of patients to investigate colonization by Staphylococcus aureus.

The expected result is lower ISC rate with the proposed measures.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

162Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
4% Chlorhexidine gluconate	Device	Cationic biguanide - antimicrobial action rubbing in the skin.	Bathing with 4% Chlorhexidine gluconate

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Infection of Surgical Site (SSI)	The infections that develop after the surgical procedure	During the first 90 days after surgery

Secondary Outcomes

Measure	Description	Time Frame
Allergic reactions	Adverse reaction to a given product	In the first hours after procedure

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Lúcia MC Franco, PhD student	Federal University of Minas Gerais	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Federal University of Minas Gerais		Belo Horizonte	Minas Gerais		Brazil

IPD Sharing Statement Module

Plan to Share IPD

Description

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.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D013530	Surgical Wound Infection

Ancestor Terms

ID	Term
D014946	Wound Infection
D007239	Infections
D011183	Postoperative Complications
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000028	Abortion, Induced

Ancestor Terms

ID	Term
D013513	Obstetric Surgical Procedures
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided