Preoperative Bath in Patients Submitted to Hip Arthroplasty

Surgical Wound Infection Clinical Trial

Official title:

Preoperative Bath in Patients Submitted to Hip Arthroplasty: Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03001102
• Other study ID #: EE-UFMG
• Status: Completed
• Phase: N/A
• Start date: August 2015
• Est. completion date: March 2018

Study information

• Verified date: February 2019
• Source: Federal University of Minas Gerais
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 162
• Est. completion date: March 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Surgical Wound
• Surgical Wound Infection
• Wound Infection

Intervention

Device:
• 4% Chlorhexidine gluconate
Cationic biguanide - antimicrobial action rubbing in the skin.
• 10% PVPI degermante
Polymer soluble in water of iodine with polyvinylpyrrolidone (PVP) - antimicrobial action rubbing in the skin.
• Soap without antiseptic
Liquid soap with glycerin, neutral pH. Skin cleansing

Locations

Country	Name	City	State
Brazil	Federal University of Minas Gerais	Belo Horizonte	Minas Gerais

Sponsors (2)

Lead Sponsor	Collaborator
Federal University of Minas Gerais	Fundação de Amparo à Pesquisa do estado de Minas Gerais

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Infection of Surgical Site (SSI)	The infections that develop after the surgical procedure	During the first 90 days after surgery
Secondary	Allergic reactions	Adverse reaction to a given product	In the first hours after procedure