Preoperative Bath in Patients Submitted to Hip Arthroplasty

Federal University of Minas Gerais

Status: Completed

Conditions: Surgical Wound Infection

Treatments: Device: 10% PVPI degermante; Device: 4% Chlorhexidine gluconate; Device: Soap without antiseptic

Study type: Interventional

Funder types: Other

Identifiers

NCT03001102

EE-UFMG

Details and patient eligibility

About

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.

Full 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.

Enrollment: 162 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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162 participants in 3 patient groups

Bathing with 4% Chlorhexidine gluconate

Sham Comparator group

Description:

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.

Treatment:

Device: 4% Chlorhexidine gluconate

Bathing with10% PVPI degermante

Experimental group

Description:

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.

Treatment:

Device: 10% PVPI degermante

Bathing with soap without antiseptic.

Active Comparator group

Description:

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.

Treatment:

Device: Soap without antiseptic