NCT03001102

Preoperative Bath in Patients Submitted to Hip Arthroplasty

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 162 (actual)
• Sponsor: Federal University of Minas Gerais · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Accepted

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.

Conditions

• Surgical Wound Infection

Interventions

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

Timeline

• Start date: 2015-08-01
• Primary completion: 2018-01-01
• Completion: 2018-03-01
• First posted: 2016-12-22
• Last updated: 2019-02-28

Locations

1 site across 1 country: Brazil