Surgical Wound Infection
Conditions
Keywords
Preoperative Care, Baths, Chlorhexidine, Soaps, Povidone-Iodine, Arthroplasty, Replacement, Hip, Surgical Wound Infection
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.
Interventions
Cationic biguanide - antimicrobial action rubbing in the skin.
DEVICE10% PVPI degermante
Polymer soluble in water of iodine with polyvinylpyrrolidone (PVP) - antimicrobial action rubbing in the skin.
DEVICESoap without antiseptic
Liquid soap with glycerin, neutral pH. Skin cleansing
Sponsors
Fundação de Amparo à Pesquisa do estado de Minas Gerais
Federal University of Minas Gerais
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Infection of Surgical Site (SSI) | During the first 90 days after surgery | The infections that develop after the surgical procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Allergic reactions | In the first hours after procedure | Adverse reaction to a given product |
Countries
Brazil
Outcome results
None listed