Measures for the Prevention of Surgical Site Infection
- Conditions
- Infection
- Interventions
- Drug: CSAACDrug: CSAC
- Registration Number
- NCT03551561
- Lead Sponsor
- Universidade do Vale do Sapucai
- Brief Summary
Among the causes associated with infection of hospitalized patients, surgical site infection is a complication that is potentially associated with any type of surgical procedure, it also represents an expressive burden in terms of morbidity and mortality, as well as additional costs for health care systems around the world. It is regarded that the efficiency of the pre, per, and postoperative skin preparation depends on both the adopted antiseptic and the application method, with Chlorhexidine currently being the most used drug in such preparation. However, the manner, timing, or timing of cutaneous antisepsis action is unclear. Objective: Comparing antisepsis techniques using chlorhexidine-based soap associated with ethyl alcohol and alcoholic chlorhexidine versus chlorhexidine-based soap associated with alcoholic chlorhexidine, in surgical orthopedic procedures.
- Detailed Description
Among the causes associated with infection of hospitalized patients, surgical site infection is a complication that is potentially associated with any type of surgical procedure, it also represents an expressive burden in terms of morbidity and mortality, as well as additional costs for health care systems around the world. It is regarded that the efficiency of the pre, per, and postoperative skin preparation depends on both the adopted antiseptic and the application method, with Chlorhexidine currently being the most used drug in such preparation. However, the manner, timing, or timing of cutaneous antisepsis action is unclear. Objective: Comparing antisepsis techniques using chlorhexidine-based soap associated with ethyl alcohol and alcoholic chlorhexidine versus chlorhexidine-based soap associated with alcoholic chlorhexidine, in surgical orthopedic procedures. Methods: It is a primary, randomized, analytical and single-center clinical trial, consisting of 170 patients, which were distributed between 2 randomized groups, where Chlorhexidine-based Soap + Alcoholic Chlorhexidine were tested on the group CSAC and Chlorhexidine-based Soap + 70% Ethyl Alcohol + Alcoholic Chlorhexidine were tested on the group CSAAC. Cultures were performed in the Mannitol and EMB (Eosin Methylene Blue) media after being collected at the pre, post-skin preparation and end of the surgical procedure
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 170
- patients both males and females; older than 18 years old who will undergo orthopaedic surgical procedures;
- patients who do not follow the medical guidelines; that are non-collaborative and / or do not sign the terms of consent.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CSAAC group CSAC The CSAAC group (chlorhexidine-based soap + ethyl alcohol + alcoholic chlorhexidine): skin preparation process with 4% chlorhexidine-based soap for a period of 5 minutes, followed by a sterile and soaked with 70% alcohol compress. After removing the chlorhexidine-based soap excess, antisepsis was performed with alcoholic chlorhexidine and surgical drapes and gowns. Cultures were performed in the mannitol and EMB (Eosin Methylene Blue) media after being collected at the pre-skin preparation, post-skin preparation process and end of the surgical procedure. CSAC group CSAAC The CSAC group (chlorhexidine-based soap + alcoholic chlorhexidine): skin preparation process with 4% chlorhexidine-based soap for a period of 5 minutes and the of a simple, dry and sterile compress to remove the excess. After removing the excess, antisepsis was performed with alcoholic chlorhexidine and surgical drapes and gowns. Cultures were performed in the mannitol and EMB media after being collected at the pre-skin preparation, post-skin preparation process and end of the surgical procedure. CSAC group CSAC The CSAC group (chlorhexidine-based soap + alcoholic chlorhexidine): skin preparation process with 4% chlorhexidine-based soap for a period of 5 minutes and the of a simple, dry and sterile compress to remove the excess. After removing the excess, antisepsis was performed with alcoholic chlorhexidine and surgical drapes and gowns. Cultures were performed in the mannitol and EMB media after being collected at the pre-skin preparation, post-skin preparation process and end of the surgical procedure. CSAAC group CSAAC The CSAAC group (chlorhexidine-based soap + ethyl alcohol + alcoholic chlorhexidine): skin preparation process with 4% chlorhexidine-based soap for a period of 5 minutes, followed by a sterile and soaked with 70% alcohol compress. After removing the chlorhexidine-based soap excess, antisepsis was performed with alcoholic chlorhexidine and surgical drapes and gowns. Cultures were performed in the mannitol and EMB (Eosin Methylene Blue) media after being collected at the pre-skin preparation, post-skin preparation process and end of the surgical procedure.
- Primary Outcome Measures
Name Time Method Incidence of bacterial skin colonization about 6 hours Skin culture
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Universidade do Vale do Sapucai
🇧🇷Pouso Alegre, Minas Gerais, Brazil