Measures for the Prevention of Surgical Site Infection

Infection Clinical Trial

— Orthopedics  

Official title:

Antisepsis Techniques in Orthopedic Surgical Procedures: a Comparative Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03551561
• Other study ID #: Surgical Site Infection
• Status: Completed
• Phase: N/A
• Start date: June 30, 2017
• Est. completion date: November 7, 2017

Study information

• Verified date: May 2018
• Source: Universidade do Vale do Sapucai
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 170
• Est. completion date: November 7, 2017
• Est. primary completion date: November 7, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients both males and females; older than 18 years old who will undergo orthopaedic surgical procedures;

Exclusion Criteria:

• patients who do not follow the medical guidelines; that are non-collaborative and / or do not sign the terms of consent.

Related Conditions & MeSH terms

• Communicable Diseases
• Infection

Intervention

Drug:
• CSAAC
Skin preparation 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.
• CSAC
Skin preparation 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.

Locations

Country	Name	City	State
Brazil	Universidade do Vale do Sapucai	Pouso Alegre	Minas Gerais

Sponsors (1)

Lead Sponsor	Collaborator
Universidade do Vale do Sapucai

Country where clinical trial is conducted

Brazil, 

References & Publications (30)

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* Note: There are 30 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of bacterial skin colonization	Skin culture	about 6 hours