Measures for the Prevention of Surgical Site Infection

NCT03551561 | Completed DMC

• 1 other identifier: Surgical Site Infection
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

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.

Conditions

Infection

Keywords

Chlorhexidine; Infection; Orthopedics; Surgical rooms; Antisepsis; Surgical Procedures.

Outcome Measures

Primary Outcomes (1)

• Incidence of bacterial skin colonization

  Skin culture

  about 6 hours

Study Arms (2)

CSAAC group

ACTIVE COMPARATOR

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.

Drug: CSAAC; Drug: CSAC

CSAC group

ACTIVE COMPARATOR

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.

Drug: CSAAC; Drug: CSAC

Interventions

CSAAC DRUG

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.

Also known as: chlorhexidine-based sopa+70% alcool+alcoholic chlorhexidine

CSAAC group; CSAC group

CSAC DRUG

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.

Also known as: chlorhexidine-based sopa + alcoholic chlorhexidine

CSAAC group; CSAC group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Universidade do Vale do Sapucai: lead

Study Sites (1)

Universidade do Vale do Sapucai

Pouso Alegre, Minas Gerais, 37.550-000, Brazil

Location

Related Publications (30)

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MeSH Terms

Conditions

Infections

Study Officials

• Eugenio C Mendes, MD

  Universidade do Vale do Sapucai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2018
• First Posted: June 11, 2018
• Study Start: June 30, 2017
• Primary Completion: November 7, 2017
• Study Completion: November 7, 2017
• Last Updated: June 11, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)