Impact of Postoperative Skin Disinfection With Chlorhexidine on Bacterial Colonization

Phase 4

Completed

• Conditions: Surgical Site Infection
• Interventions: Drug: Sodium Chloride

• Registration Number: NCT06114459
• Lead Sponsor: Linkoeping University

Brief Summary

A double-blinded, controlled study was conducted at one county hospital in Sweden. Patients were randomly assigned, skin samples were collected at four times; baseline, preoperative, after intervention and after 48 hours. Bacterial colonization were assessed.

Detailed Description

METHOD Study design

This was a double blinded, controlled, block-randomized intervention study with random allocation to Chlorhexidine- group or Sodium Chloride- group.
...

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2019-08-10
• Primary Completion: 2023-03-20
• Study Completion: 2023-03-20
• Status Verified: 2023-10
• Study First Submitted: 2023-10-28
• Study First Submitted QC: 2023-11-01
• Last Update Submitted: 2023-11-01
• Study First Posted: 2023-11-02
• Last Update Posted: 2023-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Adult patients over 18 years, scheduled for primary elective shoulder arthroplasty surgery.

Read More

Exclusion Criteria

Exclusion criteria were previous allergic reaction or perceived adverse effects of chlorhexidine, prolonged treatment with cortisone (>5 mg), antibiotic treatment within 14 days prior to scheduled surgery, skin disease or ongoing skin infection.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Chlorhexidine	Sodium Chloride	Postoperative disinfection
Sodium Chloride	Sodium Chloride	Postoperative disinfection

Primary Outcome Measures

Name	Time	Method
Bacterial colonization	At 48 hours after shoulder surgery

Trial Locations

Locations (1)

Ryhov Hospital; 🇸🇪 Jönköping, Småland, Sweden