Impact of Postoperative Skin Disinfection With Chlorhexidine on Bacterial Colonization

Surgical Site Infection Clinical Trial

Official title:

Impact of Postoperative Skin Disinfection With Chlorhexidine on Bacterial Colonization Following Shoulder Arthroplasty Surgery: A Controlled Randomized Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06114459
• Other study ID #: 780727
• Status: Completed
• Phase: Phase 4
• Start date: August 10, 2019
• Est. completion date: March 20, 2023

Study information

• Verified date: October 2023
• Source: Linkoeping University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

METHOD Study design

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

Sample and setting Participants was recruited at one county hospital in the southeast of Sweden from august 2019 to mars 2023. Consecutive sampling of adult patients over 18 years of age scheduled for primary elective shoulder arthroplasty surgery was approached for participation.

Intervention According to a predetermined schedule, the surgery site was either disinfected with 5 mg chlorhexidine in 70% ethanol or cleaned with sterile sodium chloride, Skin samples Skin swabs were collected on four occasions: 1. Baseline, 2. After skin disinfection, 3. Post-intervention, and 4. After 48 hours. All samples in the study were collected utilizing the eSwab system with flocked swabs Two swabs were collected on each occasion. The Pencil Eraser Swab (PES)- technique was employed (26). Swabs were gently rubbed in an oscillating motion, moving downward, and then replicating the same motion upward, repeated 15 times. For sample 1 and 2, one swab on each side of the intended incision site was collected. For samples 3 and 4, swabs were taken from each sides of the incision, positioned 1 cm away from the sutures or staples, with one swab collected on each side

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 20, 2023
• Est. primary completion date: March 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

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.

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Related Conditions & MeSH terms

• Surgical Site Infection
• Surgical Wound Infection

Intervention

Drug:
• Sodium Chloride
Post surgery disinfection

Locations

Country	Name	City	State
Sweden	Ryhov Hospital	Jönköping	Småland

Sponsors (1)

Lead Sponsor	Collaborator
Linkoeping University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bacterial colonization		At 48 hours after shoulder surgery