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Impact of Postoperative Skin Disinfection With Chlorhexidine on Bacterial Colonization

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06114459
Enrollment
60
Registered
2023-11-02
Start date
2019-08-10
Completion date
2023-03-20
Last updated
2023-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Surgical Site Infection

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. 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

Interventions

DRUGSodium Chloride

Post surgery disinfection

Sponsors

Linkoeping University
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Bacterial colonizationAt 48 hours after shoulder surgery

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026