Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT06114459 |
Other study ID # |
780727 |
Secondary ID |
|
Status |
Completed |
Phase |
Phase 4
|
First received |
|
Last updated |
|
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 |
Health authority |
|
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