Impact of Postoperative Skin Disinfection With Chlorhexidine on Bacterial Colonization

Sponsor

Linkoeping University (Other)

Overall Status

Completed

CT.gov ID

NCT06114459

Collaborator

(none)

Enrollment

Location

Arms

43.3

Actual Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Surgical Site Infection	Drug: Sodium Chloride	Phase 4

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

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Aug 10, 2019

Actual Primary Completion Date :

Mar 20, 2023

Actual Study Completion Date :

Mar 20, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Chlorhexidine Postoperative disinfection	Drug: Sodium Chloride Post surgery disinfection
Experimental: Sodium Chloride Postoperative disinfection	Drug: Sodium Chloride Post surgery disinfection

Arm

Intervention/Treatment

Experimental: Chlorhexidine

Postoperative disinfection

Drug: Sodium Chloride

Post surgery disinfection

Experimental: Sodium Chloride

Postoperative disinfection

Drug: Sodium Chloride

Post surgery disinfection

Outcome Measures

Primary Outcome Measures

Bacterial colonization [At 48 hours after shoulder surgery]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ryhov Hospital	Jönköping	Småland	Sweden	60221

Sponsors and Collaborators

Linkoeping University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ida Markstrom, CORN,, Linkoeping University

ClinicalTrials.gov Identifier:

NCT06114459

Other Study ID Numbers:

780727

First Posted:

Nov 2, 2023

Last Update Posted:

Nov 2, 2023

Last Verified:

Oct 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Surgical Wound Infection

Study Results

No Results Posted as of Nov 2, 2023