NCT06114459

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Aug 2019

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 10, 2019

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2023

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

October 28, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 2, 2023

Completed
Last Updated

November 2, 2023

Status Verified

October 1, 2023

Enrollment Period

3.6 years

First QC Date

October 28, 2023

Last Update Submit

November 1, 2023

Conditions

Surgical Site Infection

Outcome Measures

Primary Outcomes (1)

  • Bacterial colonization

    At 48 hours after shoulder surgery

Study Arms (2)

Chlorhexidine

EXPERIMENTAL

Postoperative disinfection

Drug: Sodium Chloride

Sodium Chloride

EXPERIMENTAL

Postoperative disinfection

Drug: Sodium Chloride

Interventions

Sodium ChlorideDRUG

Post surgery disinfection

ChlorhexidineSodium Chloride

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ryhov Hospital

Jönköping, Småland, 60221, Sweden

Location

MeSH Terms

Conditions

Surgical Wound Infection

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Wound InfectionInfectionsPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
CORN,

Study Record Dates

First Submitted

October 28, 2023

First Posted

November 2, 2023

Study Start

August 10, 2019

Primary Completion

March 20, 2023

Study Completion

March 20, 2023

Last Updated

November 2, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)