Surgical Site InfectionPhase 4NCT06114459
Impact of Postoperative Skin Disinfection With Chlorhexidine on Bacterial Colonization
A Phase 4 study testing Sodium Chloride in people with Surgical Site Infection, run by Linkoeping University at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgical Site Infection
- What is being tested?
- Sodium Chloride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSweden
- Study dates
- 10 Aug 2019to 20 Mar 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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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Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Postoperative Skin Disinfection With Chlorhexidine on Bacterial Colonization Following Shoulder Arthroplasty Surgery: A Controlled Randomized Study
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.
Read the 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
- Conditions
- Surgical Site Infection
- Being tested
- Sodium Chloride
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium ChlorideDrug
Post surgery disinfection
| Study group | Role | What they receive |
|---|---|---|
| Chlorhexidine | Experimental | Postoperative disinfection Receives: Drug: Sodium Chloride |
| Sodium Chloride | Experimental | Postoperative disinfection Receives: Drug: Sodium Chloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bacterial colonization
Measured: At 48 hours after shoulder surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2023
- Study start10 Aug 2019
- Primary completion20 Mar 2023
- Study completion20 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Site InfectionStudies of the same condition, open and under way.
- More trials run by Linkoeping UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Linkoeping University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ida Markstrom, Linkoeping University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06114459
- Sponsor's protocol ID
- 780727
- Status last verified
- Oct 2023
- First submitted
- 28 Oct 2023
- Last updated
- 2 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Postoperative Skin Disinfection With Chlorhexidine on Bacterial Colonization Following Shoulder Arthroplasty Surgery: A Controlled Randomized Study
- ClinicalTrials.gov ID
- NCT06114459
- Acronym / sponsor ID
- 780727
- Conditions
- Surgical Site Infection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Linkoeping UniversityOther government
- Study start
- 10 Aug 2019 (actual)
- Primary completion
- 20 Mar 2023 (actual)
- Study completion
- 20 Mar 2023 (actual)
- First posted
- 2 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chlorhexidine | Experimental | Drug: Sodium ChloridePostoperative disinfection |
| Sodium Chloride | Experimental | Drug: Sodium ChloridePostoperative disinfection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sodium ChloridePost surgery disinfection | Drug | Chlorhexidine, Sodium Chloride |
Primary outcome
Bacterial colonization
Time frame: At 48 hours after shoulder surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sodium Chloride in people with Surgical Site Infection, run by Linkoeping University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bacterial colonization (time frame: At 48 hours after shoulder surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2023.