NCT02260479

Brief Summary

The primary aim was to investigate if preheated skin disinfection with Chlorhexidine in alcohol was non-inferior compared to room-temperature regarding skin colonization as well as bacterial colonization in wound, skin temperature and patients experiences.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
220

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2013

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

January 1, 2013

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

October 6, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 9, 2014

Completed
23 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

January 28, 2015

Status Verified

January 1, 2015

Enrollment Period

1.8 years

First QC Date

October 6, 2014

Last Update Submit

January 27, 2015

Conditions

Colonization

Keywords

skin disinfectionbacterial colonizationperioperativechlorehexidine

Outcome Measures

Primary Outcomes (1)

  • Bacterial cultures

    Skin cultures (eSwab) taken before and after skin disinfection

    perioperative

Secondary Outcomes (4)

  • Surgical site infections

    Three month after surgery

  • bacterial colonization in wound

    perioperative

  • Skin temperature

    perioperative

  • Patients experience of skin disinfection

    Perioperative

Study Arms (2)

Preheated chlorhexidine

ACTIVE COMPARATOR

Preheated skin disinfection with 36ᵒC Chlorhexidine 5mg/ml in 70% alcohol.

Procedure: Preheated

Room temperature chorhexidine

NO INTERVENTION

Room temperature skin disinfection with 20ᵒC Chlorhexidine 5mg/ml in 70% alcohol.

Interventions

PreheatedPROCEDURE

Skin disinfection solution is preheated in a warming cupboard

Preheated chlorhexidine

Eligibility Criteria

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

You may qualify if:

  • could read and understand Swedish

You may not qualify if:

  • infection in existing implanted device

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Wistrand C, Nilsson U, Sundqvist AS. Patient experience of preheated and room temperature skin disinfection prior to cardiac device implantation: A randomised controlled trial. Eur J Cardiovasc Nurs. 2020 Aug;19(6):529-536. doi: 10.1177/1474515119900062. Epub 2020 Feb 7.

    PMID: 32028795DERIVED

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Operating room nurse

Study Record Dates

First Submitted

October 6, 2014

First Posted

October 9, 2014

Study Start

January 1, 2013

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

January 28, 2015

Record last verified: 2015-01