Preheated Skin Disinfection vs Room-temperature on Bacterial Colonization During Pace Device Implantation

The Effect of Preheated Skin Disinfection in Relation to Room-temperature Skin Disinfection on Bacterial Colonization During Pace Device Implantation: a Randomized Controlled Non-inferiority Trial.

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.

Study Overview

• Status: Completed
• Conditions: Colonization
• Intervention / Treatment: Procedure: Preheated

Detailed Description

Patients were randomly assigned to preheated (36ᵒC, intervention) skin disinfection (Chlorhexidine 5mg/ml in 70% alcohol) or room temperature (20ᵒC, control) skin disinfection (Chlorhexidine 5mg/ml in 70% alcohol). Patient´s enrollment to operation was made by an external controller who had no closer knowledge of present study. All patients were asked to participate in that sequence they arrived to the OR department when study nurse was present. Assignment took place directly after patients consent. Patients were stratified into gender and thereafter randomly allocated to preheated or control group, based on a computer-generated randomization list made by an independent statistician. Patients showered, scrubbing their whole body and hair twice with 4% chlorhexidine soap Descutan® (Fresenius Kabi AB, Uppsala, Sweden) prior to surgery. and patients were prepared after skin disinfection with a microbial sealant. Most patients were elective and arrived the morning of surgery to the hospital. Following standard procedures, intravenously administered antibiotic prophylaxis (cloxacillin 2 g) was administrated at the ward 30 minutes before surgery. In the OR the patients wore a disposable cap and were positioned on the operating table. The OR temperature were 19°C with upward displacement ventilation. Sterile disposable surgical gowns (Samutprakarn, Thailand/Mölnlycke Health Care AB, Göteborg, Sweden) and indicator gloves (Selangor, Malaysia/Mölnlycke Health Care AB Göteborg, Sweden) were worn by the surgeon and OR nurse. Other OR staff (n=2) wore cotton scrubs, short-sleeved tunic shirt with cuffs at the arms, and trousers with cuffs at the ankles. They also wore disposable helmets and facemasks. Both groups were given skin disinfection during 2 minutes with the same amount of solution (Chlorhexidine 5mg/ml in 70% alcohol). The skin disinfection (Chlorhexidine 5mg/ml, in alcohol) was stored in room-temperature and was measured to keep 20ᵒC while the preheated was stored in a warming cupboard who kept 36ᵒC. The participants were disinfected from cheek down over sternum according to routine procedures. Sterile material for draping and clothing were for single use only. Cultures were obtained at four occasions using a nylon flocked swab (Copan ESwab, Italia SpA): before skin disinfection on skin surface; after skin disinfection on skin surface; directly after the incision, at completion of the incision, and finally before start of closing sutures. Swab cultures were rubbed for 15 seconds slightly moist with saline on skin surface (incision site). Swabs taken in the wound were rubbed along the inside of the incision for 15 seconds with a dry swab. Surgery was performed by two cardiologists. Cultures were kept cold until arrival at the Department of Laboratory medicine, Clinical Microbiology. Cultures were taken care of and analyzed according to a specific protocol designed especially for the study.

• Study Type: Interventional
• Enrollment (Actual): 220
• Phase: Phase 2; Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• could read and understand Swedish

Exclusion Criteria:

• infection in existing implanted device

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Preheated chlorhexidine; Preheated skin disinfection with 36ᵒC Chlorhexidine 5mg/ml in 70% alcohol.	Procedure: Preheated; Skin disinfection solution is preheated in a warming cupboard
No Intervention: Room temperature chorhexidine; Room temperature skin disinfection with 20ᵒC Chlorhexidine 5mg/ml in 70% alcohol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bacterial cultures	Skin cultures (eSwab) taken before and after skin disinfection	perioperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgical site infections		Three month after surgery
bacterial colonization in wound	Cultures taken in wound at time for incision and before closing sutures	perioperative
Skin temperature	Skin temperature was taken before and after skin disinfection	perioperative
Patients experience of skin disinfection	Numerical rating scale, 0-10 (0=pleasant-10=unpleasant)	Perioperative

Collaborators and Investigators

• Sponsor: Örebro University, Sweden

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): November 1, 2014
• Study Completion (Actual): November 1, 2014

Study Registration Dates

• First Submitted: October 6, 2014
• First Submitted That Met QC Criteria: October 8, 2014
• First Posted (Estimate): October 9, 2014

Study Record Updates

• Last Update Posted (Estimate): January 28, 2015
• Last Update Submitted That Met QC Criteria: January 27, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Keywords: perioperative; skin disinfection; bacterial colonization; chlorehexidine
• Other Study ID Numbers: OpPm2013

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No