Recolonization Following Preoperative Disinfection Plastic Adhesive Drapes

Recolonization of the Skin Following Pre-operative Disinfection and Impact of the Use of Plastic Adhesive Drapes

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01316588

Enrollment

140

Registered

2011-03-16

Start date

2010-08-31

Completion date

2011-10-31

Last updated

2016-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Surgical Wound Infection

Keywords

recolonization, Plastic adhesive drape, microbial sealant, SSI, bacterial growth

Brief summary

The purpose of this study is to measure the time to recolonization intraoperatively after preoperative disinfection with chlorhexidine solution in ethanol and to determine evidence of differential bacterial growth with or without plastic adhesive drape on the chest as well as with or without microbial sealant on the leg.

Detailed description

The purpose of this study is to measure the time to recolonization intraoperative after preoperative disinfection with chlorhexidine solution in ethanol and to determine evidence of differential bacterial growth with or without plastic adhesive drape as well as with or without microbial sealant on the leg. A RCT study of 140 patients undergoing coronary artery bypass grafting (CABG) and/or aortic valve replacement (AVR) are included. The investigators test the hypothesis that patients randomized to no plastic adhesive drape intraoperatively will have a reduced recolonisation compared to patients with plastic adhesive drape.

Interventions

OTHERPlastic adesive drape

Plastic adhesive drape intraoperatively on patients skin around the surgical wound on the chest and bare skin on the leg

OTHERMicrobial Sealant

Microbial sealant intraoperatively on patients skin around the surgical wound on the leg and bare skin on the chest

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Elective CABG and/or AVR

Exclusion criteria

Suffer from any recent infection two weeks prior to the start of the trial

Design outcomes

Primary

Measure	Time frame	Description
Bacterial samples	Bacterial samples are taken on eight occasionson the chest and at five occations	Bacterial samples on the skin of the chest: one day before surgery, the day of surgery, and immediately after disinfection. Thereafter five times both on the skin and in the surgical wound i.e. 60, 120, 180 and 240 minutes intraoperatively as well as at the closure of the surgical wound. Bacterial samples on the leg: one day before surgery, the day of surgery, and immediately after disinfection. Thereafter at two occasions both : on the skin and in the surgical wound i.e. at the incision and at the closure of the surgical wound.

Secondary

Measure	Time frame	Description
Surgical site infection	once	ASEPSIS score will be measured after 2 months

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026