Recolonization Following Preoperative Disinfection Plastic Adhesive Drapes

Phase 3

Completed

• Conditions: Surgical Wound Infection
• Interventions: Other: Plastic adesive drape; Other: Microbial Sealant

• Registration Number: NCT01316588
• Lead Sponsor: Örebro University, Sweden

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.

Study Timeline

• Study Start: 2010-08
• Study First Submitted: 2011-03-11
• Study First Submitted QC: 2011-03-15
• Study First Posted: 2011-03-16
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-18
• Last Update Posted: 2016-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

Elective CABG and/or AVR

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Plastic adesive drape	Plastic adesive drape	Intraoperative: Plastic adhesive drape on the chest and bare skin on the leg
Microbial Sealant	Microbial Sealant	Intraoperative: Microbial Sealant on the leg and bare skin on the chest

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Surgical site infection	once	ASEPSIS score will be measured after 2 months

Trial Locations

Locations (1)

Orebro University, Faculty of medicine and Health; 🇸🇪 Örebro, Sweden