Recolonization Following Preoperative Disinfection Plastic Adhesive Drapes

Surgical Wound Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01316588
• Other study ID #: 2010/46
• Status: Completed
• Phase: Phase 3
• First received: March 11, 2011
• Last updated: April 18, 2016
• Start date: August 2010
• Est. completion date: October 2011

Study information

• Verified date: April 2016
• Source: Örebro University, Sweden
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Surgical Wound Infection
• Wound Infection

Intervention

Other:
• Plastic adesive drape
Plastic adhesive drape intraoperatively on patients skin around the surgical wound on the chest and bare skin on the leg
• Microbial Sealant
Microbial sealant intraoperatively on patients skin around the surgical wound on the leg and bare skin on the chest

Locations

Country	Name	City	State
Sweden	Orebro University, Faculty of medicine and Health	Örebro

Sponsors (2)

Lead Sponsor	Collaborator
Örebro University, Sweden	University Hospital Orebro

Country where clinical trial is conducted

Sweden, 

References & Publications (3)

Falk-Brynhildsen K, Söderquist B, Friberg O, Nilsson U. Bacterial growth and wound infection following saphenous vein harvesting in cardiac surgery: a randomized controlled trial of the impact of microbial skin sealant. Eur J Clin Microbiol Infect Dis. 20 — View Citation

Falk-Brynhildsen K, Söderquist B, Friberg O, Nilsson UG. Bacterial recolonization of the skin and wound contamination during cardiac surgery: a randomized controlled trial of the use of plastic adhesive drape compared with bare skin. J Hosp Infect. 2013 J — View Citation

Falk-Brynhildsen K, Söderquist B, Friberg O, Nilsson UG. Response to M.H. Stevens and N.M. Klinger, re: Bacterial recolonization of the skin and wound contamination during cardiac surgery. J Hosp Infect. 2013 Dec;85(4):325. doi: 10.1016/j.jhin.2013.09.001 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bacterial samples	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.	Bacterial samples are taken on eight occasionson the chest and at five occations	Yes
Secondary	Surgical site infection	ASEPSIS score will be measured after 2 months	once	Yes