A Phase 3 interventional study of Plastic adesive drape and Microbial Sealant in Surgical Wound Infection, sponsored by Örebro University, Sweden. Completed at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-04-19.
Sponsored by Örebro University, Sweden · Phase 3, Interventional, and Prevention
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.
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.
687 studies on the registry are indexed under Surgical Wound Infection; 142 are open to participants now.
This study's enrollment of 140 is below the median of 200 across 526 interventional studies indexed under Surgical Wound Infection.
Browse Surgical Wound Infection studies →Örebro University, Sweden is the lead sponsor of 86 studies on the registry; 14 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Elective CABG and/or AVR
Exclusion Criteria:
Suffer from any recent infection two weeks prior to the start of the trial
Intraoperative: Plastic adhesive drape on the chest and bare skin on the leg
Other: Plastic adesive drape
Intraoperative: Microbial Sealant on the leg and bare skin on the chest
Other: Microbial Sealant
Plastic adhesive drape intraoperatively on patients skin around the surgical wound on the chest and bare skin on the leg
Microbial sealant intraoperatively on patients skin around the surgical wound on the leg and bare skin on the chest
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.
Time frame: Bacterial samples are taken on eight occasionson the chest and at five occations
Surgical site infection
ASEPSIS score will be measured after 2 months
Time frame: once
Plan to share: No
The record gives a start of Aug 2010, a primary completion of Oct 2011 and a completion of Oct 2011. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Örebro University, Sweden