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| Name | Class |
|---|---|
| Region Örebro County | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Plastic adesive drape | Experimental | Intraoperative: Plastic adhesive drape on the chest and bare skin on the leg |
|
| Microbial Sealant | Experimental | Intraoperative: Microbial Sealant on the leg and bare skin on the chest |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Plastic adesive drape | Other | Plastic adhesive drape intraoperatively on patients skin around the surgical wound on the chest and bare skin on the leg |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Surgical site infection | ASEPSIS score will be measured after 2 months | once |
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Inclusion Criteria:
Elective CABG and/or AVR
Exclusion Criteria:
Suffer from any recent infection two weeks prior to the start of the trial
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| Name | Affiliation | Role |
|---|---|---|
| Ulrica Nilsson, PhD, Professor | Örebro University, faculty of Medicine and Health , Sweden | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orebro University, Faculty of medicine and Health | Örebro | 70182 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24907853 | Result | Falk-Brynhildsen K, Soderquist 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. 2014 Nov;33(11):1981-7. doi: 10.1007/s10096-014-2168-x. Epub 2014 Jun 8. | |
| 24080082 |
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| ID | Term |
|---|---|
| D013530 | Surgical Wound Infection |
| ID | Term |
|---|---|
| D014946 | Wound Infection |
| D007239 | Infections |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
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| Microbial Sealant | Other | Microbial sealant intraoperatively on patients skin around the surgical wound on the leg and bare skin on the chest |
|
| Falk-Brynhildsen K, Soderquist 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. Epub 2013 Sep 17. No abstract available. |
| 23623487 | Result | Falk-Brynhildsen K, Soderquist 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 Jun;84(2):151-8. doi: 10.1016/j.jhin.2013.02.011. Epub 2013 Apr 25. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |