Recolonization Following Preoperative Disinfection Plastic Adhesive Drapes
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ClinicalTrials.gov Identifier: NCT01316588 |
Recruitment Status
:
Completed
First Posted
: March 16, 2011
Last Update Posted
: April 19, 2016
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Surgical Wound Infection | Other: Plastic adesive drape Other: Microbial Sealant | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 140 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Prevention |
Official Title: | Recolonization of the Skin Following Pre-operative Disinfection and Impact of the Use of Plastic Adhesive Drapes |
Study Start Date : | August 2010 |
Actual Primary Completion Date : | October 2011 |
Actual Study Completion Date : | October 2011 |

Arm | Intervention/treatment |
---|---|
Experimental: Plastic adesive drape
Intraoperative: Plastic adhesive drape on the chest and bare skin on the leg
|
Other: Plastic adesive drape
Plastic adhesive drape intraoperatively on patients skin around the surgical wound on the chest and bare skin on the leg
|
Experimental: Microbial Sealant
Intraoperative: Microbial Sealant on the leg and bare skin on the chest
|
Other: Microbial Sealant
Microbial sealant intraoperatively on patients skin around the surgical wound on the leg and bare skin on the chest
|
- Bacterial samples [ Time Frame: 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.
- Surgical site infection [ Time Frame: once ]ASEPSIS score will be measured after 2 months

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Elective CABG and/or AVR
Exclusion Criteria:
Suffer from any recent infection two weeks prior to the start of the trial

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01316588
Sweden | |
Orebro University, Faculty of medicine and Health | |
Örebro, Sweden, 70182 |
Principal Investigator: | Ulrica Nilsson, PhD, Professor | Örebro University, faculty of Medicine and Health , Sweden |
Publications of Results:
Responsible Party: | Ulrica Nilsson, Professor, Örebro University, Sweden |
ClinicalTrials.gov Identifier: | NCT01316588 History of Changes |
Other Study ID Numbers: |
2010/46 |
First Posted: | March 16, 2011 Key Record Dates |
Last Update Posted: | April 19, 2016 |
Last Verified: | April 2016 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Keywords provided by Ulrica Nilsson, Örebro University, Sweden:
recolonization Plastic adhesive drape microbial sealant SSI bacterial growth |
Additional relevant MeSH terms:
Wound Infection Surgical Wound Surgical Wound Infection Infection |
Wounds and Injuries Postoperative Complications Pathologic Processes |