Iodine Impregnated Incision Drapes and Bacterial Recolonization in Simulated Knee Surgery. A Controlled Randomized Experimental Trial.
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|ClinicalTrials.gov Identifier: NCT02342561|
Recruitment Status : Completed
First Posted : January 21, 2015
Results First Posted : December 11, 2015
Last Update Posted : December 11, 2015
This study evaluates the effect of Iodine-impregnated self-adhesive plastic drapes (IIAD) on the quantity of skin bacteria, which is a known factor in the development of surgical site infections in orthopedic surgery. 16 patients scheduled for total knee replacement surgery (TKA) are recruited for participation in an intervention performed at the orthopedic ward of Odense University Hospital, Denmark.
Right or left patient knee is randomized to receive draping with IIAD, while the other knee is not draped. Local standard preoperative procedure for knee surgery is then simulated.
After 75 minutes both knee are sampled for bacterial quantity using the cup scrub method and samples are aerobically incubated. The bacterial growth of the IIAD and no-drape group are then compared using nonparametric statistics.
|Condition or disease||Intervention/treatment||Phase|
|Total Knee Replacement Surgery||Device: Ioban 2 incision drape, 3M||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Iodine Impregnated Incision Drapes and Bacterial Recolonization in Simulated Total Knee Arthroplasty. A Controlled Randomized Experimental Trial.|
|Study Start Date :||September 2014|
|Actual Primary Completion Date :||July 2015|
|Actual Study Completion Date :||August 2015|
Experimental: Intervention knees (Drape side)
One knee of the patient is randomly selected to be drape with an Ioban 2 incision drape.
Device: Ioban 2 incision drape, 3M
The anterior knee of the patient is covered with an Ioban 2 drape for 75 minutes. The drape is applied and removed in accordance with product instructions.
Other Name: Ioban 2 antimicrobial incision drape, 3M
No Intervention: Control knees (no-drape side)
The knee that is not drape is left uncovered during the intervention.
- Bacterial Quantity [ Time Frame: Measured after skin disinfection and 75 minutes after drape application ]The bacterial quantity of the skin in sampled using the cylinder sampling method and incubated for 36-48 hours. Manually counted growth is reported as log10 Colony forming units (CFU)/cm^2
- Description of Bacterial Skin Flora [ Time Frame: Samples collected 75 minutes after drape application are analysed ]Macroscopically unique colonies are isolated and analysed using Matrix-Assisted Laser Desorption/Ionization Time Of Flight analysis (MALDI-TOF). Finding are reported as prevalence of unique organism growth in the study population
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): NCT02342561
|Ortopeadic research Unit, Odense University Hospital|
|Odense, Denmark, 5000|