Trial Outcomes & Findings for Iodine Impregnated Incision Drapes and Bacterial Recolonization in Simulated Knee Surgery. A Controlled Randomized Experimental Trial. (NCT NCT02342561)

NCT ID: NCT02342561

Last Updated: 2015-12-11

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 20 participants
• Primary outcome timeframe: Measured after skin disinfection and 75 minutes after drape application
• Results posted on: 2015-12-11

Participant Flow

Participant milestones

Measure	Intervention Knee (Drape Side) and Control Knee (No Drape Side One knee of the patient is randomly selected to be drape with an Ioban 2 incision drape. 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. The control knee that is not drape is left uncovered during the intervention.
Overall Study STARTED	20
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Iodine Impregnated Incision Drapes and Bacterial Recolonization in Simulated Knee Surgery. A Controlled Randomized Experimental Trial.

Baseline characteristics by cohort

Measure	Intervention Knees (Draped Knees) and Control Knees (No-draped n=20 Participants One knee of the patient is randomly selected to be drape with an Ioban 2 incision drape. 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. The knee that is not drape is left uncovered during the intervention.
Age, Continuous	67.8 years STANDARD_DEVIATION 9.7 • n=93 Participants
Sex: Female, Male Female	13 Participants n=93 Participants
Sex: Female, Male Male	7 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants
Race (NIH/OMB) White	20 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Region of Enrollment Denmark	20 participants n=93 Participants
Bacterial growth prior disinfection (colony forming unit/cm^2, Log10 transformed) Intervention knees (Draped Knees)	2.99 Log10 CFU/cm^2 n=93 Participants
Bacterial growth prior disinfection (colony forming unit/cm^2, Log10 transformed) Control knees (no drape knees)	2.91 Log10 CFU/cm^2 n=93 Participants
Bacterial growth prior disinfection (colony forming unit/cm^2, Log10 transformed) Both groups combined	2.97 Log10 CFU/cm^2 n=93 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	Intervention Knee (Draped Knees) n=20 Participants One knee of the patient is randomly selected to be drape with an Ioban 2 incision drape. 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.	Control Knee (No-drape Knees) n=20 Participants The knee that is not drape is left uncovered during the intervention.
Bacterial Quantity After skin disinfection	0.26 Log10 CFU/cm^2 Interval 0.0 to 0.63	0.32 Log10 CFU/cm^2 Interval 0.0 to 0.94
Bacterial Quantity At end of surgery (drape removal)	0.0 Log10 CFU/cm^2 Interval 0.0 to 0.94	0.26 Log10 CFU/cm^2 Interval 0.0 to 0.73

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Intervention Knee (Draped Knees) n=20 Participants One knee of the patient is randomly selected to be drape with an Ioban 2 incision drape. 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.	Control Knee (No-drape Knees) n=20 Participants The knee that is not drape is left uncovered during the intervention.
Description of Bacterial Skin Flora Prevalence of Corynebacterium growth	2 No. of cases	0 No. of cases
Description of Bacterial Skin Flora Prevalence of Coagulase negative staph growth	7 No. of cases	5 No. of cases
Description of Bacterial Skin Flora Prevalence of Staph. Aureus growth	0 No. of cases	0 No. of cases
Description of Bacterial Skin Flora Prevalence of Enterococci growth	0 No. of cases	0 No. of cases
Description of Bacterial Skin Flora Prevalence of E.coli growth	0 No. of cases	0 No. of cases

Adverse Events

Intervention Knees

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Knees

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Nikolaj Milandt, Undergraduate researcher

The Orthopaedic Research Unit, Department of Orthopaedic Surgery and Trauma, Odense University Hospital, Denmark

Phone: 26616611

Email: nikolaj.rongsted.milandt@rsyd.dk

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place