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Trial record 78 of 10491 for:    Anti-Infective Agents AND Bacterial

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
Sponsor:
Information provided by (Responsible Party):
Nikolaj Milandt, Odense University Hospital

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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



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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient is scheduled for primary knee replacement surgery (TKA).

Exclusion Criteria:

  • Patient age under 50 year
  • Patient is allergic to iodine
  • Patient has received antibiotic treatment within 4 weeks of intervention.
  • Patient suffers from a chronic skin disease with lesions in the knee area
  • Patient has lesions of the skin due to trauma suffered within 1 week of intervention.

Information from the National Library of Medicine

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


Locations
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Denmark
Ortopeadic research Unit, Odense University Hospital
Odense, Denmark, 5000
Sponsors and Collaborators
Odense University Hospital

Publications:
Brush M. Surgical preparation and site acces: Testing´s stepchild. In: Paulson DS, editor. Handbook of topical antimicrobials: Industrial applications in consumer products and pharmaceutical. New York: Marcel Dekker Inc; 2003. p. 197-220.
3M HC. 3M incise drapes 2014 [cited 2014 Oktober 29th]. Available from: http://solutions.3m.com/wps/portal/3M/en_US/IPD-NA/3M-Infection-Prevention/products/catalog/~/All-3M-Products/Industry-and-Professionals/Medical-Supplies-Software/Infection-Prevention-Products/Incise-Drapes?N=5716450&rt=c3.
Danish Orthopeadic Society. Reference program, Primary knee arthroplastic surgery. 2007.
Sogawa Y, Kobayashi H. Comparison of residual antimicrobial activity of chlorhexidine-containing antiseptics: An express report. Journal of Healthcare-associated Infection. 2010;2:32-6.
Beausoleil CM. A guide for validation of neutralizer systems. In: Paulson DS, editor. Handbook of topical antimicrobials: Industrial applications in consumer products and pharmaceutical. New York: Marcel Dekker Inc; 2003. p. 365-76.
Cecilio. RL PF, Palileo. E,. Microbiological efficacy of Chlorhexidine: An In Vitro Study on 400 Bacterial Isolates from Four Metro Manila Hospitals. Phil J Microbial Dis. 1983;12:7-13.

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Responsible Party: Nikolaj Milandt, stud. cand. med, BA Clinical Biomechanics, Odense University Hospital
ClinicalTrials.gov Identifier: NCT02342561     History of Changes
Other Study ID Numbers: S-20140060
First Posted: January 21, 2015    Key Record Dates
Results First Posted: December 11, 2015
Last Update Posted: December 11, 2015
Last Verified: November 2015

Keywords provided by Nikolaj Milandt, Odense University Hospital:
Infection
Drape
Ioban
Arthroplasty
Knee
Cylinder Sampling
Bacteria