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

NCT02342561 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2015-12-11

Study results available
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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.

Conditions

  • Total Knee Replacement Surgery

Interventions

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.

Sponsors & Collaborators

  • Odense University Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2015-07-31
Completion
2015-08-31

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02342561 on ClinicalTrials.gov