N/A N=20 Randomized Prevention

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

Total Knee Replacement Surgery

Bottom Line

View on ClinicalTrials.gov: NCT02342561 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2015

Primary outcome: Primary: Bacterial Quantity — 0.26; 0.32; 0.0; 0.26 Log10 CFU/cm^2 — p=0.601

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Ioban 2 incision drape, 3M (Device)
Age: Adult, Older Adult · 50+ yrs
Sex: All
Sponsor: Odense University Hospital
Primary completion: Jul 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Bacterial Quantity	0.26; 0.32; 0.0; 0.26	0.601
SECONDARY Description of Bacterial Skin Flora	7; 5; 0; 0; 2; 0	0.731

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.

Eligibility 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.

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Data sourced from ClinicalTrials.gov (NCT02342561). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.