CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 20 enrolled
Drug / intervention
Ioban 2 incision drape, 3Mdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02342561
NCT02342561N/ACompleted
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Iodine Impregnated Incision Drapes and Bacterial Recolonization in Simulated Total Knee Arthroplasty. A Controlled Randomized Experimental Trial.

Odense University Hospital·interventional·Posted Jan 21, 2015·Updated Dec 11, 2015

In Brief

A clinical study evaluating Ioban 2 incision drape, 3M for Total Knee Replacement Surgery. Completed, enrolled 20 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTotal Knee Replacement Surgery
CountriesDenmark
Collaborators--

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedJan 21, 2015
Enrollment StartSep 1, 2014
Primary CompletionJul 1, 2015
Study CompletionAug 1, 2015
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 11.4 years ago

Interventions

Ioban 2 incision drape, 3Mdevice

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.