How to Prevent Post-surgery Infections
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorI.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
About this trial
Evaluation of the effectiveness in reducing the bacterial load on the skin of bedridden opatients through the use of two different cleaning and washing systems (swash bathing gloves vs pre-soaped sponges). The evaluation will be carried out on a daily basis and will begin on the first day after surgery for 3 consecutive days
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age over 18 -
Both sexes
ASA III with need of monitoring
Major surgery (Hip, Knee- Shoulder-first or revision)
Disqualifiers
Lack of consent
Poor cooperation
Post-operative delirium
Pregnant women
Trial design
Design model
Parallel
Treatments tested in this trial
Swab for cleaning, used as first comparator. For this group we want, during these three days and each day, measure skin pH before and after, Coltural exam before and after and time for cleaning
Procedure/SurgeryThe method will be the same of the swab arm. The goal is to compare the two groups looking at any differences
sham group with sponge for skin detersion
Procedure/SurgeryProcedure/Surgery: Sponge group: Use of this device for skin detersion, measuring also pH test and coltural examination before and after cleaning Description: we want to compare sponge detersion in bedridden patient, looking at pH test and coltural examination before and after surgery
Treatment groups
164 Participants
are divided into 2 treatment groupsGroup A: Swab washing group, that means we want to use a specific swab for cleaningActive comparator 1 intervention
Group B: Pre-soaped sponges, using an usual methods for skin cleaningSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Evaluation of the effectiveness in reducing the bacterial load on the skin of bedridden patients through the use of two different cleaning and washing systems
for three consecutive days, after surgery, we measure skin pH before and after cleaning with swab, to evaluate any variation (acid vs basic). We collect coltural exam before and after cleaning, to evaluate change in bacterial charge. Finally to measure time for cleaning and satisfaction of the patient
Time frame
18 months2
Evaluation of effectiveness in reducing the bacterial load on the skin of bedridden patient,. Before and after this procedure we want to measure pH of the skin and coltural skin exam to evaluate difference between groups
This evaluation will be carried out on a daily frequence and will begin on the first day after surgery and for three days
Time frame
From the first day after surgery until a 30 days follow upSecondary outcomes
1
Analysis of patient comfort levels assessed through a questionnaire on comfort during hygiene procedures. Operational efficiency assessed by the ratio of 'time taken/result obtained'
During these three daays a person "blind" of method, will ask patient with an interview finalized to determine what patients think about
Time frame
three days for each patient of the two groups, plus a follow up 30 days afetr surgerySponsors and contacts
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Source ClinicalTrials.gov