ASA IIIBundleNCT07848269
How to Prevent Post-surgery Infections
A study testing 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 in people with ASA III and Elective Prosthetic Surgery, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 1 site in Italy.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ASA III, Elective Prosthetic Surgery, Patient Bedridden After Surgery
- What is being tested?
- 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
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 164 participants
- Where
- 1 siteItaly
- Study dates
- 20 Sep 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age over 18 -
- Both sexes
- ASA III with need of monitoring
- Major surgery (Hip, Knee- Shoulder-first or revision)
Who cannot join
- Lack of consent
- Poor cooperation
- Post-operative delirium
- Pregnant women
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Elena Cittera contact
About this study
Official title: Evaluation of a Bundle of Actions to Prevent Skin Infections
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
Read the detailed description
Since bed is recognized as a critical time for the onset of skin superinfections, the study aims to evaluate, by comparison, two different methods of managing bedridden patients using time spent for hygiene, daily skin pH measurement and samples for cilture tests
- Being tested
- 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, sham group with sponge for skin detersion
- Keywords
- Cleaning swab, Sponge swab, ASA III, Skin pH
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 cleaningProcedure or surgery
Also called Sponge for cleaning, used as sham comparator
The 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 detersionProcedure or surgery
Procedure/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
| Study group | Role | What they receive |
|---|---|---|
| Swab washing group, that means we want to use a specific swab for cleaning | Active comparator | Evaluation of the effectiveness in reducing the bacterial load on the skin of bedridden patients . The evaluations will be carried out on a daily basis and will begin on the first day after surgery for 3 consecutive days. Evaluation is comprehensive of pH value before and after cleaning and cultural exam before and after Receives: Procedure: 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 |
| Pre-soaped sponges, using an usual methods for skin cleaning | Sham comparator | Evaluation of the effectiveness in reducing the bacterial load on the skin of bedridden patients . The evaluations will be carried out on a daily basis and will begin on the first day after surgery for 3 consecutive days. Evaluation is comprehensive of pH value before and after cleaning and cultural exam before and after Receives: Procedure: sham group with sponge for skin detersion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 . Two different devices (swab vs sponge) will be compared.
Evaluation of pH before and after cleaning activity looking at the pH skin (using a dedicated device) and coltural charge befdore and after cleaning.
These tests will be done three days after surgery, and the results will be collected in an Excel file to prepare a future analysis
Measured: 18 months
Secondary outcomes (1)
Evaluation of time spent for cleaning and patient satisfaction using one device for three days. The device choice is depending on randomization file and the evaluator is blind of the device used
This evaluation will be carried out on a daily frequence and will begin on the first day after surgery and for three days
Measured: three days for each patient of the two groups, plus a follow up 30 days afetr surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2026
- Study start20 Sep 2026
- Primary completion1 Mar 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ASA IIIStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Adult bedridden patients who are potentially critical due to coexisting diseases such they are classified as ASA 3. A total of 164 subjeill be enrolled and randomised in two groups. Skin pH measurement, collection of sample for culture tests are considered
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 164 participants (estimated)
Sponsor and investigators
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elena Cittera, I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
- Investigators
- Giorgio Oriani, Principal investigator, IRCCS OGSA - Site Istituto San Siro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07848269
- Sponsor's protocol ID
- Bundle to prevent infection
- Acronym
- Bundle
- Status last verified
- Oct 2026
- First submitted
- 9 Sep 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: If someone will be interested in reproduce this study or proceed in this direction we surely would like to give our data
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Bundle of Actions to Prevent Skin Infections
- ClinicalTrials.gov ID
- NCT07848269
- Acronym / sponsor ID
- Bundle / Bundle to prevent infection
- Keywords
- Cleaning swab, Sponge swab, ASA III, Skin pH
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 164 participants (estimated)
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioUniversity, hospital or other
- Study start
- 20 Sep 2026 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 29 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Since bed is recognized as a critical time for the onset of skin superinfections, the study aims to evaluate, by comparison, two different methods of managing bedridden patients using time spent for hygiene, daily skin pH measurement and samples for cilture tests
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Adult bedridden patients who are potentially critical due to coexisting diseases such they are classified as ASA 3. A total of 164 subjeill be enrolled and randomised in two groups. Skin pH measurement, collection of sample for culture tests are considered
| Arm | Type | Receives |
|---|---|---|
| Swab washing group, that means we want to use a specific swab for cleaning | Active comparator | Procedure: 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 cleaningEvaluation of the effectiveness in reducing the bacterial load on the skin of bedridden patients . The evaluations will be carried out on a daily basis and will begin on the first day after surgery for 3 consecutive days. Evaluation is comprehensive of pH value before and after cleaning and cultural exam before and after |
| Pre-soaped sponges, using an usual methods for skin cleaning | Sham comparator | Procedure: sham group with sponge for skin detersionEvaluation of the effectiveness in reducing the bacterial load on the skin of bedridden patients . The evaluations will be carried out on a daily basis and will begin on the first day after surgery for 3 consecutive days. Evaluation is comprehensive of pH value before and after cleaning and cultural exam before and after |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age over 18 -
- Both sexes
- ASA III with need of monitoring
- Major surgery (Hip, Knee- Shoulder-first or revision)
Key exclusion criteria (4 listed)
- Lack of consent
- Poor cooperation
- Post-operative delirium
- Pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 cleaningAlso: Sponge for cleaning, used as sham comparatorThe method will be the same of the swab arm. The goal is to compare the two groups looking at any differences | Procedure or surgery | Swab washing group, that means we want to use a specific swab for cleaning |
| sham group with sponge for skin detersionProcedure/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 | Procedure or surgery | Pre-soaped sponges, using an usual methods for skin cleaning |
Primary outcome
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 . Two different devices (swab vs sponge) will be compared.
Time frame: 18 months
Evaluation of pH before and after cleaning activity looking at the pH skin (using a dedicated device) and coltural charge befdore and after cleaning. These tests will be done three days after surgery, and the results will be collected in an Excel file to prepare a future analysis
1 secondary outcome
Evaluation of time spent for cleaning and patient satisfaction using one device for three days. The device choice is depending on randomization file and the evaluator is blind of the device used
Time frame: three days for each patient of the two groups, plus a follow up 30 days afetr surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: Yes. If someone will be interested in reproduce this study or proceed in this direction we surely would like to give our data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Elena Cittera contact
Giorgio Oriani principal investigator
IRCCS OGSA - Site Istituto San Siro
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 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 in people with ASA III and Elective Prosthetic Surgery, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Giorgio Oriani, Physician - Anesthetist (+39335225452, giorgio.oriani@grupposandonato.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 . Two different devices (swab vs sponge) will be compared. (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.