Skin DiseasesPhase 4ribebevaNCT01330706
Efficacy of Intraoperative Surgical Scrubbing in Reducing Bacterial Load After Nail Removal Surgery
A Phase 4 study testing Polihexanide in people with Skin Diseases and Nail Diseases, run by Universidad Complutense de Madrid at 1 site in Spain.
Trial summary
The investigators conducted a controlled, prospective randomized study to examine the antiseptic efficacy of intraoperative irrigation methods during nail avulsion surgery. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Skin Diseases, Nail Diseases, Nails, Ingrown
- What is being tested?
- Polihexanide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- Feb 2010to Mar 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Older than 18
- Onychocryptosis
Who cannot join
- infection
- a history of tinea pedis
- onychomycosis
- paronychia
- nail trauma or subungual hematoma
- nail deformities and disorders
Show all 12Show fewer
- peripheral vascular disease or diabetes
- cardiac disease
- a history of rheumatic fever
- recent antibiotic use or current antimicrobial therapy
- a history of steroid use and
- recent nail polish use
Trial locations and contacts
1 site in 1 country.
About this study
The investigators conducted a controlled, prospective randomized study to examine the antiseptic efficacy of intraoperative irrigation methods during nail avulsion surgery.
Read the detailed description
The investigators conducted a controlled, prospective randomized study to examine the antiseptic efficacy of intraoperative scrubbing methods during nail avulsion surgery. The investigators compared intraoperative antiseptic scrubbing using 0.9% saline solution and 0.1% polihexanide. Swab samples were taken from each patient at 5 distinct stages throughout the surgical procedure, and bacterial culture analysis was performed (positive culture rate, total inocula count, reduction of bacterial load, and identification of specific microorganisms).
- Conditions
- Skin Diseases, Nail Diseases, Nails, Ingrown
- Being tested
- Polihexanide
- Keywords
- Skin Diseases [C17.800], Nail Diseases [C17.800.529], Nails, Ingrown [C17.800.529.406]
- Medical subject headings
- Skin Diseases, Nail Diseases, Nails, Ingrown
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PolihexanideDrug
The investigators compared intraoperative antiseptic irrigation using 0.9% saline solution and 0.1% polihexanide.
| Study group | Role | What they receive |
|---|---|---|
| Sterile Saline solution | Experimental | The investigators compared intraoperative antiseptic irrigation using 0.9% saline solution and 0.1% polihexanide. Receives: Drug: Polihexanide |
What is being measured
The primary outcome is the main question the study is designed to answer.
bacterial count (CFU/cm2)
The percentage of inoculum reduction at the irrigation step was calculated as follows: percentage of inoculum reduction = 100 e (1003 Ii)/Is, where Ii is the bacterial count (CFU/cm2) at the irrigation step and Is is the inoculum (CFU/cm2) at the surgery step.
Bacteria were identified using standard laboratory methods. The limit of detection in the nailfold test was 1.33 CFU/cm2.
Measured: Participants will be followed until the surgery to heal completely,an expected average of 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2011 (estimated)
- Study startFeb 2010
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Skin DiseasesStudies of the same condition, open and under way.
- More trials run by Universidad Complutense de MadridThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Complutense de Madrid
- Sponsor type
- University, hospital or other
- Investigators
- Ricado Becerro de Bengoa Vallejo, PhD, Principal investigator, Universidad Complutense de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01330706
- Sponsor's protocol ID
- UCM 2011
- Acronym
- ribebeva
- Status last verified
- Feb 2009
- First submitted
- 1 Apr 2011
- Last updated
- 7 Apr 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Becerro de Bengoa Vallejo R, Losa Iglesias ME, Cervera LA, Fernandez DS, Prieto JP. Efficacy of intraoperative surgical irrigation with polihexanide and nitrofurazone in reducing bacterial load after nail removal surgery. J Am Acad Dermatol. 2011 Feb;64(2):328-35. doi: 10.1016/j.jaad.2010.01.011. Epub 2010 Nov 26.
PubMed 21112671
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Intraoperative Surgical Scrubbing in Reducing Bacterial Load After Nail Removal Surgery
- ClinicalTrials.gov ID
- NCT01330706
- Acronym / sponsor ID
- ribebeva / UCM 2011
- Conditions
- Skin Diseases, Nail Diseases, Nails, Ingrown
- Keywords
- Skin Diseases [C17.800], Nail Diseases [C17.800.529], Nails, Ingrown [C17.800.529.406]
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Universidad Complutense de MadridUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 7 Apr 2011 (estimated)
- 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.
The investigators conducted a controlled, prospective randomized study to examine the antiseptic efficacy of intraoperative irrigation methods during nail avulsion surgery.
Detailed description
The investigators conducted a controlled, prospective randomized study to examine the antiseptic efficacy of intraoperative scrubbing methods during nail avulsion surgery. The investigators compared intraoperative antiseptic scrubbing using 0.9% saline solution and 0.1% polihexanide. Swab samples were taken from each patient at 5 distinct stages throughout the surgical procedure, and bacterial culture analysis was performed (positive culture rate, total inocula count, reduction of bacterial load, and identification of specific microorganisms).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sterile Saline solution | Experimental | Drug: PolihexanideThe investigators compared intraoperative antiseptic irrigation using 0.9% saline solution and 0.1% polihexanide. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Older than 18
- Onychocryptosis
Key exclusion criteria (12 listed)
- infection
- a history of tinea pedis
- onychomycosis
- paronychia
- nail trauma or subungual hematoma
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 |
|---|---|---|
| PolihexanideThe investigators compared intraoperative antiseptic irrigation using 0.9% saline solution and 0.1% polihexanide. | Drug | Sterile Saline solution |
Primary outcome
bacterial count (CFU/cm2)
Time frame: Participants will be followed until the surgery to heal completely,an expected average of 7 weeks
The percentage of inoculum reduction at the irrigation step was calculated as follows: percentage of inoculum reduction = 100 e (1003 Ii)/Is, where Ii is the bacterial count (CFU/cm2) at the irrigation step and Is is the inoculum (CFU/cm2) at the surgery step. Bacteria were identified using standard laboratory methods. The limit of detection in the nailfold test was 1.33 CFU/cm2.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2011.
- Background: PubMed 21112671Becerro de Bengoa Vallejo R, Losa Iglesias ME, Cervera LA, Fernandez DS, Prieto JP. Efficacy of intraoperative surgical irrigation with polihexanide and nitrofurazone in reducing bacterial load after nail removal surgery. J Am Acad Dermatol. 2011 Feb;64(2):328-35. doi: 10.1016/j.jaad.2010.01.011. Epub 2010 Nov 26.
- University Complutense de MadridLink provided by the sponsor.
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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. This study is not recruiting at the moment.
Ricado Becerro de Bengoa Vallejo, PhD principal investigator
Universidad Complutense de Madrid
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Polihexanide in people with Skin Diseases and Nail Diseases, run by Universidad Complutense de Madrid at 1 site in Spain.
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 2 inclusion and 12 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: finished, as of the sponsor's last update on 7 Apr 2011. 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 Spain. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
bacterial count (CFU/cm2) (time frame: Participants will be followed until the surgery to heal completely,an expected average of 7 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01330706, which also lists 1 linked publication.
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 7 Apr 2011.