Efficacy of Intraoperative Surgical Scrubbing in Reducing Bacterial Load After Nail Removal Surgery (ribebeva)
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Purpose
The investigators conducted a controlled, prospective randomized study to examine the antiseptic efficacy of intraoperative irrigation methods during nail avulsion surgery.
| Condition | Intervention | Phase |
|---|---|---|
|
Skin Diseases Nail Diseases Nails, Ingrown |
Drug: Polihexanide |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Efficacy of Intraoperative Surgical Scrubbing in Reducing Bacterial Load After Nail Removal Surgery |
- bacterial count (CFU/cm2) [ Time Frame: Participants will be followed until the surgery to heal completely,an expected average of 7 weeks ] [ Designated as safety issue: No ]
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.
| Enrollment: | 50 |
| Study Start Date: | February 2010 |
| Study Completion Date: | March 2011 |
| Primary Completion Date: | March 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Sterile Saline solution
The investigators compared intraoperative antiseptic irrigation using 0.9% saline solution and 0.1% polihexanide.
|
Drug: Polihexanide
The investigators compared intraoperative antiseptic irrigation using 0.9% saline solution and 0.1% polihexanide.
|
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).
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Older than 18
- Onychocryptosis
Exclusion Criteria:
- infection
- a history of tinea pedis
- onychomycosis
- paronychia
- nail trauma or subungual hematoma
- nail deformities and disorders
- 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
Contacts and Locations| Spain | |
| Universidad Complutense de Madrid | |
| Madrid, Spain, 28040 | |
| Principal Investigator: | Ricado Becerro de Bengoa Vallejo, PhD | Complutense University of Madrid |
More Information
Additional Information:
Publications:
| Responsible Party: | Ricardo Becerro de Bengoa Vallejo, Universidad Complutense de Madrid |
| ClinicalTrials.gov Identifier: | NCT01330706 History of Changes |
| Other Study ID Numbers: | UCM 2011 |
| Study First Received: | April 1, 2011 |
| Last Updated: | April 6, 2011 |
| Health Authority: | Spain: Complutense University of Madrid |
Keywords provided by Universidad Complutense de Madrid:
|
Skin Diseases [C17.800] Nail Diseases [C17.800.529] Nails, Ingrown [C17.800.529.406] |
Additional relevant MeSH terms:
|
Nail Diseases Nails, Ingrown Skin Diseases |
ClinicalTrials.gov processed this record on May 16, 2013