Efficacy of Intraoperative Surgical Scrubbing in Reducing Bacterial Load After Nail Removal Surgery

Skin Diseases Clinical Trial

— ribebeva  

Official title:

Efficacy of Intraoperative Surgical Scrubbing in Reducing Bacterial Load After Nail Removal Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01330706
• Other study ID #: UCM 2011
• Status: Completed
• Phase: Phase 4
• First received: April 1, 2011
• Last updated: April 6, 2011
• Start date: February 2010
• Est. completion date: March 2011

Study information

• Verified date: February 2009
• Source: Universidad Complutense de Madrid
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The investigators conducted a controlled, prospective randomized study to examine the antiseptic efficacy of intraoperative irrigation methods during nail avulsion surgery.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Nail Diseases
• Nails, Ingrown
• Skin Diseases

Intervention

Drug:
• Polihexanide
The investigators compared intraoperative antiseptic irrigation using 0.9% saline solution and 0.1% polihexanide.

Locations

Country	Name	City	State
Spain	Universidad Complutense de Madrid	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Complutense de Madrid

Country where clinical trial is conducted

Spain, 

References & Publications (1)

Becerro de Bengoa Vallejo R, Losa Iglesias ME, Cervera LA, Fernández 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Participants will be followed until the surgery to heal completely,an expected average of 7 weeks

External Links

•   University Complutense de Madrid