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

Universidad Complutense de Madrid

Status and phase: Completed; Phase 4

Conditions: Nails, Ingrown; Skin Diseases; Nail Diseases

Treatments: Drug: Polihexanide

Study type: Interventional

Funder types: Other

Identifiers

NCT01330706

UCM 2011

Details and patient eligibility

About

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

Full 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).

Enrollment: 50 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Sterile Saline solution

Experimental group

Description:

The investigators compared intraoperative antiseptic irrigation using 0.9% saline solution and 0.1% polihexanide.

Treatment:

Drug: Polihexanide