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

Sponsor

Universidad Complutense de Madrid (Other)

Overall Status

Completed

CT.gov ID

NCT01330706

Collaborator

(none)

Enrollment

Location

Arm

12.9

Duration (Months)

3.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Skin Diseases Nail Diseases Nails, Ingrown	Drug: Polihexanide	Phase 4

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

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Feb 1, 2010

Actual Primary Completion Date :

Mar 1, 2011

Actual Study Completion Date :

Mar 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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.

Outcome Measures

Primary Outcome Measures

bacterial count (CFU/cm2) [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.