Chloridehexidine Versus Povidine Jodine Both Soluted in Alcohol in Forefoot Surgery

NCT01583192 | Completed Phase 3

• 1 other identifier: mbshadid
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

The study will prospectively compare the efficacy and safety of chloride hexidine soluted in alcohol with povidine-jodine soluted in alcohol in forefoot surgery.

Conditions

Hallux Valgus; Arthritis of the First Metatarsophalangeal Joint

Keywords

infection; skin preparation; fore-foot surgery; chloride-hexidine; povidine-jodine; alcohol

Outcome Measures

Primary Outcomes (2)

• number of positive swab cultures

  During surgery swabs will be taken before skin desinfection, after skin desinfection and at the end of the surgery. We will count the number of positive swab cultures taken from the webspace of their first and second toe and at the place of incision 48 hours post-operatively.

  From start surgery week until 48 hours post-operatively

• wound infection

  we will count the number of wound infections, stated by Prezies, for a period of 6 weeks postoperatively

  until 6 weeks postoperatively

Secondary Outcomes (1)

• Allergic events

  Until 6 weeks postoperatively

Study Arms (2)

chloride-hexidine soluted in alcohol

ACTIVE COMPARATOR

patients will have skin preparation with chloride-hexidine soluted in alcohol prior to their forefoot surgery. Skin swabs will be taken prior to skin preparation, after skin preparation and after skin closure at the end of the operation

Procedure: skin preparation

povidine-jodine soluted in alcohol

ACTIVE COMPARATOR

skin perparation will be done with povidine-jodine soluted in alcohol prior to forefoot surgery.

Procedure: skin preparation

Interventions

skin preparation PROCEDURE

skin preparation while be done either with chloride-hexidine 0,5% soluted in alcohol 70% or povidine-jodine 1% soluted in alcohol 70%

chloride-hexidine soluted in alcohol; povidine-jodine soluted in alcohol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age above 18 years
• written informed consent
• indication for hallux valgus correction or arthrodesis of the first metatarsophalageal joint

You may not qualify if:

• allergic for jodine-povidine and/or chloride-hexidine
• active infection
• skin defect
• blood clotting or coagulation disorder

Sponsors & Collaborators

• St. Antonius Hospital: lead

Study Sites (1)

St Antonius Hospital

Nieuwegein, Utrecht, 340 EM, Netherlands

Location

Related Links

• woundinfection criteria

MeSH Terms

Conditions

Hallux Valgus; Infections

Interventions

Skin Lightening Preparations

Condition Hierarchy (Ancestors)

Foot Deformities; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Cosmetics; Specialty Uses of Chemicals; Chemical Actions and Uses; Household Products; Technology, Industry, and Agriculture

Study Officials

• Mario Speth, MD

  St. Antonius Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 23, 2012
• First Posted: April 23, 2012
• Study Start: March 1, 2013
• Primary Completion: May 1, 2014
• Study Completion: June 1, 2014
• Last Updated: June 9, 2014

Record last verified: 2014-06

Locations

NL (1)