Does a longer course of antibiotics reduce the incidence of wound infections after amputation surgery?

Phase 1

• Conditions: Incidence of Surgical Site infection following major lower limb amputation surgery; MedDRA version: 14.1 Level: PT Classification code 10036410 Term: Postoperative wound infection System Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2012-003146-32-GB
• Lead Sponsor: Hull and East Yorkshire Hospital Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-03-14
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 164

Inclusion Criteria

Inclusion Criteria
1. Adults =18 yrs undergoing lower limb amputation
2. Ability to understand the Patient Information Sheet and capable and willing to give
informed consent and follow the protocol requirements (including attending all
follow- up visits)
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 108

Exclusion Criteria

Exclusion criteria;
1.Allergies to chlorhexidine/ alcohol/ iodophors
2.Inability to give informed consent
3.Patients who are admitted to hospital with severe sepsis secondary to gas
gangrene requiring multiple operations and admission to Intensive Care Unit.
4.Aged under 18 years at the time of recruitment
5.Use of investigational drug/device therapy within preceding 4 weeks that may
interfere with this study.
6.Toe amputations

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified