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
Conditions
Interventions
Trade Name: HYDREX®, PINK CHLORHEXIDINE GLUCONATE 0.5% W/V IN 70% V/V DEB
Product Name: HYDREX®, PINK CHLORHEXIDINE GLUCONATE 0.5% W/V IN 70% V/V DEB
Pharmaceutical For
Sponsors
Hull and East Yorkshire Hospital Trust
Eligibility
Sex/Gender
All
Inclusion criteria
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: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary objective: to establish if a 5 day course of antibiotics is more clinically and cost effective than a 24 hour prophylactic course in preventing surgical site infection in patients undergoing lower limb amputation.; Secondary Objective: Secondary objectives: •The impact of different skin preparations on infection rates (alcoholic povidone vs alcoholic chlorhexidine) •Rate of re-intervention, and if present, type of re-intervention and level •Mortality •Satisfactory healing rates •Quality of life/utility: SF-12, EQ-5D, McGill Pain score •Mobility (Locomotor Capabilities Index - LCI) •Resource use (including length of stay, number of visits to general practitioners, hospital visits, and prescription of antibiotics). •Rate of C.Diff., MSSA, MRSA infections. ;Primary end point(s): Primary: Occurrence of a surgical site infection. Participants will be asked to complete the Health Protection Agency ‘Patient post discharge questionnaire.’; Timepoint(s) of evaluation of this end point: The questionnaire will be completed at day 7,14, 30 post surgery. On day 14 post surgery participants will undergo clinical review by a clinician blinded to group allocation and the patient post discharge questionnaire completed. Occurrence of a SSI will be defined as positive finding at any of the four follow ups. | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Secondary end points will be measured at baseline, 7, 14, 30 days and months 3 and 12 post surgery.; Secondary end point(s): •The impact of different skin preparations on infection rates (alcoholic povidone vs alcoholic chlorhexidine) •Rate of re-intervention, and if present, type of re-intervention and level •Mortality •Satisfactory healing rates •Quality of life/utility: SF-12, EQ-5D, McGill Pain score •Mobility (Locomotor Capabilities Index - LCI) •Resource use (including length of stay, number of visits to general practitioners, hospital visits, and prescription of antibiotics). •Rate of C.Diff., MSSA, MRSA infections. | — |
Countries
United Kingdom
Outcome results
None listed