Incidence of Surgical Site infection following clean or clean-contaminated, non-implant, vascular surgery MedDRA version: 16.1 Level: PT Classification code 10036410 Term: Postoperative wound infection System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: VIDENE ALCOHOLIC TINCTURE
Product Name: VIDENE ALCOHOLIC TINCTURE
Product Code: Marketing authorisation number PL 04509/0040
Pharmaceutical Form: Cutaneous solution
INN or Proposed INN: P
Sponsors
Hull and East Yorkshire Hospital Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion Criteria a. Adults =18 yrs undergoing clean/ clean-contaminated non-implant vascular surgery. b. 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 650 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 220
Exclusion criteria
Exclusion criteria: Exclusion criteria; a. Patients on antibiotics for other conditions at the time of surgery or in the follow up period. b. Allergies to chlorhexidine/ alcohol/ iodophors c. Inability to give informed consent d. Aged under 18 years at time of recruitment e. Use of investigational drug/device therapy within preceding 4 weeks that may interfere with this study Withdrawal criteria; a)Patient request b)Patient non compliance with study protocol c)Patient suffers an adverse event/ reaction such that they cannot continue d)Patient dies
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary Objective: to assess the clinical and cost effectiveness of pre-operative skin cleansing with chlorhexidine and povidone-iodine in preventing surgical site infection and establish the impact of aqueous versus alcoholic solutions, in patients undergoing clean or clean-contaminated, non-implant vascular surgery.;Secondary Objective: When compared to Povidone-iodine does Chlorhexidine: a. Increase the number of wounds which heal satisfactorally? b. Improve patient quality of life post-operatively? c. Reduced the length of time to return to work/ normal activities after surgery? d. Reduce patient resource use? e. Reduce the cost to the NHS? f. Reduce patient mortality?;Primary end point(s): Primary: Occurrence of Surgical site infection. Participants will be asked to complete the Health Protection Agency ‘Patient post-discharge questionnaire’ and attend for clinical review. ;Timepoint(s) of evaluation of this end point: The questionnaire will be completed at day 5-7 and day 30 post-surgery. On day 5-7 and day 30 post-surgery participants will undergo clinical review by a clinician blinded to group allocation and the patient post-discharge questionnaire will be completed on day 30. Occurrence of a surgical site infection will be defined as positive finding at any of the described follow ups. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Satisfactory healing; Quality of life/utility: SF-36 and EQ-5D and Resource use (including number of visits to general practitioners, hospital visits, and prescription of antibiotics). ;Timepoint(s) of evaluation of this end point: All secondary end points will be measured at baseline, days 5-7, and day 30 post-surgery. | — |
Countries
United Kingdom
Outcome results
None listed