No medical condition under investigation, investigation of surgical wound contamination in spinal patients.
Conditions
Interventions
Trade Name: Videne Alcoholic Tincture
Product Name: Povidone Iodine 10%
Pharmaceutical Form: Cutaneous solution
INN or Proposed INN: Povidone Iodine 10%
Sponsors
Belfast Health and Social Care Trust
Queen's University Belfast
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patient is undergoing spinal surgery. 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 0 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: 1) Patients who have had more than 7 days hospitalisation prior to surgery. 2) Patients who have been transferred from another hospital. 3) Patients with overt spinal infections suspected pre-operatively or where evidence of purulence in any part of the wound is observed during surgery. 4) Patients who are sensitive to the skin antiseptics. 5) Patients on antibiotics prior to surgery, other than surgical prophylaxis, as antibiotics can be excreted in sweat and could therefore affect the normal resident skin bacteria.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The rise in antibiotic resistance, typified by MRSA, will inevitably result in an increase in life threatening wound infections after surgery. It is therefore proposed to pre-empt such a scenario by addressing the current procedures used for disinfection of the skin prior to surgery. Povidone-iodine (PVI) and chlorhexidine gluconate (CHG) are antiseptic skin washes with different ways of killing bacteria; however, there have been no clinical trials conducted to determine if CHG used in addition to PVI reduces contamination of wounds with bacteria during surgery. It is therefore proposed to determine if the sequential treatment of patients' skin with PVI and CHG, just before the operation, will reduce wound contamination for patients undergoing orthopaedic surgery.;Secondary Objective: Do the bacteria we isolate from wounds have genes for resistance to antibiotics and antiseptics? Are the bacteria isolated from the wounds the same or different from bacteria on the patient's skin and the skin of theatre staff?;Primary end point(s): To ascertain if the sequential use of povidone-iodine/chlorhexidine gluconate reduces skin wound contamination compared to povidone-iodine use alone. An intermin analysis will be carried out when advised by the Statistican at the CRSC. | — |
Countries
United Kingdom
Outcome results
None listed