None listed
Conditions
Brief summary
Surgical Site Infections (SSI), including infections of the skin, subcutaneous tissue and internal organs, are one of the most common serious complications of surgery and anaesthesia. They are a leading cause of re-admissions and prolonged hospitalisations and they substantially increase the cost of care. Rates of SSI for individual procedures vary widely depending on the population, size of the hospital, type of surgery, experience of the surgeon and methods used for prevention and surveillance. Overall, it is estimated that SSI develops in up to 15 percent of patients undergoing surgical procedures. Endoscopic gynaecologic surgery is a rapidly developing field. Laparoscopic surgery is nowadays used for many procedures that were traditionally performed via laparotomy. Up to date, there are no prospective studies that specifically evaluated the rates of SSI in laparoscopic gynaecologic surgeries or the preferred way of skin preparation to prevent them. Gynaecology units 1 and 2 of The Royal Women's Hospital perform over 700 laparoscopies annually. All patients who undergo planned surgery present to clinic before surgery. We aim to perform a Randomised Controlled Double Blinded Study comparing 3 solutions of skin preparation containing alcohol or aqueous based Povidone-Iodine or Chlorhexidine. Our hypothesis is that Incisional and organ/space SSI rates would be similar throughout all groups. Patients would be followed-up one and four weeks after surgery and SSI rates would be compared amongst groups. SSI would be documented and defined as per the CDC guidelines. We are aiming to examine if we rates of surgical site infections can be reduced by using a specific solution for skin preparation.
Interventions
Intervention: Skin preparation solution prior to gynaecological laparoscopic surgery.
Arm 1: Abdominal preparation with Tinted red Chlorhexidine Gluconate 2% w/v, Ethanol 70% v/v (PharmAust) and Vaginal/Vulvar preparation with Aqueous-based Chlorhexidine Gluconate 2% solution .
Arm 2: Abdominal preparation withiodine Antiseptic Solution- Povidone-Iodine 10% w/v equivalent to 1% w/v available Iodine (Aqueous based, HERRO) solution and Vaginal/Vulvar preparation with Riodine Antiseptic Solution
Intervention: Skin preparation solution prior to gynaecological laparoscopic surgery. Arm 1: Abdominal preparation with Tinted red Chlorhexidine Gluconate 2% w/v, Ethanol 70% v/v (PharmAust) and Vaginal/Vulvar preparation with Aqueous-based Chlorhexidine Gluconate 2% solution . Arm 2: Abdominal preparation withiodine Antiseptic Solution- Povidone-Iodine 10% w/v equivalent to 1% w/v available Iodine (Aqueous based, HERRO) solution and Vaginal/Vulvar preparation with Riodine Antiseptic Solution- Povidone-Iodine 10% w/v equivalent to 1% w/v available Iodine (Aqueous based, HERRO). Arm 3: Abdominal preparation with Alcohol-based Povidone-Iodine 10% solution and Vaginal/Vulvar preparation with Riodine Antiseptic Solution- Povidone-Iodine 10% w/v equivalent to 1% w/v available Iodine (Aqueous based, HERRO). Each of those solutions would be used to clean the skin prior to surgery. This action will be done by one of the surgeons one time prior to surgery.
Sponsors
Dr Uri Dior
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 18 or above * Planned laparoscopy for investigation and treatment of gynaecological disorders * Patient agreement to participate in the study
Exclusion criteria
* History of allergy to chlorhexidine, alcohol, or iodophors * Evidence of infection at or adjacent to the operative site before surgery * The perceived inability to follow the patient’s course for 30 days after surgery. * Emergency laparoscopies. * Patients with known or suspected pelvic inflammatory disease
Outcome results
None listed