None listed
Conditions
Brief summary
The proposed pilot trial will be the first of its kind in the world with an aim to assess the role of using an antimicrobial sealant in reducing the incidence of surgical site infection following elective caesarean section. We believe this study will assist in planning and implementation of methods to minimise post operative complications, maximise recovery after surgery, and increase patient satisfaction. By participating in the study you will be allocated randomly to either a treatment group or a control group on the day of your operation. Participants allocated in the treatment group will have an antimicrobial sealant and antibacterial skin preparation applied to their abdomen before the caesarean section begins. Participants in the control group will receive only antibacterial skin preparation (routine surgical care) prior to their caesarean section. Although at this point you will have an epidural/spinal anaesthetic, the application of the antimicrobial sealant is not painful. Following your procedure, we will care for you as we usually would following a caesarean section. We will record any evidence of surgical site infection whilst you are an inpatient. Once you are discharged from hospital, we will continue to check in with you on Day 7-10 and day 28-30 post operatively to assess for the development of infection. We will contact you through a videoconference call so we can both talk to you and review your wound visually. We will also ask you to take a picture of your caesarean wound at these video conference reviews which we will keep to assess for infection. There will be no identifying features on these photos, so you don’t need to worry about being identified from the photo. All photographs will be deleted following the mandatory period in which they are required to be stored. We will also assess your recovery activity using another visual scoring system, which will be provided to you on you discharge from hospital. We will use the collated information to determine whether using an antimicrobial sealant reduces the likelihood of developing a surgical site infection after a Caesarean section, compared to current standard practice. We will also look at the rate of readmission to hospital with infection following the operation, rate of skin irritation, rate of antibiotic prescription and overall recovery following the Caesarean section between the two groups
Interventions
Application of Antimicrobial sealant (Floraseal (Registered) Adhezion Biomedical) to surgical site following skin preparation with 2% chlorhexidine gluconate/70% Isopropyl alcohol prior to draping and skin incision for Caesarean section. The antimicrobial sealant will be applied once only in the operating theatre prior to draping and skin incision. The sealant will cover the intended surgical site and an additional 4-5 centimetres surrounding this. The sealant will be left to dry until the skin
Application of Antimicrobial sealant (Floraseal (Registered) Adhezion Biomedical) to surgical site following skin preparation with 2% chlorhexidine gluconate/70% Isopropyl alcohol prior to draping and skin incision for Caesarean section. The antimicrobial sealant will be applied once only in the operating theatre prior to draping and skin incision. The sealant will cover the intended surgical site and an additional 4-5 centimetres surrounding this. The sealant will be left to dry until the skin in no longer tacky, as per manufacturers instructions. A case report form will be completed by surgeons following the operation detailing notable variables including BMI, measured blood loss and operative time. Participants will be provided information resources produced by the product developer regarding the nature of the antimicrobial sealant prior to consenting to participate in the study and throughout the study process. The Antimicrobial sealant will be applied by the surgeon across the intended surgical field using the device applicator. The surgeon will be trained in the correct application by viewing instructional videos created by the produce developer as seen here https://vimeo.com/417865438
Sponsors
Dr Samuel Cresser
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
• Age between 18-50 • Undergoing elective Caesarean section • Able to consent to participate • English Speaking • >37 completed weeks gestation
Exclusion criteria
• Unable to consent • Midline laparotomy at caesarean section • History of allergy to antimicrobial sealants/cyanoacrylate • Evidence of infection at or adjacent to the surgical site • Undergoing emergency Caesarean Section • Chorioamnionitis; suspected or confirmed
Outcome results
None listed