None listed
Conditions
Brief summary
The NEWStitch trial is a cluster randomised controlled pilot study comparing Triclosan-coated sutures with non-coated sutures in adult surgical patients. Conducted across four NSW hospitals, the study uses 8-week cluster blocks to simplify implementation and maintain protocol adherence in high-volume operating settings. The primary aim is to assess feasibility for a larger trial, including recruitment rates, data capture, and adherence to randomisation. Secondary outcomes include surgical site infection rates, wound healing (Bluebelle PROM), cost-effectiveness, adverse skin reactions, complications, and readmissions. This independent, non-industry-funded study responds to growing concern about the routine use of Triclosan sutures without sufficient evidence on safety, effectiveness, or cost.
Interventions
• Participants will receive either Triclosan-coated (Arm A) or non-coated (Arm B) sutures. Sutures used for this intervention are for closing superficial fascia only. The cluster randomisation is based on the 8-week time period in which their surgery occurs. Randomisation is by cluster, with each cluster representing an 8-week block (4 clusters per arm). No washout period is needed, as suture types will be swapped using dedicated trolleys.
• At 30-day post-surgery, participants will be emailed t
• Participants will receive either Triclosan-coated (Arm A) or non-coated (Arm B) sutures. Sutures used for this intervention are for closing superficial fascia only. The cluster randomisation is based on the 8-week time period in which their surgery occurs. Randomisation is by cluster, with each cluster representing an 8-week block (4 clusters per arm). No washout period is needed, as suture types will be swapped using dedicated trolleys. • At 30-day post-surgery, participants will be emailed the Bluebelle wound healing questionnaire. A score of 4 will indicate possible wound infection. Non-responders with a mobile number will receive up to two reminder texts; those without will be called (maximum two attempts) between days 31–37. • A sub-group receiving implants will be sent a follow-up survey at 90 days for surgical site infection (SSI) surveillance.
Sponsors
Hunter New England Local Health District
Study design
Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patient undergoing surgery with surgery defined as any operation performed within a sterile operating theatre requiring wound closure. 18 years and over
Exclusion criteria
Have contraindications to Triclosan (previous allergy or adverse reactions
Outcome results
None listed