None listed
Conditions
Brief summary
While cyanoacrylates and steri-strips reduce operative time and drainage, they risk contact dermatitis, detachment, and suboptimal cosmesis in 5-30% of cases. Silk fibroin may address these with biocompatibility and mechanical stability, showing consistent superiority in total joint arthroplasty cohorts, but evidence is largely retrospective or from non-total knee arthroplasty sites. No head-to-head RCTs compare silk fibroin directly to Histoacryl and Steri-Strips in total knee arthroplasty (TKA), where knee-specific stresses (flexion, edema) amplify risks. A prospective RCT could evaluate primary outcomes of surgical site infection, wound complications, cosmesis and patient satisfaction, filling this gap and informing standardized protocols amid rising total knee arthroplasty volumes.
Interventions
Non-Immunogenic Silk Fibroin Mesh Skin Closure Dressing (SYLKE®) is a 99.9% purified silk fibroin woven mesh with pressure-sensitive acrylic adhesive, designed for biocompatible, breathable closure that permits exudate drainage and oxygen exchange. Unlike synthetic adhesives, silk fibroin is non-immunogenic, non-cytotoxic, and hypoallergenic. This dressing will be applied over the surgical incision with an adhesive opsite dressing placed over the top which will remain for 2 weeks. This will be p
Non-Immunogenic Silk Fibroin Mesh Skin Closure Dressing (SYLKE®) is a 99.9% purified silk fibroin woven mesh with pressure-sensitive acrylic adhesive, designed for biocompatible, breathable closure that permits exudate drainage and oxygen exchange. Unlike synthetic adhesives, silk fibroin is non-immunogenic, non-cytotoxic, and hypoallergenic. This dressing will be applied over the surgical incision with an adhesive opsite dressing placed over the top which will remain for 2 weeks. This will be performed at teh completion of surgery of the operative surgeons. The dressing should only be applied once, and will be only changed if there is prolonged wound ooze or concerns for wound healing which will occur by a registered nurse. As an inpatient dressing changes will be documented. Any concerns as an outpatient will be identified with phone follow-up.
Sponsors
Whangarei Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
• Age 40 – 80 • Primary TKA • Performed with a medial parapatellar approach • Performed for a diagnosis of osteoarthritis • Unilateral procedure • Wound closure with absorbable 3.0 subcuticular
Exclusion criteria
• • Post-traumatic arthritis • Performed with a lateral parapatellar approach • Previous history of septic arthritis or osteomyelitis around the knee • Revision TKA • Bilateral procedure • Unicompartmental knee replacement • Previous surgical incisions at the knee other than arthroscopy • Allergy to histoacryl • Inability to consent • Wound closure with staples • Patients unable for the required follow-up of 12 weeks • Non-English-speaking subjects (post-operative data collection procedure involves phone conversations. As we do not have access to translators for this research project, we will work exclusively with English-speaking subjects
Outcome results
None listed