None listed
Conditions
Brief summary
Postoperative infections are the most common cause of complications in surgical patients and result in an average increase of four days in the hospital. Foot and ankle surgery may have a higher infection rate than other surgical areas since surgical preparation cannot fully reduce the bacterial load prior to incision. Due to the increased rate of infection and wound breakdown surgeons routinely reinforce absorbable subcuticular wound closures with non-absorbable skin sutures. Removal of these sutures can be painful and leave unsightly scars. 2- Octyl-cyanoacrylate tissue adhesive is available in Australia as an alternative to skin suturing for wound closure. There have been mixed results with this product with some studies showing good wound closure and low infection rates and others showing high rates of wound dehiscence and infection. The high rates of wound dehiscence with tissue adhesive has been postulated to be due to high wound tension. We believe that tissue adhesive may be successful an occlusive reinforcement after proper skin closure with appropriate methods to reduce tension such as subcuticular stitching. There have been no studies looking at using tissue adhesive in this fashion in foot and ankle surgery. The hypothesis of this study is that using tissue adhesive rather than non absorbable sutures to reinforce forefoot wounds will reduce patient pain and anxiety at dressing change whilst not affecting the quality of wound healing. The study will be powered to assess these two parameters.
Interventions
Intervention: skin closure reinforcement with 2- Octyl-cyanoacrylate tissue adhesive following subcuticular skin closure with absorbable 3.0 vicryl rapide following elective open forefoot surgery (either hallux valgus correction or first MTP arthrodesis). All wound closure (in either group) was conducted by a single surgeon (the Principal Investigator, an orthopaedic foot and ankle surgeon). Study data including intervention type was entered into a study-specific database following the intervent
Intervention: skin closure reinforcement with 2- Octyl-cyanoacrylate tissue adhesive following subcuticular skin closure with absorbable 3.0 vicryl rapide following elective open forefoot surgery (either hallux valgus correction or first MTP arthrodesis). All wound closure (in either group) was conducted by a single surgeon (the Principal Investigator, an orthopaedic foot and ankle surgeon). Study data including intervention type was entered into a study-specific database following the intervention. Adherence was confirmed at the pre-specified follow up times.
Sponsors
St Vincent's Hospital Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
The inclusion criteria for this study were: - Age greater than 18 years - Undergoing elective open forefoot surgery; either Scarf ± Akin osteotomy for hallux valgus or first metatarsophalangeal joint arthrodesis) - Informed consent for participation in the RCT
Exclusion criteria
The exclusion criteria for this study were: - Revision forefoot surgery - Percutaneous forefoot surgery - Patients undergoing surgery not involving the first ray - Cognitive impairment preventing patient from adhering to post operative instructions or completing patient reported outcome scores
Outcome results
None listed