None listed
Conditions
Brief summary
This is a randomised controlled trial of 40 consecutive patients undergoing elective total hip arthroplasty. The aim is evaluate the use of a tissue adhesive (Glubran 2, Matrix Surgical) for subcutaneous fat closure. Participants will be randomised to have their fat layer closed with either a tissue adhesive or dissolvable sutures. The participants will undergo an ultrasound at day 10 to 20 post-operatively to assess the degree of fluid accumulation in the fat layer. Outcomes will include the incidence and magnitude of superficial seroma, participant reported pain scores, blood loss and incidence of wound complications. We hypothesise that subcutaneous fat closed with the glue will have less fluid accumulation which may be a precursor to infection.
Interventions
This is a two-armed study comparing methods of fat layer closure during hip replacement. Participants enrolled in the trial will be randomised to have their fat layer closed with either Glubran 2 surgical adhesive or 1 Vicryl sutures.
Both interventions will be performed by the operative orthopaedic surgeon who has 10 years' experience.
The one intervention will be performed per participant in the operating theatres at Linacre Private Hospital.
Arm 1:
Intervention - Glubran 2 surgical adhesiv
This is a two-armed study comparing methods of fat layer closure during hip replacement. Participants enrolled in the trial will be randomised to have their fat layer closed with either Glubran 2 surgical adhesive or 1 Vicryl sutures. Both interventions will be performed by the operative orthopaedic surgeon who has 10 years' experience. The one intervention will be performed per participant in the operating theatres at Linacre Private Hospital. Arm 1: Intervention - Glubran 2 surgical adhesive Description - This is a synthetic cyanoacrylate glue that is biodegradable, TGA approved for use on internal tissues. It is manufactured by GEM in Italy and distributed by Matrix Surgical in Australia. Procedure - During closure of the subcutaneous fat layer, 1mL of Glubran 2 will be evenly applied to the fat layer and deep fascia, deep to the dermal tissue using a spray applicator. The wound edges will be approximated for 90 seconds to allow the tissue adhesive to work. The dermal and epidermal layers will be everted to ensure they are not glued. Arm 2: Intervention - 1 Vicryl sutures Description - This is a biodegradable polyglactin suture, TGA approved for tissue approximation. It is manufactured and distributed by Ethicon. Procedure - During closure of the subcutaneous fat layer, the subcutaneous fat will be closed using interrupted 1 vicryl sutures spread approximately 3cm apart spanning the length of the wound. Sutures will be tensioned appropriately to oppose the layer while avoiding damage to the tissue and subsequent fat necrosis. For both interventional arms: The dermal and subcuticular layers will be closed with running dissolvable 2.0 vicryl and 3.0 stratafix sutures respectively. Tiss2 tissue adhesive (Matrix Surgical; GEM, Italy) will be applied to the wound and allowed to dry prior to application of a waterproof dressing.
Sponsors
Edward O'Bryan
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
All patients planned for total hip arthroplasty by a single surgeon (Chris Jones) at the institution will be eligible for the study. (Linacre Private Hospital)
Exclusion criteria
Previous surgery on the affected hip Contraindication to tissue adhesive use Wounds that cannot be primarily closed or require a negative pressure dressing
Outcome results
None listed