Unilateral Primary Osteoarthritis, Unspecified Hip Clinical Trial
Official title:
A Randomized Clinical Trial Comparing Monocryl and Dermabond Closure Versus Staple Closure in Total Hip Arthroplasty
Patients undergoing primary hip arthroplasty will be randomized to receive either monocryl closure of fascial and dermal layers with dermabond and tegaderm covering versus standard vicryl closure of fascia layer and staple closure for skin. Short term wound complications, pain and patient and surgeon-rated cosmetic scar appearance will be measured. The investigators will also measure operating room time and costs associated with dressing changes and wound-related procedures (e.g. staple removal).
Wound closure has always been based on surgeon preference and type of closure. Skin closure
is considered the most important part of the surgical procedure by some since it is often
the only visible evidence of the surgical procedure. In fact, conclusions about the success
of the surgery are often based on the appearance of the wound.
There have been a few studies in a variety of surgical journals that have looked at the two
pertinent methods of closure with the majority coming from obstetrical journals comparing
caesarian section closure with staples versus a subcuticular monocryl suture. For the most
part, although patient satisfaction is quite high initially for a subcuticular closure, at
long term follow-up patient satisfaction scores are quite similar.
One study published in the Journal of Bone and Joint Surgery recommended that staple closure
was more beneficial for skin closure than monocryl sutures for total hip and knee
arthroplasty. Their recommendations were based on an overall shorter operative time when
using staple closure compared to monocryl sutures. They also found that final patient
satisfaction and complication rates were relatively similar 3 months postoperatively. This
group published an earlier paper as well describing the use of glue for closure and did
report an decrease in overall drainage rates when they analyzed their data for subcuticular
sutures as opposed to staples.
A more recent study evaluated wound appearance at 3 months using a surgeon -rated visual
analogue scale to compared the use of adhesive tapes versus staples for skin closure
following total hip arthroplasty. Again, no significant difference in patient satisfaction
scores were reported.
To date, there is a paucity of well-powered studies to compare outcomes in patients whose
wounds are closed using the usual staple methods compared to a monocryl suture method. In
addition, outcomes have focused on surgeon-ratings and not patient ratings. The proposal for
this study is to compare overall patient and surgeon-rated cosmetic scar appearance and
complications following total hip replacement with skin closure for using monocryl suture
versus staples. This study would use a more recent, validated assessment tool than the VAS
scale. The assessment is called the Patient Observer Scar Assessment Scale (POSAS ) and it
incorporates six essential features about the wound such as colour, malleability, etc. The
form is split so that the surgeon rating carries the same weight in the final score as the
patient assessment of their own scar. This scale gives a nice balance for determining
overall satisfaction and wound healing combining surgeon and patient scores.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment