Status
Conditions
Treatments
About
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).
Full description
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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
139 participants in 2 patient groups
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal