A Clinical Trial Comparing Monocryl and Dermabond Closure Versus Staple Closure in Total Hip Arthroplasty
|ClinicalTrials.gov Identifier: NCT02519829|
Recruitment Status : Completed
First Posted : August 11, 2015
Last Update Posted : August 11, 2015
|Condition or disease||Intervention/treatment||Phase|
|Unilateral Primary Osteoarthritis, Unspecified Hip||Procedure: Monocryl closure Procedure: Vicryl and Staple closure Procedure: Tegaderm dressing Procedure: Gauze dressing||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||139 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Clinical Trial Comparing Monocryl and Dermabond Closure Versus Staple Closure in Total Hip Arthroplasty|
|Study Start Date :||January 2010|
|Actual Primary Completion Date :||July 2011|
|Actual Study Completion Date :||December 2013|
Active Comparator: Monocryl closure
The skin incision is closed with monocryl dissolvable sutures and a topical adhesive (glue) called Dermabond and covered with a Tegaderm dressing.
Intervention: Monocryl closure, Tegaderm dressing
Procedure: Monocryl closure
Total Hip Arthroplasty with monocryl closure of wound
Procedure: Tegaderm dressing
Total Hip Arthroplasty with monocryl closure of wound and tegaderm dressing
Active Comparator: Vicryl and staple closure
The skin incision is closed with vicryl and staples and covered with a gauze dressing.
Intervention: Vicryl and Staple closure, Gauze dressing
Procedure: Vicryl and Staple closure
Total Hip Arthroplasty with vicryl and staple closure of wound
Procedure: Gauze dressing
Total Hip Arthroplasty with vicryl and staple closure of wound and gauze dressing
- Patient Observer Scar Assessment Scale for overall patient satisfaction rates. [ Time Frame: 3 months ]Questionnaire
- Wound complications [ Time Frame: 2 week, 6 week, 3 month post-operatively ]Analysis - number of participants with wound complications
- Drainage rates [ Time Frame: 2 week, 6 week, 3 month post-operatively ]Analysis - number of participants with wound drainage
- Need for post-operative antibiotics [ Time Frame: 2 week, 6 week, 3 month post-operatively ]Analysis - number of participants with need for post-operative antibiotics
- Patient pain score [ Time Frame: 2 week, 6 week, 3 month post-operatively ]Questionnaire
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02519829
|Principal Investigator:||James L Howard, MD||London Health Sciences Centre|