Clinical trial NCT02519829: A Clinical Trial Comparing Monocryl and Dermabond Closure Versus Staple Closure in Total Hip Arthroplasty
Official title: A Randomized Clinical Trial Comparing Monocryl and Dermabond Closure Versus Staple Closure in Total Hip Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Unilateral Primary Osteoarthritis, Unspecified Hip
Keywords: Suture
Skin staples
Vicryl
Monocryl
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2015-08-11
Enrollment: 139
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).

Detailed 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.

Eligibility criteria: Inclusion Criteria:

1. 18 - 100 years old
2. Undergoing total hip replacement

Exclusion Criteria:

1. Previous scar over newly planned incision
2. Alcoholism
3. Mentally unfit to complete questionnaire
4. Connective tissue disease and/or psoriasis/eczema/dermatitis
5. Previous joint infection at surgical site
6. Any use of immunosuppressive medications or disease modifying agents
7. Medical contra-indication to surgery
8. Pregnancy
9. Lack of permanent home address
10. Drug Abuse
11. Allergy to Skin Adhesive

Primary outcomes:
measure: Patient Observer Scar Assessment Scale for overall patient satisfaction rates.
timeFrame: 3 months
Secondary outcomes:
measure: Wound complications
timeFrame: 2 week, 6 week, 3 month post-operatively
measure: Drainage rates
timeFrame: 2 week, 6 week, 3 month post-operatively
measure: Need for post-operative antibiotics
timeFrame: 2 week, 6 week, 3 month post-operatively
measure: Patient pain score
timeFrame: 2 week, 6 week, 3 month post-operatively
Other outcomes:
Locations:
Study officials:
affiliation: London Health Sciences Centre
name: James L Howard, MD
role: PRINCIPAL_INVESTIGATOR
References: