A Clinical Trial Comparing Monocryl and Dermabond Closure Versus Staple Closure in Total Hip Arthroplasty

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02519829
• Other study ID #: 6757 (REB # 16747)
• Status: Completed
• Phase: N/A
• First received: May 28, 2015
• Last updated: August 6, 2015
• Start date: January 2010
• Est. completion date: December 2013

Study information

• Verified date: August 2015
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review CommitteeCanada: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 139
• Est. completion date: December 2013
• Est. primary completion date: July 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis
• Unilateral Primary Osteoarthritis, Unspecified Hip

Intervention

Procedure:
• Monocryl closure
Total Hip Arthroplasty with monocryl closure of wound
• Vicryl and Staple closure
Total Hip Arthroplasty with vicryl and staple closure of wound
• Tegaderm dressing
Total Hip Arthroplasty with monocryl closure of wound and tegaderm dressing
• Gauze dressing
Total Hip Arthroplasty with vicryl and staple closure of wound and gauze dressing

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Lawson Health Research Institute

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Observer Scar Assessment Scale for overall patient satisfaction rates.	Questionnaire	3 months	No
Secondary	Wound complications	Analysis - number of participants with wound complications	2 week, 6 week, 3 month post-operatively	No
Secondary	Drainage rates	Analysis - number of participants with wound drainage	2 week, 6 week, 3 month post-operatively	No
Secondary	Need for post-operative antibiotics	Analysis - number of participants with need for post-operative antibiotics	2 week, 6 week, 3 month post-operatively	No
Secondary	Patient pain score	Questionnaire	2 week, 6 week, 3 month post-operatively	No