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

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ClinicalTrials.gov Identifier: NCT02519829
Recruitment Status : Completed
First Posted : August 11, 2015
Last Update Posted : August 11, 2015
Sponsor:
Information provided by (Responsible Party):
James Howard, Lawson Health Research Institute

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).

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

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 139 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Patient Observer Scar Assessment Scale for overall patient satisfaction rates. [ Time Frame: 3 months ]
    Questionnaire


Secondary Outcome Measures :
  1. Wound complications [ Time Frame: 2 week, 6 week, 3 month post-operatively ]
    Analysis - number of participants with wound complications

  2. Drainage rates [ Time Frame: 2 week, 6 week, 3 month post-operatively ]
    Analysis - number of participants with wound drainage

  3. 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

  4. Patient pain score [ Time Frame: 2 week, 6 week, 3 month post-operatively ]
    Questionnaire



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02519829


Sponsors and Collaborators
Lawson Health Research Institute
Investigators
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Principal Investigator: James L Howard, MD London Health Sciences Centre
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Responsible Party: James Howard, Assistant Professor, Orthopedic Surgery, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT02519829    
Other Study ID Numbers: 6757 (REB # 16747)
First Posted: August 11, 2015    Key Record Dates
Last Update Posted: August 11, 2015
Last Verified: August 2015
Keywords provided by James Howard, Lawson Health Research Institute:
Suture
Skin staples
Vicryl
Monocryl
Additional relevant MeSH terms:
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Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases