NCT02519829

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).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
139

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2010

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

May 28, 2015

Completed
3 months until next milestone

First Posted

Study publicly available on registry

August 11, 2015

Completed
Last Updated

August 11, 2015

Status Verified

August 1, 2015

Enrollment Period

1.5 years

First QC Date

May 28, 2015

Last Update Submit

August 6, 2015

Conditions

Unilateral Primary Osteoarthritis, Unspecified Hip

Keywords

SutureSkin staplesVicrylMonocryl

Outcome Measures

Primary Outcomes (1)

  • Patient Observer Scar Assessment Scale for overall patient satisfaction rates.

    Questionnaire

    3 months

Secondary Outcomes (4)

  • Wound complications

    2 week, 6 week, 3 month post-operatively

  • Drainage rates

    2 week, 6 week, 3 month post-operatively

  • Need for post-operative antibiotics

    2 week, 6 week, 3 month post-operatively

  • Patient pain score

    2 week, 6 week, 3 month post-operatively

Study Arms (2)

Monocryl closure

ACTIVE COMPARATOR

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 closureProcedure: Tegaderm dressing

Vicryl and staple closure

ACTIVE COMPARATOR

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 closureProcedure: Gauze dressing

Interventions

Monocryl closurePROCEDURE

Total Hip Arthroplasty with monocryl closure of wound

Monocryl closure
Vicryl and Staple closurePROCEDURE

Total Hip Arthroplasty with vicryl and staple closure of wound

Vicryl and staple closure
Tegaderm dressingPROCEDURE

Total Hip Arthroplasty with monocryl closure of wound and tegaderm dressing

Monocryl closure
Gauze dressingPROCEDURE

Total Hip Arthroplasty with vicryl and staple closure of wound and gauze dressing

Vicryl and staple closure

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years old
  • Undergoing total hip replacement

You may not qualify if:

  • Previous scar over newly planned incision
  • Alcoholism
  • Mentally unfit to complete questionnaire
  • Connective tissue disease and/or psoriasis/eczema/dermatitis
  • Previous joint infection at surgical site
  • Any use of immunosuppressive medications or disease modifying agents
  • Medical contra-indication to surgery
  • Pregnancy
  • Lack of permanent home address
  • Drug Abuse
  • Allergy to Skin Adhesive

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Polyglactin 910

Intervention Hierarchy (Ancestors)

PolyestersPolymersMacromolecular SubstancesBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • James L Howard, MD

    London Health Sciences Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Orthopedic Surgery

Study Record Dates

First Submitted

May 28, 2015

First Posted

August 11, 2015

Study Start

January 1, 2010

Primary Completion

July 1, 2011

Study Completion

December 1, 2013

Last Updated

August 11, 2015

Record last verified: 2015-08