Unilateral Primary Osteoarthritis, Unspecified HipNCT02519829
A Clinical Trial Comparing Monocryl and Dermabond Closure Versus Staple Closure in Total Hip Arthroplasty
A study testing Monocryl closure, Vicryl and Staple closure and Tegaderm dressing in people with Unilateral Primary Osteoarthritis, Unspecified Hip, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Unilateral Primary Osteoarthritis, Unspecified Hip
- What is being tested?
- Monocryl closure, Vicryl and Staple closure and Tegaderm dressing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 139 participants
- Where
- No sites listed yet
- Study dates
- Jan 2010to Dec 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 - 100 years old
- Undergoing total hip replacement
Who cannot join
- 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
Show all 11Show fewer
- Medical contra-indication to surgery
- Pregnancy
- Lack of permanent home address
- Drug Abuse
- Allergy to Skin Adhesive
About this study
Official title: A Randomized Clinical Trial Comparing Monocryl and Dermabond Closure Versus Staple Closure in Total Hip Arthroplasty
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).
Read the 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.
- Being tested
- Monocryl closure, Vicryl and Staple closure, Tegaderm dressing, Gauze dressing
- Keywords
- Suture, Skin staples, Vicryl, Monocryl
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monocryl closureProcedure or surgery
Total Hip Arthroplasty with monocryl closure of wound
Vicryl and Staple closureProcedure or surgery
Total Hip Arthroplasty with vicryl and staple closure of wound
Tegaderm dressingProcedure or surgery
Total Hip Arthroplasty with monocryl closure of wound and tegaderm dressing
Gauze dressingProcedure or surgery
Total Hip Arthroplasty with vicryl and staple closure of wound and gauze dressing
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Monocryl closure; Procedure: 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 Receives: Procedure: Vicryl and Staple closure; Procedure: Gauze dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Observer Scar Assessment Scale for overall patient satisfaction rates.
Questionnaire
Measured: 3 months
Secondary outcomes (4)
Wound complications
Analysis - number of participants with wound complications
Measured: 2 week, 6 week, 3 month post-operatively
Drainage rates
Analysis - number of participants with wound drainage
Measured: 2 week, 6 week, 3 month post-operatively
Need for post-operative antibiotics
Analysis - number of participants with need for post-operative antibiotics
Measured: 2 week, 6 week, 3 month post-operatively
Patient pain score
Questionnaire
Measured: 2 week, 6 week, 3 month post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2015 (estimated)
- Study startJan 2010
- Primary completionJul 2011
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unilateral Primary Osteoarthritis, Unspecified HipStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 139 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James Howard, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Investigators
- James L Howard, MD, Principal investigator, London Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02519829
- Sponsor's protocol ID
- 6757 (REB # 16747)
- Status last verified
- Aug 2015
- First submitted
- 28 May 2015
- Last updated
- 11 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial Comparing Monocryl and Dermabond Closure Versus Staple Closure in Total Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT02519829
- Acronym / sponsor ID
- 6757 (REB # 16747)
- Keywords
- Suture, Skin staples, Vicryl, Monocryl
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 139 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Jul 2011 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 11 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Monocryl closure | Active comparator | Procedure: Monocryl closure, Procedure: Tegaderm dressingThe 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 |
| Vicryl and staple closure | Active comparator | Procedure: Vicryl and Staple closure, Procedure: Gauze dressingThe skin incision is closed with vicryl and staples and covered with a gauze dressing. Intervention: Vicryl and Staple closure, Gauze dressing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 - 100 years old
- Undergoing total hip replacement
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Monocryl closureTotal Hip Arthroplasty with monocryl closure of wound | Procedure or surgery | Monocryl closure |
| Vicryl and Staple closureTotal Hip Arthroplasty with vicryl and staple closure of wound | Procedure or surgery | Vicryl and staple closure |
| Tegaderm dressingTotal Hip Arthroplasty with monocryl closure of wound and tegaderm dressing | Procedure or surgery | Monocryl closure |
| Gauze dressingTotal Hip Arthroplasty with vicryl and staple closure of wound and gauze dressing | Procedure or surgery | Vicryl and staple closure |
Primary outcome
Patient Observer Scar Assessment Scale for overall patient satisfaction rates.
Time frame: 3 months
Questionnaire
4 secondary outcomes
Wound complications
Time frame: 2 week, 6 week, 3 month post-operatively
Drainage rates
Time frame: 2 week, 6 week, 3 month post-operatively
Need for post-operative antibiotics
Time frame: 2 week, 6 week, 3 month post-operatively
Patient pain score
Time frame: 2 week, 6 week, 3 month post-operatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2015.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James L Howard, MD principal investigator
London Health Sciences Centre
Questions about this trial
What is this clinical trial studying?
A study testing Monocryl closure, Vicryl and Staple closure and Tegaderm dressing in people with Unilateral Primary Osteoarthritis, Unspecified Hip, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Observer Scar Assessment Scale for overall patient satisfaction rates. (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2015; AzTrials last refreshed its copy on 31 Oct 2026.