Total Knee Replacement ClosureNCT01088074
A Comparative Study of Incision Closure Methods for Total Knee Replacement
A study testing Histoacryl Tissue Adhesive, Dermabond and Staples in people with Total Knee Replacement Closure and Wound Closure, run by Foundation for Southwest Orthopedic Research at 1 site in United States.
Trial summary
The aim of the study is to compare incision closure techniques for total knee replacement using a combination of state-of-the-art sutures with tissue adhesives or staples in an effort to identify the best approach with respect to time efficiency, cost, durability, dehiscence, microbial resistance and cosmesis. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Total Knee Replacement Closure, Wound Closure
- What is being tested?
- Histoacryl Tissue Adhesive, Dermabond and Staples
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Oct 2009
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- TKA scheduled without a bilateral planned within one week of the initial surgery
- Willingness to attend prescribed physical therapy 3 times per week.
Who cannot join
- Exclusion criteria included medical conditions or personal circumstances that would prevent participation and completion of physical therapy and follow-up visits
- Current participation in another clinical trial
- Preoperative systemic infections
- Uncontrolled diabetes, or diseases or conditions known to effect the wound healing process
- Known hypersensitivity to cyanoacrylate
- Formaldehyde, or the dye D\&C Violet #2
- Prior knee hardware fixation devices
- Prior knee incisions greater than 9cm, and arthrofibrosis as evidence by limited ROM less than 80°.
Trial locations and contacts
1 site in 1 country.
United States1 site
Foundation for Southwest Orthopedic Research
Houston, Texas, 77030
About this study
Official title: A Comparative Study of Incision Closure Methods for Total Knee Arthroplasty
The aim of the study is to compare incision closure techniques for total knee replacement using a combination of state-of-the-art sutures with tissue adhesives or staples in an effort to identify the best approach with respect to time efficiency, cost, durability, dehiscence, microbial resistance and cosmesis.
The hypothesis is that the combined suture/adhesive approach (sutures for capsule and subcutaneous layers, and tissue adhesive for the final cutaneous layer) or suture/staple approach will be significantly faster and of comparable durability as the conventional exclusive suture approach (sutures used for the capsule, subcutaneous, and cutaneous layers). This is a prospective, randomized, controlled, single site, unblinded (open label) study.
- Conditions
- Total Knee Replacement Closure, Wound Closure
- Being tested
- Histoacryl Tissue Adhesive, Dermabond, Staples, Monocryl 4-0
- Keywords
- Total Knee Replacement, Closure Methods
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Histoacryl Tissue AdhesiveDevice
DermabondDevice
StaplesDevice
Monocryl 4-0Device
| Study group | Role | What they receive |
|---|---|---|
| Histoacryl Tissue Adhesive | Active comparator | Histoacryl Blue (HAB) Tissue Adhesive (n-butyl-2 cyanoacrylate; B. Braun Corp., Melsungen, Germany). Histocryl is a FDA-approved sterile liquid skin adhesive that has been utilized as a substitute for sutures for wound closure for approximately 40 years. Receives: Device: Histoacryl Tissue Adhesive |
| Dermabond | Active comparator | Dermabond High Viscosity Tissue Adhesive (2-ocytl cyanoacrylate; Ethicon, Somerville, NJ). Dermabond is also a FDA-approved liquid bonding agent that has been utilized for wound closure for approximately 10 years and proven as effective as sutures. Receives: Device: Dermabond |
| Staples | Active comparator | Visistat 35W Stapler (Teleflex Corp, Limerick, PA). The FDA-approved Weck staple system with stainless steel staples has been proven over years of use and remains the standard accepted closure approach due to speed of insertion as well as removal. Receives: Device: Staples |
| Running Subcuticular with Monocryl | Active comparator | Monocryl 4-0 Suture (Ethicon, Somerville, NJ). Monocryl is an FDA-approved absorbable, synthetic, suture indicated for soft tissue approximation. Receives: Device: Monocryl 4-0 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome Measure
The primary endpoint is the mean procedure time improvement for TKA incision closure using a combined suture/adhesive or suture/staple approach versus suture closure alone.
Measured: 1/2009-10/2009
Secondary outcomes (1)
Mean postop hospital stay
Change in mean postop hospital stay between study and control cohorts
Measured: 1/2009-10/2009
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2010 (estimated)
- Study startJan 2009
- Primary completionAug 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee Replacement ClosureStudies 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
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Foundation for Southwest Orthopedic Research
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01088074
- Sponsor's protocol ID
- IRB1108-0328
- Status last verified
- Aug 2012
- First submitted
- 16 Mar 2010
- Last updated
- 22 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study of Incision Closure Methods for Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT01088074
- Acronym / sponsor ID
- IRB1108-0328
- Conditions
- Total Knee Replacement Closure, Wound Closure
- Keywords
- Total Knee Replacement, Closure Methods
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Foundation for Southwest Orthopedic ResearchUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Aug 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 17 Mar 2010 (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.
The aim of the study is to compare incision closure techniques for total knee replacement using a combination of state-of-the-art sutures with tissue adhesives or staples in an effort to identify the best approach with respect to time efficiency, cost, durability, dehiscence, microbial resistance and cosmesis.
The hypothesis is that the combined suture/adhesive approach (sutures for capsule and subcutaneous layers, and tissue adhesive for the final cutaneous layer) or suture/staple approach will be significantly faster and of comparable durability as the conventional exclusive suture approach (sutures used for the capsule, subcutaneous, and cutaneous layers). This is a prospective, randomized, controlled, single site, unblinded (open label) study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Histoacryl Tissue Adhesive | Active comparator | Device: Histoacryl Tissue AdhesiveHistoacryl Blue (HAB) Tissue Adhesive (n-butyl-2 cyanoacrylate; B. Braun Corp., Melsungen, Germany). Histocryl is a FDA-approved sterile liquid skin adhesive that has been utilized as a substitute for sutures for wound closure for approximately 40 years. |
| Dermabond | Active comparator | Device: DermabondDermabond High Viscosity Tissue Adhesive (2-ocytl cyanoacrylate; Ethicon, Somerville, NJ). Dermabond is also a FDA-approved liquid bonding agent that has been utilized for wound closure for approximately 10 years and proven as effective as sutures. |
| Staples | Active comparator | Device: StaplesVisistat 35W Stapler (Teleflex Corp, Limerick, PA). The FDA-approved Weck staple system with stainless steel staples has been proven over years of use and remains the standard accepted closure approach due to speed of insertion as well as removal. |
| Running Subcuticular with Monocryl | Active comparator | Device: Monocryl 4-0Monocryl 4-0 Suture (Ethicon, Somerville, NJ). Monocryl is an FDA-approved absorbable, synthetic, suture indicated for soft tissue approximation. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- TKA scheduled without a bilateral planned within one week of the initial surgery
- Willingness to attend prescribed physical therapy 3 times per week.
Key exclusion criteria (8 listed)
- Exclusion criteria included medical conditions or personal circumstances that would prevent participation and completion of physical therapy and follow-up visits
- Current participation in another clinical trial
- Preoperative systemic infections
- Uncontrolled diabetes, or diseases or conditions known to effect the wound healing process
- Known hypersensitivity to cyanoacrylate
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 |
|---|---|---|
| Histoacryl Tissue Adhesive | Device | Histoacryl Tissue Adhesive |
| Dermabond | Device | Dermabond |
| Staples | Device | Staples |
| Monocryl 4-0 | Device | Running Subcuticular with Monocryl |
Primary outcome
Primary Outcome Measure
Time frame: 1/2009-10/2009
The primary endpoint is the mean procedure time improvement for TKA incision closure using a combined suture/adhesive or suture/staple approach versus suture closure alone.
1 secondary outcome
Mean postop hospital stay
Time frame: 1/2009-10/2009
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 22 Aug 2012.
Related trials for Total Knee Replacement Closure
Recruiting
Wound Closure Materials and Techniques in Hip and Knee Arthroplasty
Osteoarthritis, Knee, Osteoarthritis, Hip
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Histoacryl Tissue Adhesive, Dermabond and Staples in people with Total Knee Replacement Closure and Wound Closure, run by Foundation for Southwest Orthopedic Research at 1 site in United States.
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 8 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 22 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Primary Outcome Measure (time frame: 1/2009-10/2009). 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 22 Aug 2012.