ErythemaNCT00940446
A Comparison of INSORB Staples With Metal Staples in Total Hip Replacement
A study testing Insorb staples and metal staples (Ethicon metal stapler) in people with Erythema and Drainage, run by Orthopaedic Research Foundation at 1 site in United States.
Trial summary
The purpose of this study is to compare the use of INSORB absorbable staples with metal staples on surgical incision healing after total hip replacement. The study evaluates wound healing, complications, and patient satisfaction regarding wound comfort and appearance after surgery. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- What is being tested?
- Insorb staples and metal staples (Ethicon metal stapler)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2007to 30 Apr 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Patient is 18 years or older
- Patient or legal representative is able to understand and provide signed consent for the procedure
- Patient is willing and able to return for required follow-up visits
- Patient needs a total hip arthroplasty surgical procedure
Who cannot join
- Patient has an active infection
- Patient is enrolled in another similar study
- Patient has a known history of hepatitis
- Patient has a known history of HIV
- Patient has a known history of AIDs
- Patient has a known history of IV drug abuse
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana Orthopaedic Hospital
Indianapolis, Indiana, 46278
About this study
The purpose of this study is to compare the use of INSORB absorbable staples with metal staples on surgical incision healing after total hip replacement. The study evaluates wound healing, complications, and patient satisfaction regarding wound comfort and appearance after surgery.
Read the detailed description
Subcuticular closure of wounds can provide superior results to percutaneous suture closure due to the elimination of suture or staple tracts. These tracts can lead to infection and migration of epithelial cells adding to scarring, and cross-hatching scars which remain after healing. Absorbable staples can provide a rapid, secure, subcuticular closure of skin as an alternative to the traditional, manual staple or suture closure. This study will compare INSORB absorbable staples to externally applied standard metal staples with respect to effectiveness of incision closure, acute healing, subject comfort level, security and appearance after total hip replacement.
- Being tested
- Insorb staples, metal staples (Ethicon metal stapler)
- Keywords
- Insorb staples, Metal Staples
- Medical subject headings
- Erythema, Contusions, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insorb staplesDevice
Also called Insorb absorbable stapler, GDW
absorbable staples required for wound closure
metal staples (Ethicon metal stapler)Device
Also called Ethicon metal stapler
wound closure with metal staples
| Study group | Role | What they receive |
|---|---|---|
| Insorb staples | Experimental | Subcuticular Absorbable staples Receives: Device: Insorb staples |
| Control | Active comparator | Metal staple wound closure Receives: Device: metal staples (Ethicon metal stapler) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participants With Incisional Drainage, Swelling or Gaps of Incision
Incisional drainage, swelling, gaps of incision. Drainage and swelling will be objectively determined by investigator. Gaps will be measured in millimeters.
Measured: Discharge from initial hospital stay (2-5 days post-op)
Secondary outcomes (1)
Participants With Wound Complications - Hematoma
Assessment of wound for complications, especially hematomas at 6 weeks post surgery. Participants will be scored based on presence of a hematoma or not.
Measured: up to 6 weeks post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2009 (estimated)
- Study startJul 2007
- Primary completion30 Apr 2010
- Study completion30 Apr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ErythemaStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orthopaedic Research Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- OrthoIndy
- Responsible party
- Sponsor
- Investigators
- David A Fisher, MD, Principal investigator, Indiana Orthopaedic Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00940446
- Sponsor's protocol ID
- DAF_PC000001
- Status last verified
- Jan 2018
- First submitted
- 14 Jul 2009
- Last updated
- 30 Jan 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of INSORB Staples With Metal Staples in Total Hip Replacement
- ClinicalTrials.gov ID
- NCT00940446
- Acronym / sponsor ID
- DAF_PC000001
- Keywords
- Insorb staples, Metal Staples
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Orthopaedic Research FoundationUniversity, hospital or other
- Collaborators
- OrthoIndy
- Study start
- Jul 2007
- Primary completion
- 30 Apr 2010 (actual)
- Study completion
- 30 Apr 2010 (actual)
- First posted
- 16 Jul 2009 (estimated)
- Results
- Posted 30 Jan 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the use of INSORB absorbable staples with metal staples on surgical incision healing after total hip replacement. The study evaluates wound healing, complications, and patient satisfaction regarding wound comfort and appearance after surgery.
Detailed description
Subcuticular closure of wounds can provide superior results to percutaneous suture closure due to the elimination of suture or staple tracts. These tracts can lead to infection and migration of epithelial cells adding to scarring, and cross-hatching scars which remain after healing. Absorbable staples can provide a rapid, secure, subcuticular closure of skin as an alternative to the traditional, manual staple or suture closure. This study will compare INSORB absorbable staples to externally applied standard metal staples with respect to effectiveness of incision closure, acute healing, subject comfort level, security and appearance after total hip replacement.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Insorb staples | Experimental | Device: Insorb staplesSubcuticular Absorbable staples |
| Control | Active comparator | Device: metal staples (Ethicon metal stapler)Metal staple wound closure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient is 18 years or older
- Patient or legal representative is able to understand and provide signed consent for the procedure
- Patient is willing and able to return for required follow-up visits
- Patient needs a total hip arthroplasty surgical procedure
Key exclusion criteria (6 listed)
- Patient has an active infection
- Patient is enrolled in another similar study
- Patient has a known history of hepatitis
- Patient has a known history of HIV
- Patient has a known history of AIDs
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 |
|---|---|---|
| Insorb staplesAlso: Insorb absorbable stapler, GDWabsorbable staples required for wound closure | Device | Insorb staples |
| metal staples (Ethicon metal stapler)Also: Ethicon metal staplerwound closure with metal staples | Device | Control |
Primary outcome
Participants With Incisional Drainage, Swelling or Gaps of Incision
Time frame: Discharge from initial hospital stay (2-5 days post-op)
Incisional drainage, swelling, gaps of incision. Drainage and swelling will be objectively determined by investigator. Gaps will be measured in millimeters.
1 secondary outcome
Participants With Wound Complications - Hematoma
Time frame: up to 6 weeks post-op
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
David A Fisher, MD principal investigator
Indiana Orthopaedic Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Insorb staples and metal staples (Ethicon metal stapler) in people with Erythema and Drainage, run by Orthopaedic Research Foundation 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 4 inclusion and 6 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 30 Jan 2018. 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?
Yes. Results are posted in the registry (first posted 30 Jan 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Participants With Incisional Drainage, Swelling or Gaps of Incision (time frame: Discharge from initial hospital stay (2-5 days post-op)). 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 30 Jan 2018.