Lower Extremity FractureSvSNCT06586814
Suture Versus Staples for Wound Closure in Orthopaedic Trauma Surgery
A study testing Suture and Staple in people with Lower Extremity Fracture, run by University of Southern California at 1 site in United States.
Trial summary
This pilot study is designed to assess the feasibility of comparing skin closure methods - sutures versus staples - and subsequent rates of surgical site infection following open reduction and internal fixation surgery for orthopaedic trauma injuries. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Lower Extremity Fracture
- What is being tested?
- Suture and Staple
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult Patients 18-80 years old
- Tibial Pilon, Tibial Plateau Fractures, Patella Fractures, and Distal Femur Fractures
- Incisions must be able to be approximated with subdermal sutures intraoperatively
- English and Spanish speaking patients only
Who cannot join
- Open fractures
- Incarcerated patients
- Pregnant patients
- Patients who do not speak English or Spanish
- History of infection at surgical incision site at the time of definitive fixation
- Pre-existing skin condition associated with risk of infection (psoriasis, eczema)
- Unable to obtain consent from patient prior to surgery or from legally authorized representative (LAR) prior to skin closure if the patient is unable to consent dur to their medical condition.
- The absence of a subcutaneous closure during the index procedure
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Southern California
Los Angeles, California, 90033
About this study
Official title: A Randomized Study of Suture Versus Staples for Wound Closure in Orthopaedic Trauma Surgery
This pilot study is designed to assess the feasibility of comparing skin closure methods - sutures versus staples - and subsequent rates of surgical site infection following open reduction and internal fixation surgery for orthopaedic trauma injuries. The primary objectives are to determine if enrollment, randomization, and compliance are feasible and to refine data collection methods. Patients =18 years of age with closed fractures of the tibial plateau, tibial pilon, patella, and distal femur presenting within 3 weeks of injury undergoing definitive treatment of their fracture will be approached for participation. If enrolled, they will be randomized to having their surgical wound closed with either nylon sutures or metallic staples. Patient follow up will be standard of care besides answering PROMIS surveys.
- Conditions
- Lower Extremity Fracture
- Being tested
- Suture, Staple
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SutureOther
Wound Closure
StapleOther
Wound Closure
| Study group | Role | What they receive |
|---|---|---|
| Suture | Other | Wound Closure Receives: Other: Suture |
| Staple | Other | Wound Closure Receives: Other: Staple |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of participant enrollment
- Hitting target enrollment in 12 months, enrolling 50% of eligible patients
Measured: 12 Months
Feasibility of randomization to each of the treatments
- Rate of consent
Measured: 6 Months
Assess Protocol Compliance
- Percentage of survey completion
- Percentage of follow-up
- Percentage of completed planned outcomes measures
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Aug 2024
- Primary completion31 Dec 2025
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Extremity FractureStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joshua Gary, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06586814
- Sponsor's protocol ID
- HS-24-00012
- Acronym
- SvS
- Status last verified
- Mar 2026
- First submitted
- 19 Jul 2024
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Study of Suture Versus Staples for Wound Closure in Orthopaedic Trauma Surgery
- ClinicalTrials.gov ID
- NCT06586814
- Acronym / sponsor ID
- SvS / HS-24-00012
- Conditions
- Lower Extremity Fracture
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 19 Sep 2024 (actual)
- 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.
This pilot study is designed to assess the feasibility of comparing skin closure methods - sutures versus staples - and subsequent rates of surgical site infection following open reduction and internal fixation surgery for orthopaedic trauma injuries. The primary objectives are to determine if enrollment, randomization, and compliance are feasible and to refine data collection methods. Patients =18 years of age with closed fractures of the tibial plateau, tibial pilon, patella, and distal femur presenting within 3 weeks of injury undergoing definitive treatment of their fracture will be approached for participation. If enrolled, they will be randomized to having their surgical wound closed with either nylon sutures or metallic staples. Patient follow up will be standard of care besides answering PROMIS surveys.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Suture | Other | Other: SutureWound Closure |
| Staple | Other | Other: StapleWound Closure |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult Patients 18-80 years old
- Tibial Pilon, Tibial Plateau Fractures, Patella Fractures, and Distal Femur Fractures
- Incisions must be able to be approximated with subdermal sutures intraoperatively
- English and Spanish speaking patients only
Key exclusion criteria (8 listed)
- Open fractures
- Incarcerated patients
- Pregnant patients
- Patients who do not speak English or Spanish
- History of infection at surgical incision site at the time of definitive fixation
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 |
|---|---|---|
| SutureWound Closure | Other | Suture |
| StapleWound Closure | Other | Staple |
Primary outcome
Feasibility of participant enrollment
Time frame: 12 Months
- Hitting target enrollment in 12 months, enrolling 50% of eligible patients
Feasibility of randomization to each of the treatments
Time frame: 6 Months
- Rate of consent
Assess Protocol Compliance
Time frame: 6 Months
* Percentage of survey completion * Percentage of follow-up * Percentage of completed planned outcomes measures
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Individual participant dataSharing planned: No
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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.
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 Suture and Staple in people with Lower Extremity Fracture, run by University of Southern California 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 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: under way, not looking for participants, as of the sponsor's last update on 27 Mar 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Feasibility of participant enrollment (time frame: 12 Months). The study lists 3 primary outcomes in all. 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 27 Mar 2026.