Ankle FracturesNCT06496698
Impact of Suture Technique on Wound Healing in Ankle Fracture Surgery: A Randomized Controlled Trial
A study testing Simple Interrupted Suture and Subcuticular Suture in people with Ankle Fractures, run by University of Puerto Rico.
Trial summary
Our primary aim is to compare the complication rates of patients with ankle fractures who underwent skin closure using a running subcuticular suture pattern compared to an interrupted suture pattern. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Ankle Fractures
- What is being tested?
- Simple Interrupted Suture and Subcuticular Suture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 15 Jul 2024to 15 Jul 2026
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 21 years or older with isolated ankle fractures requiring surgical intervention and who consent to participate.
Who cannot join
- Patients that will be excluded from this study include those with complex ankle fractures, open fractures, a history of wound healing disorders, and/or those unable to provide consent.
Trial locations and contacts
No sites are listed yet.
About this study
Our primary aim is to compare the complication rates of patients with ankle fractures who underwent skin closure using a running subcuticular suture pattern compared to an interrupted suture pattern. At the time of the operation, participants will be assigned to either the Subcuticular Suture Group (SSG) or the Simple Interrupted Suture Group (SISG) using computer-generated randomization programs. The surgeon will perform the assigned closure technique using standardized techniques. Running subcuticular Vicryl 3-0 sutures will be placed on patients in the experimental group while simple interrupted Monocryl 3-0 sutures patients in our control group.
Patients will be followed up at the two-week and eight-week postoperative mark where we will use the Patient and Observer Scar Assessment Scale (POSAS) to evaluate and compare wound healing. Additionally, photographs of the scars will be captured to visually assess the healing progression.
- Conditions
- Ankle Fractures
- Being tested
- Simple Interrupted Suture, Subcuticular Suture
- Medical subject headings
- Ankle Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simple Interrupted SutureProcedure or surgery
In the control group, simple interrupted sutures will be used for wound closure after surgical repair of ankle fractures.
Subcuticular SutureProcedure or surgery
In the experimental group, subcuticular sutures will be used for wound closure after surgical repair of ankle fractures.
| Study group | Role | What they receive |
|---|---|---|
| Subcuticular Suture Group | Experimental | Running subcuticular Vicryl 3-0 sutures will be placed on patients in the experimental group. Receives: Procedure: Subcuticular Suture |
| Simple Interrupted Suture Group | Active comparator | Simple interrupted Monocryl 3-0 sutures will be placed on patients in the control group. Receives: Procedure: Simple Interrupted Suture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Complication rates
Complications include wound infection, dehiscence, suture breakage, suture abscess, necrosis, allergic reactions, malunion, hardware failure, and the need for reoperation or revision surgery.
Measured: 2 and 8 weeks post-op.
Secondary outcomes (2)
Patient and Observer Scar Assessment Scale (POSAS)
The Patient and Observer Scar Assessment Scale (POSAS) is a comprehensive tool used to evaluate the quality of scars from both the patient's and observer's perspectives. It consists of two parts: the Patient Scale and the Observer Scale.
Measured: 2 and 8 weeks post-op.
Self-reported foot and ankle score (SEFAS)
Consists of 12 items related to pain, limping, swelling, and use of orthotics and walking.
Measured: 2 and 8 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 posted11 Jul 2024
- Study start15 Jul 2024 (estimated)
- Primary completion15 Jul 2026 (estimated)
- Study completion15 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle FracturesStudies 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
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Puerto Rico
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06496698
- Sponsor's protocol ID
- 117966
- Status last verified
- Jun 2024
- First submitted
- 3 Jul 2024
- Last updated
- 11 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Suture Technique on Wound Healing in Ankle Fracture Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06496698
- Acronym / sponsor ID
- 117966
- Conditions
- Ankle Fractures
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of Puerto RicoUniversity, hospital or other
- Study start
- 15 Jul 2024 (estimated)
- Primary completion
- 15 Jul 2026 (estimated)
- Study completion
- 15 Jul 2026 (estimated)
- First posted
- 11 Jul 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.
Our primary aim is to compare the complication rates of patients with ankle fractures who underwent skin closure using a running subcuticular suture pattern compared to an interrupted suture pattern. At the time of the operation, participants will be assigned to either the Subcuticular Suture Group (SSG) or the Simple Interrupted Suture Group (SISG) using computer-generated randomization programs. The surgeon will perform the assigned closure technique using standardized techniques. Running subcuticular Vicryl 3-0 sutures will be placed on patients in the experimental group while simple interrupted Monocryl 3-0 sutures patients in our control group.
Patients will be followed up at the two-week and eight-week postoperative mark where we will use the Patient and Observer Scar Assessment Scale (POSAS) to evaluate and compare wound healing. Additionally, photographs of the scars will be captured to visually assess the healing progression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subcuticular Suture Group | Experimental | Procedure: Subcuticular SutureRunning subcuticular Vicryl 3-0 sutures will be placed on patients in the experimental group. |
| Simple Interrupted Suture Group | Active comparator | Procedure: Simple Interrupted SutureSimple interrupted Monocryl 3-0 sutures will be placed on patients in the control group. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients aged 21 years or older with isolated ankle fractures requiring surgical intervention and who consent to participate.
Key exclusion criteria (1 listed)
- Patients that will be excluded from this study include those with complex ankle fractures, open fractures, a history of wound healing disorders, and/or those unable to provide consent.
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 |
|---|---|---|
| Simple Interrupted SutureIn the control group, simple interrupted sutures will be used for wound closure after surgical repair of ankle fractures. | Procedure or surgery | Simple Interrupted Suture Group |
| Subcuticular SutureIn the experimental group, subcuticular sutures will be used for wound closure after surgical repair of ankle fractures. | Procedure or surgery | Subcuticular Suture Group |
Primary outcome
Postoperative Complication rates
Time frame: 2 and 8 weeks post-op.
Complications include wound infection, dehiscence, suture breakage, suture abscess, necrosis, allergic reactions, malunion, hardware failure, and the need for reoperation or revision surgery.
2 secondary outcomes
Patient and Observer Scar Assessment Scale (POSAS)
Time frame: 2 and 8 weeks post-op.
Self-reported foot and ankle score (SEFAS)
Time frame: 2 and 8 weeks post-op.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2024.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Simple Interrupted Suture and Subcuticular Suture in people with Ankle Fractures, run by University of Puerto Rico.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 11 Jul 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact José Acosta, MD (787-758-2525 ext. 1907, jose.acosta14@upr.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Complication rates (time frame: 2 and 8 weeks 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 11 Jul 2024.