IncisionNCT03522753
Staple Versus Suture Closure for Foot and Ankle Surgery
A study testing Metal skin staples and Nylon sutures in people with Incision and Foot Ankle Injuries, run by University of Alabama at Birmingham.
Trial summary
This study aims to determine if staples or sutures are better for the closure of uncomplicated foot and ankle surgeries. Currently, most surgeons base their choice for closure on previous teaching from a mentor during fellowship or personal experience. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Incision, Foot Ankle Injuries
- What is being tested?
- Metal skin staples and Nylon sutures
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2018to 15 Sep 2023
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Over 18 years of age
- Scheduled to undergo any elective foot or ankle procedures with one of our included surgeons investigators during the approved protocol period.
- Patients with comorbidities such as rheumatoid arthritis, diabetes, and other systemic diseases will still be included so long as they are not considered uncontrolled or immunocompromised.
- In patients with rheumatoid arthritis, the usual protocol for discontinuing disease-modifying antirheumatic drugs (DMARDs) prior to surgery will be continued as done per each surgeon's protocol.
- Patients undergoing urgent surgery (e.g. within a few days of the inciting event, such as a traumatic fracture) will be considered for the study.
Who cannot join
- Patients under 18 years old
- Patients who are not competent to give consent for themselves, or to read and answer questions about their scar formation (proxies will not be allowed);
- Any surgery that requires a non-linear surgical incision;
- Previous surgery(ies) on the same area;
- Known history of keloid/abnormal scar formation;
- Patients with uncontrolled diabetes (as documented by ICD-9 codes 250.x2 or 250.x3);
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- Patients who are immunocompromised (i.e. HIV/AIDS+ patients, patients who have had a previous organ transplantation, patients who have been diagnosed with an immunodeficiency syndrome- congenital or acquired, as a result of immunomodulatory medication secondary to autoimmune disease, or undergoing current chemotherapy for cancer).
- Patients undergoing emergent surgery will not be considered for the study.
- Patients who have had a previous allergic or adverse reaction to any of the suture/staple materials we plan to use will not be included.
- If the closure requires multiple layers of sutures (i.e. subcutaneous layers, deep dermal layers) in addition to the usual closing staples/sutures which are through the skin, the patient will be excluded from the study
About this study
This study aims to determine if staples or sutures are better for the closure of uncomplicated foot and ankle surgeries. Currently, most surgeons base their choice for closure on previous teaching from a mentor during fellowship or personal experience. There is no standard of care for closure material on hand surgeries to date. This study will prospectively randomize patients to have either staple or suture wound closure if they have a short incision. In surgeries with longer incisions (i.e. 5+ cm), or multiple incisions on similar sites (i.e. bilateral operations, multiple toes), patients will have half sutures and half staple closure. The three primary measured outcomes will be: pain upon suture/staple removal, time to place and remove sutures vs. staples, and scar formation.
Read the detailed description
The material used for closure of surgical incision is often considered "dealer's choice" and usually is chosen from one (or a combination) of the following techniques: subcutaneous absorbable sutures, interrupted simple/mattress dermal sutures, or dermal staples. Factors that are typically taken into consideration include anatomic location, amount of tension involved in closure, shape of the incision and integrity of the skin involved in the closure, need for cosmesis, and surgeon comfort/past experience with different closure techniques.
Previous randomized controlled trials, as well as meta-analyses, have analyzed sutures versus staples in orthopaedic surgeries, but often exclude foot and ankle surgeries as incisions are typically small and require more delicate closures. In RCTs involving other areas of the body, staples have been found to result in less wound infection and less time to insert/remove compared to sutures. They were also comparable to sutures in cosmetic result and patient satisfaction. These results are not known for surgeries of the foot and ankle.
Both sutures and staples are routinely used during a typical foot and ankle surgery, without significant risk of wound dehiscence or complications.
This study aims to determine if staples or sutures are better for the closure of uncomplicated foot and ankle surgeries. Currently, most surgeons base their choice for closure on previous teaching from a mentor during fellowship or personal experience. There is no standard of care for closure material on hand surgeries to date. This study will prospectively randomize patients to have either staple or suture wound closure if they have a short incision. In surgeries with longer incisions (i.e. 5+ cm), or multiple incisions on similar sites (i.e. bilateral operations, multiple toes), patients will have half sutures and half staple closure. The three primary measured outcomes will be: pain upon suture/staple removal, time to place and remove sutures vs. staples, and scar formation.
- Conditions
- Incision, Foot Ankle Injuries
- Being tested
- Metal skin staples, Nylon sutures
- Medical subject headings
- Surgical Wound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metal skin staplesDevice
Also called metal clips, skin clips, staples
Routine closure methods/material for surgical wounds
Nylon suturesDevice
Also called sutures
Routine closure methods/material for surgical wounds
| Study group | Role | What they receive |
|---|---|---|
| Staples | Experimental | For short single incisions, these patients will receive superficial closure using only metal skin staples. Closure will be performed by resident or fellow involved in the case. Receives: Device: Metal skin staples |
| Suture | Active comparator | For short single incisions, these patients will receive superficial closure using only nylon sutures. No metal skin staples will be used. Closure will be performed by resident or fellow involved in the case. Receives: Device: Nylon sutures |
| Half Staple Half Suture | Other | Some patients will receive both nylon sutures and metal skin staples for superficial closure. If multiple incisions are involved, each incision will count as 1 in the alternation method (i.e. toe 1 will be all sutures, then toe 2 will be all staples). For long incisions, closure will alternate between nylon sutures and metal skin staples on the part of the incision which is closer (more proximal) or farther away (more distal) from the rest of the body. Receives: Device: Metal skin staples; Device: Nylon sutures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain on removal
Visual Analog Scale (VAS) Pain Score; Scale 0-10, where 0=no pain and 10=worst possible pain
Measured: At time of device removal (10-14 days post-op)
Secondary outcomes (2)
Time to place and remove
Time in seconds to place and remove device
Measured: At time of surgery and at time of device removal (10-14 days post-op)
Scar formation
Modified Patient and Observer Scar Assessment Scale (POSAS) Questionnaire. This questionnaire rates scar formation using two total scores, each between 6-60 points (lower score is better), one completed by the patient (patient scale) and one by an observer (observer scale). The total score for each scale is the sum of 6 equally weighted questionnaire items (each scoring 1-10 points; lower score is better). In addition, both patient and observer give overall opinion of scarring, on a 1-10 scale; lower score is better. Overall opinions reported separately from total scores.
Measured: At time of device removal (10-14 days post-op), at 6 weeks, 3 months, and 1 year 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 May 2018
- Study start1 Sep 2018
- Primary completion1 Oct 2022
- Study completion15 Sep 2023
Why it stopped: Resolving database issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IncisionStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ashish Shah, University of Alabama at Birmingham
- Investigators
- Ashish Shah, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03522753
- Sponsor's protocol ID
- IRB-300001258
- Status last verified
- Sep 2023
- First submitted
- 1 May 2018
- Last updated
- 18 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Only investigators involved in the research protocol will have knowledge of any patient involvement. Research meetings will be closed to any other participants and will be conducted in a closed office setting away from passersby. Documents with any kind of patient information/involvement will be kept on a secure, password protected server that cannot be accessed by those not involved with the protocol. Similarly, consent forms will be kept in the office of the principal investigator in a locked drawer. Research data will be stored on a secure server which is only accessible by investigators who have been individually allowed access to the project. Only aggregate or unidentifiable data will be published.
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Staple Versus Suture Closure for Foot and Ankle Surgery
- ClinicalTrials.gov ID
- NCT03522753
- Acronym / sponsor ID
- IRB-300001258
- Conditions
- Incision, Foot Ankle Injuries
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Resolving database issues
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 1 Oct 2022 (actual)
- Study completion
- 15 Sep 2023 (actual)
- First posted
- 11 May 2018 (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 study aims to determine if staples or sutures are better for the closure of uncomplicated foot and ankle surgeries. Currently, most surgeons base their choice for closure on previous teaching from a mentor during fellowship or personal experience. There is no standard of care for closure material on hand surgeries to date. This study will prospectively randomize patients to have either staple or suture wound closure if they have a short incision. In surgeries with longer incisions (i.e. 5+ cm), or multiple incisions on similar sites (i.e. bilateral operations, multiple toes), patients will have half sutures and half staple closure. The three primary measured outcomes will be: pain upon suture/staple removal, time to place and remove sutures vs. staples, and scar formation.
Detailed description
The material used for closure of surgical incision is often considered "dealer's choice" and usually is chosen from one (or a combination) of the following techniques: subcutaneous absorbable sutures, interrupted simple/mattress dermal sutures, or dermal staples. Factors that are typically taken into consideration include anatomic location, amount of tension involved in closure, shape of the incision and integrity of the skin involved in the closure, need for cosmesis, and surgeon comfort/past experience with different closure techniques.
Previous randomized controlled trials, as well as meta-analyses, have analyzed sutures versus staples in orthopaedic surgeries, but often exclude foot and ankle surgeries as incisions are typically small and require more delicate closures. In RCTs involving other areas of the body, staples have been found to result in less wound infection and less time to insert/remove compared to sutures. They were also comparable to sutures in cosmetic result and patient satisfaction. These results are not known for surgeries of the foot and ankle.
Both sutures and staples are routinely used during a typical foot and ankle surgery, without significant risk of wound dehiscence or complications.
This study aims to determine if staples or sutures are better for the closure of uncomplicated foot and ankle surgeries. Currently, most surgeons base their choice for closure on previous teaching from a mentor during fellowship or personal experience. There is no standard of care for closure material on hand surgeries to date. This study will prospectively randomize patients to have either staple or suture wound closure if they have a short incision. In surgeries with longer incisions (i.e. 5+ cm), or multiple incisions on similar sites (i.e. bilateral operations, multiple toes), patients will have half sutures and half staple closure. The three primary measured outcomes will be: pain upon suture/staple removal, time to place and remove sutures vs. staples, and scar formation.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Staples | Experimental | Device: Metal skin staplesFor short single incisions, these patients will receive superficial closure using only metal skin staples. Closure will be performed by resident or fellow involved in the case. |
| Suture | Active comparator | Device: Nylon suturesFor short single incisions, these patients will receive superficial closure using only nylon sutures. No metal skin staples will be used. Closure will be performed by resident or fellow involved in the case. |
| Half Staple Half Suture | Other | Device: Metal skin staples, Device: Nylon suturesSome patients will receive both nylon sutures and metal skin staples for superficial closure. If multiple incisions are involved, each incision will count as 1 in the alternation method (i.e. toe 1 will be all sutures, then toe 2 will be all staples). For long incisions, closure will alternate between nylon sutures and metal skin staples on the part of the incision which is closer (more proximal) or farther away (more distal) from the rest of the body. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Over 18 years of age
- Scheduled to undergo any elective foot or ankle procedures with one of our included surgeons investigators during the approved protocol period.
- Patients with comorbidities such as rheumatoid arthritis, diabetes, and other systemic diseases will still be included so long as they are not considered uncontrolled or immunocompromised.
- In patients with rheumatoid arthritis, the usual protocol for discontinuing disease-modifying antirheumatic drugs (DMARDs) prior to surgery will be continued as done per each surgeon's protocol.
- Patients undergoing urgent surgery (e.g. within a few days of the inciting event, such as a traumatic fracture) will be considered for the study.
Key exclusion criteria (10 listed)
- Patients under 18 years old
- Patients who are not competent to give consent for themselves, or to read and answer questions about their scar formation (proxies will not be allowed);
- Any surgery that requires a non-linear surgical incision;
- Previous surgery(ies) on the same area;
- Known history of keloid/abnormal scar formation;
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 |
|---|---|---|
| Metal skin staplesAlso: metal clips, skin clips, staplesRoutine closure methods/material for surgical wounds | Device | Half Staple Half Suture, Staples |
| Nylon suturesAlso: suturesRoutine closure methods/material for surgical wounds | Device | Half Staple Half Suture, Suture |
Primary outcome
Pain on removal
Time frame: At time of device removal (10-14 days post-op)
Visual Analog Scale (VAS) Pain Score; Scale 0-10, where 0=no pain and 10=worst possible pain
2 secondary outcomes
Time to place and remove
Time frame: At time of surgery and at time of device removal (10-14 days post-op)
Scar formation
Time frame: At time of device removal (10-14 days post-op), at 6 weeks, 3 months, and 1 year post-op
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2023.
- Individual participant dataSharing planned: No. Only investigators involved in the research protocol will have knowledge of any patient involvement. Research meetings will be closed to any other participants and will be conducted in a closed office setting away from passersby. Documents with any kind of patient information/involvement will be kept on a secure, password protected server that cannot be accessed by those not involved with the protocol. Similarly, consent forms will be kept in the office of the principal investigator in a locked drawer. Research data will be stored on a secure server which is only accessible by investigators who have been individually allowed access to the project. Only aggregate or unidentifiable data will be published.
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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.
Ashish Shah, MD principal investigator
University of Alabama at Birmingham
Questions about this trial
What is this clinical trial studying?
A study testing Metal skin staples and Nylon sutures in people with Incision and Foot Ankle Injuries, run by University of Alabama at Birmingham.
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 5 inclusion and 10 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: withdrawn, as of the sponsor's last update on 18 Sep 2023. 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 was withdrawn before enrolling participants, so there are no results.
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?
Pain on removal (time frame: At time of device removal (10-14 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 18 Sep 2023.