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Staple Versus Suture Closure for Foot and Ankle Surgery

Primary Purpose

Incision, Foot Ankle Injuries

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Metal skin staples
Nylon sutures
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Incision

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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);
  • 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Active Comparator

    Other

    Arm Label

    Staples

    Suture

    Half Staple Half Suture

    Arm Description

    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.

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Pain on removal
    Visual Analog Scale (VAS) Pain Score; Scale 0-10, where 0=no pain and 10=worst possible pain

    Secondary Outcome Measures

    Time to place and remove
    Time in seconds to place and remove device
    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.

    Full Information

    First Posted
    May 1, 2018
    Last Updated
    September 15, 2023
    Sponsor
    University of Alabama at Birmingham
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03522753
    Brief Title
    Staple Versus Suture Closure for Foot and Ankle Surgery
    Official Title
    Staple Versus Suture Closure for Foot and Ankle Surgery
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Resolving database issues
    Study Start Date
    September 1, 2018 (Actual)
    Primary Completion Date
    October 1, 2022 (Actual)
    Study Completion Date
    September 15, 2023 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Alabama at Birmingham

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    Yes
    Product Manufactured in and Exported from the U.S.
    No

    5. Study Description

    Brief 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. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Incision, Foot Ankle Injuries

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Masking Description
    The resident/fellow performing closure will know what has been done for their patient, but blinded to other participants. Splints or other dressings will cover the closure. Patients will be physically "blinded" (i.e. eye cover) during the removal procedure. Patients and observers will assess scar appearance. "Observers" are the blinded surgeon or other blinded medical personnel (nurse, research assistant, CRNP, or resident/fellow who was not involved).
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Staples
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Suture
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    Half Staple Half Suture
    Arm Type
    Other
    Arm Description
    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.
    Intervention Type
    Device
    Intervention Name(s)
    Metal skin staples
    Other Intervention Name(s)
    metal clips, skin clips, staples
    Intervention Description
    Routine closure methods/material for surgical wounds
    Intervention Type
    Device
    Intervention Name(s)
    Nylon sutures
    Other Intervention Name(s)
    sutures
    Intervention Description
    Routine closure methods/material for surgical wounds
    Primary Outcome Measure Information:
    Title
    Pain on removal
    Description
    Visual Analog Scale (VAS) Pain Score; Scale 0-10, where 0=no pain and 10=worst possible pain
    Time Frame
    At time of device removal (10-14 days post-op)
    Secondary Outcome Measure Information:
    Title
    Time to place and remove
    Description
    Time in seconds to place and remove device
    Time Frame
    At time of surgery and at time of device removal (10-14 days post-op)
    Title
    Scar formation
    Description
    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.
    Time Frame
    At time of device removal (10-14 days post-op), at 6 weeks, 3 months, and 1 year post-op

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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. Exclusion Criteria: 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); 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ashish Shah, MD
    Organizational Affiliation
    University of Alabama at Birmingham
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    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.

    Learn more about this trial

    Staple Versus Suture Closure for Foot and Ankle Surgery

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