Staple Versus Suture Closure for Foot and Ankle Surgery

NCT03522753 | Withdrawn FDA Device

• 1 other identifier: IRB-300001258
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Incision; Foot Ankle Injuries

Outcome Measures

Primary Outcomes (1)

• Pain on removal

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

  At time of device removal (10-14 days post-op)

Secondary Outcomes (2)

• Time to place and remove

  At time of surgery and at time of device removal (10-14 days post-op)

• Scar formation

  At time of device removal (10-14 days post-op), at 6 weeks, 3 months, and 1 year post-op

Study Arms (3)

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.

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.

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.

Device: Metal skin staples; Device: Nylon sutures

Interventions

Metal skin staples DEVICE

Routine closure methods/material for surgical wounds

Also known as: metal clips, skin clips, staples

Half Staple Half Suture; Staples

Nylon sutures DEVICE

Routine closure methods/material for surgical wounds

Also known as: sutures

Half Staple Half Suture; Suture

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

MeSH Terms

Conditions

Surgical Wound

Interventions

Sutures

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Surgical Fixation Devices; Surgical Equipment; Equipment and Supplies

Study Officials

• Ashish Shah, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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).
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 1, 2018
• First Posted: May 11, 2018
• Study Start: September 1, 2018
• Primary Completion: October 1, 2022
• Study Completion: September 15, 2023
• Last Updated: September 18, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share