Staple Versus Suture Closure for Foot and Ankle Surgery

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.

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