Staple Versus Suture Closure for Foot and Ankle Surgery

Not Applicable

Withdrawn

• Conditions: Incision; Foot Ankle Injuries
• Interventions: Device: Nylon sutures; Device: Metal skin staples

• Registration Number: NCT03522753
• Lead Sponsor: University of Alabama at Birmingham

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.

Study Timeline

• Study First Submitted: 2018-05-01
• Study First Submitted QC: 2018-05-01
• Study First Posted: 2018-05-11
• Study Start: 2018-09-01
• Primary Completion: 2022-10-01
• Status Verified: 2023-09
• Study Completion: 2023-09-15
• Last Update Submitted: 2023-09-15
• Last Update Posted: 2023-09-18

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Suture	Nylon sutures	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.
Half Staple Half Suture	Metal skin staples	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.
Staples	Metal skin staples	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.
Half Staple Half Suture	Nylon sutures	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.

Primary Outcome Measures

Name	Time	Method
Pain on removal	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

Secondary Outcome Measures

Name	Time	Method
Time to place and remove	At time of surgery and at time of device removal (10-14 days post-op)	Time in seconds to place and remove device
Scar formation	At time of device removal (10-14 days post-op), at 6 weeks, 3 months, and 1 year post-op	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.