Staple Versus Suture Closure for Foot and Ankle Surgery
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Pain on removal
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
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).
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Pain on removal
时间窗: 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
次要结局
- 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)
研究者
Ashish Shah
Assistant Professor
University of Alabama at Birmingham