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临床试验/NCT03338608
NCT03338608已完成不适用

Influence of Platysmal Incision on Cosmetic Satisfaction Outcomes in Anterior Cervical Spine Surgery Patients

Boston Medical Center2 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2018年11月26日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
22
试验地点
2
主要终点
Modified version of the Hollander wound evaluation scale

研究概览

简要总结

The anterior cervical fusion and decompression (ACDF) surgery provides direct access to symptomatic areas of the cervical spine. Cosmesis, including factors like wound healing, is an important issue for patients who undergo surgery on anterior neck structures. One significant factor that impacts cosmetic healing in patients who undergo the ACDF surgery is whether a vertical or transverse incision of the platysma muscle in the neck was used to access the cervical spine.

The purpose of the present study is to compare cosmetic outcomes in vertical versus transverse platysmal incisions for anterior cervical spine exposures. Researchers intend to analyze this effect with a prospective comparative study model. A targeted number of 100 patients who undergo anterior cervical surgery, as part of their standard of care, will be randomized to receive either a transverse or vertical platysmal incision during the exposure part of their procedure. Informed consent for inclusion in the study, as approved by the Institutional Review Board, will be obtained from all patients in addition to consent for the surgical procedure. Regardless of the platysmal incision, all patients will receive a standard transverse skin incision, as is done routinely in anterior cervical exposures. After the surgery, all closures will be done in a standard manner.

These patients will be followed up in the clinic at two weeks, three months, six months, and one year. They will be evaluated for wound healing and incision cosmesis using a modification of The Hollander Wound Evaluation Scale. Clinical photographs of the patients' necks will be captured during these visits in a manner that does not reveal any patient identifiers in any way. The incisions and overall cosmesis will be graded using the scale mentioned above. The data will be analyzed to determine if a transverse platysmal incision offers better cosmetic results than a vertical platysmal incision, or vice versa, and will also be used to validate the modified wound evaluation scale.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All patients undergoing elective Anterior Cervical Decompression and Fusion surgery for degenerative spinal pathologies by Dr. Tony Tannoury or Dr. Chadi Tannoury at Boston Medical Center as part of their standard of care.

排除标准

  • Patients undergoing revision anterior cervical spine surgeries with a pre-existing scar. Patients with cervical spine tumors/neoplastic pathologies. Patients undergoing surgery for cervical spine trauma.

结局指标

主要结局

Modified version of the Hollander wound evaluation scale

时间窗: 1 year follow up visit

Includes several factors of cosmetic wound healing (skin puckering, patient satisfaction, etc.). Based on photographic and patient follow-up information

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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