Platysma Incision Cosmesis

Study Overview
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Brief Summary
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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.

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

Conditions
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Wound Heal

Intervention / Treatment
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* Procedure: Anterior Cervical Decompression and Fusion
* Procedure: Vertical Platysma Incision
* Procedure: Transverse Platysma Incision


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: There are two groups. One group will have the vertical platysma incision and the other group will have the transverse incision.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vertical Platysma Incision<br>Patients in this arm who have anterior cervical decompression and fusion will receive the vertical platysma incision. | Procedure: Anterior Cervical Decompression and Fusion<br>* Patients will receive the anterior cervical decompression and fusion as part of their standard of care. They will be randomized to either receive the vertical or transverse platysma incision.<br>Procedure: Vertical Platysma Incision<br>* A vertical platysma Incision will be used for the anterior cervical decompression and fusion surgical procedure<br>|
| Experimental: Transverse Platysma Incision<br>Patients in this arm who have anterior cervical decompression and fusion will receive the transverse platysma incision. | Procedure: Anterior Cervical Decompression and Fusion<br>* Patients will receive the anterior cervical decompression and fusion as part of their standard of care. They will be randomized to either receive the vertical or transverse platysma incision.<br>Procedure: Transverse Platysma Incision<br>* A transverse platysma incision will be used for the anterior cervical decompression and fusion surgical procedure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified version of the Hollander wound evaluation scale | Includes several factors of cosmetic wound healing (skin puckering, patient satisfaction, etc.). Based on photographic and patient follow-up information | 2 week follow up visit | 
| Modified version of the Hollander wound evaluation scale | Includes several factors of cosmetic wound healing (skin puckering, patient satisfaction, etc.). Based on photographic and patient follow-up information | 3 months follow up visit | 
| Modified version of the Hollander wound evaluation scale | Includes several factors of cosmetic wound healing (skin puckering, patient satisfaction, etc.). Based on photographic and patient follow-up information | 6 months follow up visit | 
| Modified version of the Hollander wound evaluation scale | Includes several factors of cosmetic wound healing (skin puckering, patient satisfaction, etc.). Based on photographic and patient follow-up information | 1 year follow up visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cosmesis, Wound Healing, Anterior Cervical Decompression and Fusion, ACDF, Platysma