Platysma Incision Cosmesis

Not Applicable

Completed

• Conditions: Wound Heal
• Interventions: Procedure: Anterior Cervical Decompression and Fusion; Procedure: Vertical Platysma Incision; Procedure: Transverse Platysma Incision

• Registration Number: NCT03338608
• Lead Sponsor: Boston Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-11-03
• Study First Submitted QC: 2017-11-08
• Study First Posted: 2017-11-09
• Study Start: 2018-11-26
• Primary Completion: 2019-09-15
• Study Completion: 2019-09-15
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-05
• Last Update Posted: 2020-07-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vertical Platysma Incision	Vertical Platysma Incision	Patients in this arm who have anterior cervical decompression and fusion will receive the vertical platysma incision.
Vertical Platysma Incision	Anterior Cervical Decompression and Fusion	Patients in this arm who have anterior cervical decompression and fusion will receive the vertical platysma incision.
Transverse Platysma Incision	Transverse Platysma Incision	Patients in this arm who have anterior cervical decompression and fusion will receive the transverse platysma incision.
Transverse Platysma Incision	Anterior Cervical Decompression and Fusion	Patients in this arm who have anterior cervical decompression and fusion will receive the transverse platysma incision.

Primary Outcome Measures

Name	Time	Method
Modified version of the Hollander wound evaluation scale	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

Trial Locations

Locations (1)

Boston Medical Center; 🇺🇸 Boston, Massachusetts, United States