Clinical trial NCT03338608: Platysma Incision Cosmesis
Official title: Influence of Platysmal Incision on Cosmetic Satisfaction Outcomes in Anterior Cervical Spine Surgery Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wound Heal
Keywords: Cosmesis
Wound Healing
Anterior Cervical Decompression and Fusion
ACDF
Platysma
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
First posted: 2017-11-09
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: There are two groups. One group will have the vertical platysma incision and the other group will have the transverse incision.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Modified version of the Hollander wound evaluation scale
timeFrame: 2 week follow up visit
measure: Modified version of the Hollander wound evaluation scale
timeFrame: 3 months follow up visit
measure: Modified version of the Hollander wound evaluation scale
timeFrame: 6 months follow up visit
measure: Modified version of the Hollander wound evaluation scale
timeFrame: 1 year follow up visit
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
Study officials:
affiliation: Boston Medical Center
name: Chadi Tannoury, MD
role: STUDY_CHAIR
References:
citation: Denaro V, Di Martino A. Cervical spine surgery: an historical perspective. Clin Orthop Relat Res. 2011 Mar;469(3):639-48. doi: 10.1007/s11999-010-1752-3.
citation: Fransen P. A simplified technique for anterior cervical discectomy and fusion using a screw-plate implanted over the Caspar distractor pins. Acta Orthop Belg. 2010 Aug;76(4):546-8.
citation: Fehlings MG, Arvin B. Surgical management of cervical degenerative disease: the evidence related to indications, impact, and outcome. J Neurosurg Spine. 2009 Aug;11(2):97-100. doi: 10.3171/2009.5.SPINE09210.