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Platysma Incision Cosmesis

Boston Medical Center (BMC) logo

Boston Medical Center (BMC)

Status

Completed

Conditions

Wound Heal

Treatments

Procedure: Anterior Cervical Decompression and Fusion
Procedure: Transverse Platysma Incision
Procedure: Vertical Platysma Incision

Study type

Interventional

Funder types

Other

Identifiers

NCT03338608
H-36610

Details and patient eligibility

About

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.

Enrollment

22 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

22 participants in 2 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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