Platysma Incision Cosmesis

NCT03338608 | Completed

• 1 other identifier: H-36610
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Wound Heal

Keywords

Cosmesis; Wound Healing; Anterior Cervical Decompression and Fusion; ACDF; Platysma

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

Vertical Platysma Incision

EXPERIMENTAL

Patients in this arm who have anterior cervical decompression and fusion will receive the vertical platysma incision.

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

Transverse Platysma Incision

EXPERIMENTAL

Patients in this arm who have anterior cervical decompression and fusion will receive the transverse platysma incision.

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

Interventions

Anterior Cervical Decompression and Fusion PROCEDURE

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.

Transverse Platysma Incision; Vertical Platysma Incision

Vertical Platysma Incision PROCEDURE

A vertical platysma Incision will be used for the anterior cervical decompression and fusion surgical procedure

Vertical Platysma Incision

Transverse Platysma Incision PROCEDURE

A transverse platysma incision will be used for the anterior cervical decompression and fusion surgical procedure

Transverse Platysma Incision

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boston Medical Center: lead

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Related Publications (3)

• 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.

  PMID: 21213087 BACKGROUND

• 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.

  PMID: 20973364 BACKGROUND

• 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.

  PMID: 19769487 BACKGROUND

MeSH Terms

Interventions

Gene Fusion

Intervention Hierarchy (Ancestors)

Recombination, Genetic; Genetic Phenomena

Study Officials

• Chadi Tannoury, MD

  Boston Medical Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: There are two groups. One group will have the vertical platysma incision and the other group will have the transverse incision.

Study Record Dates

• First Submitted: November 3, 2017
• First Posted: November 9, 2017
• Study Start: November 26, 2018
• Primary Completion: September 15, 2019
• Study Completion: September 15, 2019
• Last Updated: July 7, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)