Platysma Incision Cosmesis

Wound Heal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03338608
• Other study ID #: H-36610
• Status: Completed
• Phase: N/A
• Start date: November 26, 2018
• Est. completion date: September 15, 2019

Study information

• Verified date: July 2020
• Source: Boston Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: September 15, 2019
• Est. primary completion date: September 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Surgical Wound
• Wound Heal

Intervention

Procedure:
• Anterior Cervical Decompression and Fusion
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.
• Vertical Platysma Incision
A vertical platysma Incision will be used for the anterior cervical decompression and fusion surgical procedure
• Transverse Platysma Incision
A transverse platysma incision will be used for the anterior cervical decompression and fusion surgical procedure

Locations

Country	Name	City	State
United States	Boston Medical Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boston Medical Center

Country where clinical trial is conducted

United States, 

References & 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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