Platysma Incision Cosmesis

July 5, 2020 updated by: Boston Medical Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Boston Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vertical Platysma Incision
Patients in this arm who have anterior cervical decompression and fusion will receive the vertical platysma incision.
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.
Procedure: Vertical Platysma Incision
A vertical platysma Incision will be used for the anterior cervical decompression and fusion surgical procedure
Experimental: Transverse Platysma Incision
Patients in this arm who have anterior cervical decompression and fusion will receive the transverse platysma incision.
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.
Procedure: Transverse Platysma Incision
A transverse platysma incision will be used for the anterior cervical decompression and fusion surgical procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Modified version of the Hollander wound evaluation scale
Time Frame: 2 week follow up visit
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
Time Frame: 3 months follow up visit
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
Time Frame: 6 months follow up visit
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
Time Frame: 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
1 year follow up visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Medical Center

Investigators

  • Study Chair: Chadi Tannoury, MD, Boston Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 26, 2018

Primary Completion (Actual)

September 15, 2019

Study Completion (Actual)

September 15, 2019

Study Registration Dates

First Submitted

November 3, 2017

First Submitted That Met QC Criteria

November 8, 2017

First Posted (Actual)

November 9, 2017

Study Record Updates

Last Update Posted (Actual)

July 7, 2020

Last Update Submitted That Met QC Criteria

July 5, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • H-36610

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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