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NCT03338608 · ClinicalTrials.gov registry record · NA
Platysma Incision Cosmesis
A NA study, sponsored by Boston Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 22
- Enrollment target
NCT03338608: Completed NA study, sponsored by Boston Medical Center.
NCT03338608 is a NA study that has completed, run by Boston Medical Center. The registered enrollment target is 22 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03338608, a NA study, has completed, sponsored by Boston Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 22 participants
- Enrollment target
Study 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
Primary Outcome
Includes several factors of cosmetic wound healing (skin puckering, patient satisfaction, etc.). Based on photographic and patient follow-up information
Interventions
- PROCEDURE Anterior Cervical Decompression and Fusion
- PROCEDURE Vertical Platysma Incision
- PROCEDURE Transverse Platysma Incision
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2018-11-26 |
| Est. Completion | 2019-09-15 |
| Phase | NA |
What the finished NCT03338608 record still lists
NCT03338608 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 3 interventions - of which Anterior Cervical Decompression and Fusion is the first listed.
NCT03338608 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03338608 about?
NCT03338608 is a clinical study titled "Platysma Incision Cosmesis". 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 cos...
What is the current status of trial NCT03338608?
This trial is currently completed. It is a NA study. The enrollment target is 22 participants. The study started on 2018-11-26. Estimated completion is 2019-09-15.
What interventions are being tested in trial NCT03338608?
The interventions under investigation include: Anterior Cervical Decompression and Fusion (PROCEDURE), Vertical Platysma Incision (PROCEDURE), Transverse Platysma Incision (PROCEDURE).
Who is sponsoring clinical trial NCT03338608?
This trial is sponsored by Boston Medical Center, which has 253 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03338608's enrollment target sits among peer trials
22 1756th of 2000 higher than 239 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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