Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a NA study that has completed, run by Boston Medical Center. The registered enrollment target is 22 participants.
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
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03338608
The ClinicalTrials.gov registry entry for NCT03338608 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 22 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boston Medical Center, which has 253 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Anterior Cervical Decompression and Fusion is the first listed.
NCT03338608 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.