Wound HealNCT03338608
Platysma Incision Cosmesis
A study testing Anterior Cervical Decompression and Fusion, Vertical Platysma Incision and Transverse Platysma Incision in people with Wound Heal, run by Boston Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Wound Heal
- What is being tested?
- Anterior Cervical Decompression and Fusion, Vertical Platysma Incision and Transverse Platysma Incision
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Nov 2018to 15 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Wound Heal
- Being tested
- Anterior Cervical Decompression and Fusion, Vertical Platysma Incision, Transverse Platysma Incision
- Keywords
- Cosmesis, Wound Healing, Anterior Cervical Decompression and Fusion, ACDF, Platysma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anterior Cervical Decompression and FusionProcedure or surgery
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 IncisionProcedure or surgery
A vertical platysma Incision will be used for the anterior cervical decompression and fusion surgical procedure
Transverse Platysma IncisionProcedure or surgery
A transverse platysma incision will be used for the anterior cervical decompression and fusion surgical procedure
| Study group | Role | What they receive |
|---|---|---|
| Vertical Platysma Incision | Experimental | Patients in this arm who have anterior cervical decompression and fusion will receive the vertical platysma incision. Receives: 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. Receives: Procedure: Anterior Cervical Decompression and Fusion; Procedure: Transverse Platysma Incision |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 1 year follow up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2017
- Study start26 Nov 2018
- Primary completion15 Sep 2019
- Study completion15 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Wound HealStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- There are two groups. One group will have the vertical platysma incision and the other group will have the transverse incision.
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chadi Tannoury, MD, Study chair, Boston Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03338608
- Sponsor's protocol ID
- H-36610
- Status last verified
- Jul 2020
- First submitted
- 3 Nov 2017
- Last updated
- 7 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 21213087Fransen 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.
PubMed 20973364Fehlings 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.
PubMed 19769487
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Platysmal Incision on Cosmetic Satisfaction Outcomes in Anterior Cervical Spine Surgery Patients
- ClinicalTrials.gov ID
- NCT03338608
- Acronym / sponsor ID
- H-36610
- Conditions
- Wound Heal
- Keywords
- Cosmesis, Wound Healing, Anterior Cervical Decompression and Fusion, ACDF, Platysma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Study start
- 26 Nov 2018 (actual)
- Primary completion
- 15 Sep 2019 (actual)
- Study completion
- 15 Sep 2019 (actual)
- First posted
- 9 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- There are two groups. One group will have the vertical platysma incision and the other group will have the transverse incision.
| Arm | Type | Receives |
|---|---|---|
| Vertical Platysma Incision | Experimental | Procedure: Anterior Cervical Decompression and Fusion, Procedure: Vertical Platysma IncisionPatients in this arm who have anterior cervical decompression and fusion will receive the vertical platysma incision. |
| Transverse Platysma Incision | Experimental | Procedure: Anterior Cervical Decompression and Fusion, Procedure: Transverse Platysma IncisionPatients in this arm who have anterior cervical decompression and fusion will receive the transverse platysma incision. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anterior Cervical Decompression and FusionPatients 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 or surgery | Transverse Platysma Incision, Vertical Platysma Incision |
| Vertical Platysma IncisionA vertical platysma Incision will be used for the anterior cervical decompression and fusion surgical procedure | Procedure or surgery | Vertical Platysma Incision |
| Transverse Platysma IncisionA transverse platysma incision will be used for the anterior cervical decompression and fusion surgical procedure | Procedure or surgery | Transverse Platysma Incision |
Primary outcome
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2020.
- Background: PubMed 21213087Denaro 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.
- Background: PubMed 20973364Fransen 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.
- Background: PubMed 19769487Fehlings 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chadi Tannoury, MD study chair
Boston Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anterior Cervical Decompression and Fusion, Vertical Platysma Incision and Transverse Platysma Incision in people with Wound Heal, run by Boston Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified version of the Hollander wound evaluation scale (time frame: 2 week follow up visit). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03338608, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2020.