Thyroid DiseasePlatysmaNCT02951000
Platysma Trial - Platysma Suturing Versus no Sutures for Wound Closure After Primary Thyroid Surgery
A study testing platysma suture and no platysma suture in people with Thyroid Disease, run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
Influence of the platysma suture on postoperative pain and wound healing. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Thyroid Disease
- What is being tested?
- platysma suture and no platysma suture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2016to Jun 2017
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- primary thyroid surgery
Who cannot join
- previous neck surgery
- application of wound drainages
- preoperative diagnosed malignancy
- surgical extension beyond thyroid resection (e.g. lymphadenectomy)
- preexisting coagulopathy
- preexisting chronic pain syndromes
Show all 9Show fewer
- preexisting dependency on pain reliefs
- preexisting disorders in wound healing (e.g. diabetes mellitus)
- intolerance to any study medication
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Platysma Trial - a Randomized Controlled Trial of Platysma Suturing Versus no Sutures for Wound Closure After Primary Thyroid Surgery
Influence of the platysma suture on postoperative pain and wound healing.
Read the detailed description
Does a running platysma suture after primary thyroid resection alter direct postoperative pain, wound healing and long term cosmetic results.
Primary outcome measure is if the lack of a platysma-Suture decreases the postoperative pain (detected by the visual pain score 0-10) and reduces the pain medication (detected by the cumulative NSAID and opioid treatment per patient). The second Question to be answered is if the cosmetic scar result (detected by the Patient and Observer Scar Assessment Score) 6 month after thyroidectomy is better in the intervention group (no Platysma-Suture) or not.
- Conditions
- Thyroid Disease
- Being tested
- platysma suture, no platysma suture
- Keywords
- thyroidectomy, postoperative pain, wound healing
- Medical subject headings
- Thyroid Diseases, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
platysma sutureProcedure or surgery
no platysma sutureProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| platysma suture | Active comparator | running suture of the platysma with 3/0 polyglactin Receives: Procedure: platysma suture |
| no platysma suture | Active comparator | no platysma suture Receives: Procedure: no platysma suture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain
visual analogue pain scale (0-10)
Measured: Pain at morning of the first postoperative day
Secondary outcomes (5)
wound infection
wound infections needing antibiotics or reintervention
Measured: within 14 days postoperative
scar cosmesis
scar cosmesis according to patient and observer scar assessment scale (POSAS)
Measured: 6 months after surgery
Postoperative Pain
visual analogue pain scale (0-10)
Measured: Pain 6h after surgery, at the morning of the second postoperative day, 14 days after surgery
Cervical Seroma/Hematoma
clinical apparent swelling verified by ultrasound
Measured: 14 days after surgery
Disorders of the functional anatomy of the neck
New onset of clinically described swallowing problems and reduced depression of the corners of the mouth
Measured: At six months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2016 (estimated)
- Study startFeb 2016
- Primary completionNov 2016
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Thyroid DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe sponsor's other registered studies.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sven Müller, MD, Principal investigator, University Tuebigen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02951000
- Sponsor's protocol ID
- PLA1
- Acronym
- Platysma
- Status last verified
- Oct 2016
- First submitted
- 28 Oct 2016
- Last updated
- 6 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Senne M, Zein R, Falch C, Kirschniak A, Koenigsrainer A, Muller S. Randomized clinical trial of platysma muscle suture versus no suture for wound closure after thyroid surgery. Br J Surg. 2018 May;105(6):645-649. doi: 10.1002/bjs.10829. Epub 2018 Mar 26.
PubMed 29579320
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Platysma Trial - a Randomized Controlled Trial of Platysma Suturing Versus no Sutures for Wound Closure After Primary Thyroid Surgery
- ClinicalTrials.gov ID
- NCT02951000
- Acronym / sponsor ID
- Platysma / PLA1
- Conditions
- Thyroid Disease
- Keywords
- thyroidectomy, postoperative pain, wound healing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- Feb 2016 (actual)
- Primary completion
- Nov 2016 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 1 Nov 2016 (estimated)
- 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.
Influence of the platysma suture on postoperative pain and wound healing.
Detailed description
Does a running platysma suture after primary thyroid resection alter direct postoperative pain, wound healing and long term cosmetic results.
Primary outcome measure is if the lack of a platysma-Suture decreases the postoperative pain (detected by the visual pain score 0-10) and reduces the pain medication (detected by the cumulative NSAID and opioid treatment per patient). The second Question to be answered is if the cosmetic scar result (detected by the Patient and Observer Scar Assessment Score) 6 month after thyroidectomy is better in the intervention group (no Platysma-Suture) or not.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| platysma suture | Active comparator | Procedure: platysma suturerunning suture of the platysma with 3/0 polyglactin |
| no platysma suture | Active comparator | Procedure: no platysma sutureno platysma suture |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- primary thyroid surgery
Key exclusion criteria (9 listed)
- previous neck surgery
- application of wound drainages
- preoperative diagnosed malignancy
- surgical extension beyond thyroid resection (e.g. lymphadenectomy)
- preexisting coagulopathy
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 |
|---|---|---|
| platysma suture | Procedure or surgery | platysma suture |
| no platysma suture | Procedure or surgery | no platysma suture |
Primary outcome
Postoperative Pain
Time frame: Pain at morning of the first postoperative day
visual analogue pain scale (0-10)
5 secondary outcomes
wound infection
Time frame: within 14 days postoperative
scar cosmesis
Time frame: 6 months after surgery
Postoperative Pain
Time frame: Pain 6h after surgery, at the morning of the second postoperative day, 14 days after surgery
Cervical Seroma/Hematoma
Time frame: 14 days after surgery
Disorders of the functional anatomy of the neck
Time frame: At six months postoperative
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 6 Oct 2017.
- Derived from this study: PubMed 29579320Senne M, Zein R, Falch C, Kirschniak A, Koenigsrainer A, Muller S. Randomized clinical trial of platysma muscle suture versus no suture for wound closure after thyroid surgery. Br J Surg. 2018 May;105(6):645-649. doi: 10.1002/bjs.10829. Epub 2018 Mar 26.
- Individual participant dataSharing planned: Undecided
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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.
Sven Müller, MD principal investigator
University Tuebigen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing platysma suture and no platysma suture in people with Thyroid Disease, run by University Hospital Tuebingen at 1 site in Germany.
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 9 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 6 Oct 2017. 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 Germany. 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?
Postoperative Pain (time frame: Pain at morning of the first postoperative day). 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 NCT02951000, which also lists 1 linked publication.
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 6 Oct 2017.