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Influence of the platysma suture on postoperative pain and wound healing.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| platysma suture | Active Comparator | running suture of the platysma with 3/0 polyglactin |
|
| no platysma suture | Active Comparator | no platysma suture |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| platysma suture | Procedure |
| ||
| no platysma suture |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Pain | visual analogue pain scale (0-10) | Pain at morning of the first postoperative day |
| Measure | Description | Time Frame |
|---|---|---|
| wound infection | wound infections needing antibiotics or reintervention | within 14 days postoperative |
| scar cosmesis | scar cosmesis according to patient and observer scar assessment scale (POSAS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sven Müller, MD | University Tuebigen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Tuebingen | Tübingen | 72076 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29579320 | Derived | 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. |
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| ID | Term |
|---|---|
| D013959 | Thyroid Diseases |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D004700 | Endocrine System Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
| 6 months after surgery |
| Postoperative Pain | visual analogue pain scale (0-10) | 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 | 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 | At six months postoperative |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |