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| Name | Class |
|---|---|
| HEMOSQUID | UNKNOWN |
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The long-term objective of this study is to prove:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vacuum device surgery | Experimental | At first the surgeon proceed to the dissection of children tonsils and at last he uses the innovative vacuum device to obtain wounds hemostasis |
|
| Conventional surgery | Active Comparator | At first the surgeon proceed to the dissection of children tonsils and at last he uses a bipolar forceps to obtain wounds hemostasis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vacuum device | Device |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of cauterization time to obtain the tonsillectomy wounds hemostasis using bipolar forceps between conventional surgery group and the vacuum device group | Cauterization time (seconds) needed to obtain wounds tonsillectomy hemostasis using bipolar forceps(electric power of 20W) | From the beginning to the end of a tonsillectomy: an expected average of 2 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of the vacuum device hemostatic technique at his installation on the wound |
| From the beginning to the end of a tonsillectomy: an expected average of 2 hours |
| Assessment between two arm of the postoperative pain until 10 days after the surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sébastien Schmerber, MD,PhD | Contact | Echipon@chu-grenoble.fr | ||
| Alexandre Moreau-Gaudry, MD, PhD | Contact | Echipon@chu-grenoble.fr |
| Name | Affiliation | Role |
|---|---|---|
| Sébastien Schmerber, MD, PhD | University Hospital, Grenoble | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital, Grenoble | Recruiting | Grenoble | Isère | 38043 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21075003 | Background | Guerrero K, Moreau-Gaudry A, Porcu P, Blin D. An innovative technique to control bleeding with vacuum device. Eur J Cardiothorac Surg. 2011 Jun;39(6):1070-2. doi: 10.1016/j.ejcts.2010.09.047. Epub 2010 Nov 12. | |
| 22334630 | Background | Brichon PY, Porcu P, Moreau-Gaudry A, Blin D. Extraction of substernal goitre using an innovative vacuum device. Eur J Cardiothorac Surg. 2012 Jul;42(1):178-9. doi: 10.1093/ejcts/ezs018. Epub 2012 Feb 13. |
| Label | URL |
|---|---|
| Website of the Grenoble clinical investigation center - Technological Innovation | View source |
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| Conventional surgery |
| Procedure |
|
Pain score every day (FLACC -> children between 3 and 7 years old Faces pain scale -> children between 8 and 10 years old) |
| 10 days |
| Comparison of the time of the first complaint of pain after surgery between conventional surgery group and the vacuum device group | Time between general anesthesia and first complaint of pain | Time between general anesthesia and discharge hospitalization: an average of one day |
| Comparison of surgery time between the 2 arm | Time between the first incision and final wounds hemostasis verification | An expected average of 2 hours |
| Comparison between the 2 arms of re-feeding without pain (liquids,semi-liquids ands solids) | Time or/and day of the first meal without pain | Until 11 days after surgery |
| Comparison between the 2 arms of the number of primary hemorrhages | Number of primary hemorrhages | Until 24 hours after surgery |
| Comparison between the 2 arms of the number of secondary hemorrhages | Number of secondary hemorrhages | From 24 hours after surgery until 11 days after surgery |
| Comparison between the 2 arms of the number of rehospitalisation (all circumstances) | Number of rehospitalisation | From 24 hours after surgery until 11 days after surgery |
| Comparison between the 2 arms of the number of strong analgesics doses | Number of strong analgesics doses per day. Strong analgesics are used only if the child has a FLACC score higher than 3 (children from 3 to 7 years old) and a Faces Pain Scale score higher than 4 (children from 8 to 10 years old). | Until 11 days after surgery |
| Clinician evaluation about the feasibility of the vacuum device installation | Score from a qualitative satisfaction scale | From the beginning to the end of a tonsillectomy: an expected average of 2 hours |
| 22566511 | Background | Porcu P, Moreau-Gaudry A, Chavanon O, Blin D. Haemostasis of a right ventricle-gunshot wound using a novel haemostatic vacuum device. Interact Cardiovasc Thorac Surg. 2012 Aug;15(2):294-6. doi: 10.1093/icvts/ivs103. Epub 2012 May 7. |
| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| D011183 | Postoperative Complications |
| D010146 | Pain |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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