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| Name | Class |
|---|---|
| Consorci Sanitari del Maresme | OTHER |
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Axillary lymphadenectomy in breast cancer continues to be a common practice in certain patients. The use of sealants and drains continues to be a source of disagreement among the scientific community. That is why the study was designed to show whether the sealant reduces seroma after axillary lymphadenectomy without drainage.
A study has been designed to assess whether the sealant reduces the rate of symptomatic seroma measured by the number of evacuating punctures. Likewise, the decrease in volume due to the seroma between the two groups and the quality of life of the patients is assessed, given that none of them has a drain
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| lymphadenectomy without drainage and with Glubran | Experimental | Application of Glubran 2 in axillary dissection with the objective of seroma reduction. No drain |
|
| Lymphadenectomy without drainage | No Intervention | No intervention required, only axillary dissection without drain |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glubran 2 | Other | Application of Glubran 2 sealant (liquid) in axillary hollow |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in symptomatic seroma | Number of evacuating punctures | Up tp 1 year |
| Number of participants with treatment-related adverse events | Type and number of adverse events | Up to 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Seroma volume | Volume measured by ultrasound (cm3 ) | Day 7 and 14 after surgery |
| Milliliters of evacuated seroma in case of puncture | Assess if there are differences in the volume of seroma evacuated (milliliters) between groups |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sandra Lopez Gordo | Contact | 937 41 77 00 | 1141 | slopezgord@csdm.cat |
| Name | Affiliation | Role |
|---|---|---|
| Sandra Lopez Gordo, Doctor | Health Consortium Maresme | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maresme health consortium | Recruiting | Mataró | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28898379 | Background | Giuliano AE, Ballman KV, McCall L, Beitsch PD, Brennan MB, Kelemen PR, Ollila DW, Hansen NM, Whitworth PW, Blumencranz PW, Leitch AM, Saha S, Hunt KK, Morrow M. Effect of Axillary Dissection vs No Axillary Dissection on 10-Year Overall Survival Among Women With Invasive Breast Cancer and Sentinel Node Metastasis: The ACOSOG Z0011 (Alliance) Randomized Clinical Trial. JAMA. 2017 Sep 12;318(10):918-926. doi: 10.1001/jama.2017.11470. | |
| 21849243 |
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| ID | Term |
|---|---|
| C421461 | glubran 2 |
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MULTICENTRIC, PROSPECTIVE, RANDOMIZED CLINICAL TRIAL
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| 7, 14 and 30 day after surgery |
| Demographic characteristics of patients related to seroma | Assess the existence of risk factors (age, sex, obesity,neoadjuvant treatment) related to symptomatic seroma | Up to 1 year |
| Number of patients with temporary or permanence of disability after operation | Clavien-Dindo classification of morbidity | Up to 1 year |
| Individual's perception of the position in life of the participants | Assess the quality of life after the intervention measured by the EuroQol five dimensions (EQ-5D-5L questionnaire). Descriptive system for health-related quality of life states in adults, consisting of five dimensions. No quality 0 points. Perfect quality 100 points | Day 7 and 14 after surgery |
| Background |
| van Bemmel AJ, van de Velde CJ, Schmitz RF, Liefers GJ. Prevention of seroma formation after axillary dissection in breast cancer: a systematic review. Eur J Surg Oncol. 2011 Oct;37(10):829-35. doi: 10.1016/j.ejso.2011.04.012. Epub 2011 Aug 17. |
| 23346164 | Background | Srivastava V, Basu S, Shukla VK. Seroma formation after breast cancer surgery: what we have learned in the last two decades. J Breast Cancer. 2012 Dec;15(4):373-80. doi: 10.4048/jbc.2012.15.4.373. Epub 2012 Dec 31. |
| 24158902 | Background | Thomson DR, Sadideen H, Furniss D. Wound drainage after axillary dissection for carcinoma of the breast. Cochrane Database Syst Rev. 2013 Oct 20;2013(10):CD006823. doi: 10.1002/14651858.CD006823.pub2. |
| 32564232 | Background | Chang YT, Shih SL, Loh EW, Tam KW. Effects of Fibrin Sealant on Seroma Reduction for Patients with Breast Cancer Undergoing Axillary Dissection: Meta-Analysis of Randomized Controlled Trials. Ann Surg Oncol. 2020 Dec;27(13):5286-5295. doi: 10.1245/s10434-020-08747-5. Epub 2020 Jun 20. |
| 27393569 | Background | Gunn J, Gibson T, Li Z, Diehl N, Bagaria S, McLaughlin S. Symptomatic Axillary Seroma after Sentinel Lymph Node Biopsy: Incidence and Treatment. Ann Surg Oncol. 2016 Oct;23(10):3347-53. doi: 10.1245/s10434-016-5398-6. Epub 2016 Jul 8. |
| 14716794 | Background | Jain PK, Sowdi R, Anderson AD, MacFie J. Randomized clinical trial investigating the use of drains and fibrin sealant following surgery for breast cancer. Br J Surg. 2004 Jan;91(1):54-60. doi: 10.1002/bjs.4435. |
| 28673765 | Background | Vasileiadou K, Kosmidis C, Anthimidis G, Miliaras S, Kostopoulos I, Fahantidis E. Cyanoacrylate Adhesive Reduces Seroma Production After Modified Radical Mastectomy or Quadrantectomy With Lymph Node Dissection-A Prospective Randomized Clinical Trial. Clin Breast Cancer. 2017 Dec;17(8):595-600. doi: 10.1016/j.clbc.2017.04.004. Epub 2017 Apr 13. |
| 19348971 | Background | Thorpe KE, Zwarenstein M, Oxman AD, Treweek S, Furberg CD, Altman DG, Tunis S, Bergel E, Harvey I, Magid DJ, Chalkidou K. A pragmatic-explanatory continuum indicator summary (PRECIS): a tool to help trial designers. J Clin Epidemiol. 2009 May;62(5):464-75. doi: 10.1016/j.jclinepi.2008.12.011. |
| 38388444 | Derived | Lopez Gordo S, Ruiz-Edo N, Fernandez-Planas MT, Viscaya-Martin S, Serra-Serra C; Breast Cancer Research Group. Seroma control in axillary lymphadenectomy with Glubran 2(R) without drain. Multicenter, prospective, randomized, clinical trial. GALA-ND study (Glubran, Axillary Lymphadenectomy, Ambulatory, No Drain). Trials. 2024 Feb 22;25(1):142. doi: 10.1186/s13063-023-07840-w. |