Tissue Expansion in Breast Reconstruction Without Drains
NCT ID: NCT03784859
Last Updated: 2020-10-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
5 participants
OBSERVATIONAL
2019-02-25
2020-10-02
Brief Summary
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Detailed Description
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Patients will be asked to complete a 7 item multiple-choice questionnaire regarding their attitudes about their breast reconstruction, first at completion of tissue expansion and finally at their first follow-up visit following placement of permanent breast implants.
This study utilizes FDA 510k-classified devices that allow removal of fluid without drains, in lieu of more conventional expanders, allowing for the avoidance of prolonged drain usage.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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All patients in study
5 consecutive patients with breast cancer or a breast cancer-causing gene that elect to undergo bilateral breast reconstruction will be Insertion of Tissue Expander with Fluid Reservoir as the first stage of reconstruction. Post-surgical care will be similar as patients with conventional expanders, except that during office visits, fluid will be transcutaneously aspirated from the fluid reservoir on each side.
Insertion of Tissue Expander with Fluid Reservoir
Use of unique expander type in first stage of a two-stage breast reconstruction, without prolonged drain placement.
Interventions
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Insertion of Tissue Expander with Fluid Reservoir
Use of unique expander type in first stage of a two-stage breast reconstruction, without prolonged drain placement.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Non-smokers
* BMI less than 31
* No other significant surgical risk factors that make elective use of implants dangerous (e.g., presence of a pacemaker, frail health, dependence on blood thinners, uncontrolled diabetes, bleeding tendencies, autoimmune disorders, immune compromise)
Exclusion Criteria
* Current smokers
* Those with bleeding dyscrasias or clotting disorders
* Those who have had or will have a full axillary lymph node dissection
* Cases where there is an unusually high degree of bleeding intra-operatively (more than 150 cc)
* Those with a BMI greater than 30
* Those with history of prior breast surgery (aside from lumpectomy or needle biopsy)
* Those with a history of prior breast radiation
* Those with stage IV or unresectable breast cancer
* Significant surgical risk factors that make elective use of implants dangerous (e.g., presence of a pacemaker, frail health, dependence on blood thinners, uncontrolled diabetes, bleeding tendencies, autoimmune disorders, immune compromise)
21 Years
FEMALE
No
Sponsors
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Tiger Biosciences, LLC.
INDUSTRY
Cedars-Sinai Medical Center
OTHER
Responsible Party
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Edward Ray
Staff Physician II
Principal Investigators
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Edward C Ray, MD
Role: PRINCIPAL_INVESTIGATOR
Cedars-Sinai Medical Center
Locations
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Cedars-Sinai Medical Center
Los Angeles, California, United States
Countries
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References
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Smith JM, Broyles JM, Guo Y, Tuffaha SH, Mathes D, Sacks JM. Human acellular dermis increases surgical site infection and overall complication profile when compared with submuscular breast reconstruction: An updated meta-analysis incorporating new productsâ°. J Plast Reconstr Aesthet Surg. 2018 Nov;71(11):1547-1556. doi: 10.1016/j.bjps.2018.06.012. Epub 2018 Jul 6.
Kim JYS, Davila AA, Persing S, Connor CM, Jovanovic B, Khan SA, Fine N, Rawlani V. A meta-analysis of human acellular dermis and submuscular tissue expander breast reconstruction. Plast Reconstr Surg. 2012 Jan;129(1):28-41. doi: 10.1097/PRS.0b013e3182361fd6.
Ollech CJ, Block LM, Afifi AM, Poore SO. Effect of Drain Placement on Infection, Seroma, and Return to Operating Room in Expander-Based Breast Reconstruction. Ann Plast Surg. 2017 Dec;79(6):536-540. doi: 10.1097/SAP.0000000000001174.
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.
Sampathraju S, Rodrigues G. Seroma formation after mastectomy: pathogenesis and prevention. Indian J Surg Oncol. 2010 Dec;1(4):328-33. doi: 10.1007/s13193-011-0067-5. Epub 2011 Apr 2.
Murray JD, Elwood ET, Jones GE, Barrick R, Feng J. Decreasing expander breast infection: A new drain care protocol. Can J Plast Surg. 2009 Spring;17(1):17-21.
Carcoforo P, Soliani G, Maestroni U, Donini A, Inderbitzin D, Hui TT, Lefor A, Avital I, Navarra G. Octreotide in the treatment of lymphorrhea after axillary node dissection: a prospective randomized controlled trial. J Am Coll Surg. 2003 Mar;196(3):365-9. doi: 10.1016/S1072-7515(02)01757-X.
Park JE, Nigam M, Shenaq DS, Song DH. A simple, safe technique for thorough seroma evacuation in the outpatient setting. Plast Reconstr Surg Glob Open. 2014 Oct 7;2(9):e212. doi: 10.1097/GOX.0000000000000179. eCollection 2014 Sep.
Puttawibul P, Sangthong B, Maipang T, Sampao S, Uttamakul P, Apakupakul N. Mastectomy without drain at pectoral area: a randomized controlled trial. J Med Assoc Thai. 2003 Apr;86(4):325-31.
Rose JF, Zafar SN, Ellsworth Iv WA. Does Acellular Dermal Matrix Thickness Affect Complication Rate in Tissue Expander Based Breast Reconstruction? Plast Surg Int. 2016;2016:2867097. doi: 10.1155/2016/2867097. Epub 2016 Apr 12.
Zeidler KR, Capizzi PJ, Pittman TA. Sientra AlloX2 Short-Term Case Study, Surgical Pearls, and Roundtable Discussion. Plast Reconstr Surg. 2018 Apr;141(4S Sientra Shaped and Round Cohesive Gel Implants):29S-39S. doi: 10.1097/PRS.0000000000004352.
Moyer KE, Potochny JD. Technique for seroma drainage in implant-based breast reconstruction. J Plast Reconstr Aesthet Surg. 2012 Dec;65(12):1614-7. doi: 10.1016/j.bjps.2012.06.016. Epub 2012 Jul 6.
Jordan SW, Khavanin N, Kim JYS. Seroma in Prosthetic Breast Reconstruction. Plast Reconstr Surg. 2016 Apr;137(4):1104-1116. doi: 10.1097/01.prs.0000481102.24444.72.
Other Identifiers
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Pro00052823
Identifier Type: -
Identifier Source: org_study_id
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