Tissue Expansion in Breast Reconstruction Without Drains

NCT03784859 | Completed FDA Device

• 1 other identifier: Pro00052823
• Study Type: observational
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this small feasibility pilot study is to demonstrate that implant-based breast reconstruction (after treatment for cancer) can successfully be performed without prolonged drain placement, using a tissue expander with a reservoir and in-office transcutaneous fluid aspiration. Secondly, the investigators aim to provide enough confidence in this technique that a larger study can be performed to demonstrate fewer complications (infection, drain-related pain and re-operation rates) when compared to the use of conventional tissue expanders and/or implants with prolonged drain placement.

Conditions

Breast Cancer; Hereditary Breast and Ovarian Cancer Syndrome; Breast Implant; Complications

Outcome Measures

Primary Outcomes (1)

• Number of patients with successful breast reconstruction using reservoir-expanders

  The number of patients that successfully complete two stage implant-based breast reconstruction with fluid-reservoir tissue expanders and early drain removal. An outcome failure would be if the expander required removal due to uncontrolled seroma, infection or other factor that prevents a successful implant-based reconstruction.

  4-6 months

Study Arms (1)

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.

Device: Insertion of Tissue Expander with Fluid Reservoir

Interventions

Insertion of Tissue Expander with Fluid Reservoir DEVICE

Use of unique expander type in first stage of a two-stage breast reconstruction, without prolonged drain placement.

Also known as: Sientra AlloX2 Expander

All patients in study

Eligibility Criteria

• Age: 21 Years+
• Gender Eligibility Details: Female breast cancer patients are usually candidates for reconstruction using breast implants
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women over the age of 21 with breast cancer or a gene that increases the risk of breast cancer who elect to undergo bilateral mastectomies and two-stage implant-based reconstruction using tissue expanders and permanent implants.

You may qualify if:

• Patients undergoing bilateral breast reconstruction following mastectomy (performed to treat stage I-III breast cancer or for prevention of breast cancer).
• 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)

You may not qualify if:

• Unilateral mastectomy patients
• 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)

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead
• Tiger Biosciences, LLC.: collaborator

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Related Publications (13)

• 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 products✰. J Plast Reconstr Aesthet Surg. 2018 Nov;71(11):1547-1556. doi: 10.1016/j.bjps.2018.06.012. Epub 2018 Jul 6.

  PMID: 30093286 BACKGROUND

• 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.

  PMID: 22186498 BACKGROUND

• 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.

  PMID: 28671886 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.

  PMID: 23346164 BACKGROUND

• 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.

  PMID: 22693384 BACKGROUND

• 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.

  PMID: 20190908 BACKGROUND

• 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.

  PMID: 12648685 BACKGROUND

• 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.

  PMID: 25426395 BACKGROUND

• 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.

  PMID: 12757076 BACKGROUND

• 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.

  PMID: 27190645 BACKGROUND

• 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.

  PMID: 29595716 BACKGROUND

• 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.

  PMID: 22770571 BACKGROUND

• 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.

  PMID: 27018665 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms; Hereditary Breast and Ovarian Cancer Syndrome

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Ovarian Neoplasms; Endocrine Gland Neoplasms; Neoplastic Syndromes, Hereditary; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Endocrine System Diseases; Gonadal Disorders

Study Officials

• Edward C Ray, MD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Physician II

Study Record Dates

• First Submitted: December 20, 2018
• First Posted: December 24, 2018
• Study Start: February 25, 2019
• Primary Completion: July 13, 2020
• Study Completion: October 2, 2020
• Last Updated: October 6, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)