Tissue Expansion in Breast Reconstruction Without Drains

Breast Cancer Clinical Trial

Official title:

Tissue Expansion in Breast Reconstruction Without Drains: A Study Using a Tissue Expander That Collects Periprosthetic Fluid

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03784859
• Other study ID #: Pro00052823
• Status: Completed
• Start date: February 25, 2019
• Est. completion date: October 2, 2020

Study information

• Verified date: October 2020
• Source: Cedars-Sinai Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Patients electing to have staged, implant-based, bilateral breast reconstruction at the time of mastectomy (for either cancer or cancer prevention) will undergo a standardized subpectoral tissue expander placement (using the Sientra AlloX2 dual-port device) on each side of the chest with a single piece of acellular dermal matrix (ADM). A single drain in the subcutaneous pocket of each breast will be used and removed on the first post-operative day. Patients will be admitted for overnight observation in the hospital. Each post-operative day fluid will be aspirated from each reservoir port using a standard sterile technique, and the volume recorded. After discharge, patients will be seen in the office within one week of discharge and fluid aspirated from each expander using the reservoir ports, and the volume shall be recorded. The aspiration will be repeated weekly until expansion is completed and/or the amount of fluid aspirated is less than 10 cc.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: October 2, 2020
• Est. primary completion date: July 13, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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)

Related Conditions & MeSH terms

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

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	Cedars-Sinai Medical Center	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
Cedars-Sinai Medical Center	Sientra, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (13)

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. — View Citation

Jordan SW, Khavanin N, Kim JY. Seroma in Prosthetic Breast Reconstruction. Plast Reconstr Surg. 2016 Apr;137(4):1104-16. doi: 10.1097/01.prs.0000481102.24444.72. Review. — View Citation

Kim JY, 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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