Pre-pectoral AlloDerm® to Reinforce Tissues in Tissue Expander Breast Reconstruction
NCT ID: NCT03195322
Last Updated: 2021-12-16
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
NA
20 participants
INTERVENTIONAL
2017-10-01
2021-12-10
Brief Summary
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• To describe postoperative static pain scores on the Pain Visual Analog Scale at Day 1 in a population of women undergoing bilateral mastectomy followed by immediate, bilateral pre-pectoral tissue expander breast reconstruction reinforced with AlloDerm® coverage.
Secondary Objectives:
* To describe postoperative static and dynamic pain scores on the Pain Visual Analog Scale and Brief Pain Inventory-Short Form at Day 1-60 after tissue expander placement
* To describe nausea/vomiting, and opioid use at Day 1, 2, 3, 7, 30, and 60 after mastectomy and tissue expander placement.
* To describe short-term changes in Quality of Life scores after mastectomy and tissue expander placement.
* To describe postoperative complication rates at Day 1, 2, 3, 7, 30, and 60 after mastectomy and tissue expander placement.
* To describe nausea/vomiting, and opioid use at Day 1, 2, 3, 7, 30, and 60 after final reconstruction with tissue expander exchange for permanent implant.
* To describe short-term changes in Quality of Life scores after final reconstruction with tissue expander exchange for permanent implant.
* To describe postoperative complication rates at Day 1, 2, 3, 7, 30, and 60 after final reconstruction with tissue expander exchange for permanent implant.
* To describe postoperative rates of breast animation deformity at Day 7, 30, and 60 after final reconstruction with tissue expander exchange for permanent implant.
* To describe average hospital length of stay in patients after final reconstruction with tissue expander exchange for permanent implant.
* To describe the patient's final assessment of pre-pectoral reconstruction from free-form text.
Tertiary Objectives:
• To measure cosmetic result and associated residual pain with Alloderm® reinforcement of breast pocket.
Detailed Description
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Patients will undergo bilateral mastectomy followed by immediate, bilateral pre-pectoral tissue expander breast reconstruction with complete AlloDerm® coverage. Patients who are determined to be poor surgical candidates intra-operatively will be excluded from the study and receive standard of care reconstruction. All patient-specific surgical details will be recorded intra-operatively. See Figure 1 for a schematic of the first stage of reconstruction: bilateral mastectomy and tissue expander placement.
Following the surgery, postoperative pain will be assessed by the Pain Visual Analog Scale (VAS), the Patient Pain Assessment Questionnaire, and the Brief Pain Inventory-Short Form (BPI-SF); pain medication/opioid use and nausea/vomiting will be assessed by the Postoperative nausea and vomiting (PONV) Intensity Scale; and adverse events (AEs)/serious adverse events (SAEs) and the occurrence of complications (seroma, hematoma, cellulitis, and infection requiring expander removal) will be assessed by staff during the hospital stay (Day 1, Day 2, Day 3) and on Day 7 (±2 days) when participants return to clinic for the first follow-up visit after mastectomy and tissue expander placement. At this visit on Day 7, an updated medical history will be completed, pain medication and opioid use will be recorded, and participant complications/AEs/SAEs assessed. In order to minimize missing data, participants will be educated by an IRB-approved member to complete all possible questionnaire items. Furthermore, in order to avoid expectancy-bias, study team members will ensure that patients complete the PRO questionnaires before meeting with study healthcare providers for all postoperative follow-up appointments. Following the completion of all assessments on Day 7, patients will undergo initiation of tissue expander expansion carefully recording the rate and volume of fill.
Longer-term quality-of-life/health outcomes assessments will be performed on postoperative Day 30 (±4 days) and Day 60 (±7 days) after the initiation of tissue expander expansion. During these visits, pain scores (Pain Visual Analog Scale, Patient Pain Assessment Questionnaire, and Brief Pain Inventory-Short Form), pain medication/opioid use, postoperative Breast-Q, and SF-36 questionnaires will be administered. Day 60 follow-up is included as a tertiary endpoint to capture differences in residual pain. Patients will be asked to complete the same questionnaires as at the Day 30 follow-up.
Following final reconstruction with tissue expander exchange for permanent implant, typically three months after mastectomy and tissue expander placement, all PRO questionnaires, postoperative static and dynamic pain, nausea/vomiting/opioid use, short-term changes in Quality of Life, complication rates, average hospital length of stay and residual pain will be assessed. Additionally, on Day 30, and Day 60 after permanent implant placement patients will be photographed comparing the breasts at rest and with pectoralis muscle flexion to assess for breast animation deformity using the Spear 4-point grading system. They will then be imaged using "VECTRA® XT 3D" digital imaging technology ("CANFIELD Scientific", Inc.) on Day 60. Differences in breast volume, surface area, shape, size, contour, and symmetry will be evaluated using the "VECTRA® XT" Analysis Module software. Day 60 follow-up is included as a tertiary endpoint to capture differences in cosmetic result and residual pain after final reconstruction. Patients will be asked to complete the same questionnaires as at the Day 30 follow-up. See Figure 2 for a schematic of the second stage of reconstruction: tissue expander exchange for permanent implant.
\*Patients will be called the morning of their Day 7, Day 30, and Day 60 appointments as a reminder. In the event they are unable to attend, every attempt will be made to reschedule within 2, 4, and 7 days, respectively.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Pre-pectoral Tissue Expander
Pre-pectoral immediate tissue expander breast reconstruction with complete AlloDerm® coverage to reinforce breast tissues.
Pre-pectoral Tissue Expander
All participants in the study will undergo bilateral mastectomy followed by Immediate, bilateral pre-pectoral tissue expander breast reconstruction with complete AlloDerm® coverage.
Interventions
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Pre-pectoral Tissue Expander
All participants in the study will undergo bilateral mastectomy followed by Immediate, bilateral pre-pectoral tissue expander breast reconstruction with complete AlloDerm® coverage.
Eligibility Criteria
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Inclusion Criteria
* Choose bilateral mastectomy (therapeutic or prophylactic) followed by immediate, bilateral pre-pectoral tissue expander breast reconstruction with complete AlloDerm® coverage.
* Have no inflammatory breast cancers.
* Be aware of the nature of her malignancy.
* Understand the study purpose, requirements, and risks.
* Be able and willing to give informed consent.
Exclusion Criteria
* Allergies to gentamicin, cefoxitin, lincomycin, vancomycin, or polymixin (antibiotics used in the pre-treatment of AlloDerm®).
* Active connective tissue disease.
* Current smokers.
* History of, or plan to undergo irradiation of the breasts.
18 Years
FEMALE
No
Sponsors
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Johns Hopkins University
OTHER
Responsible Party
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Principal Investigators
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Gedge D Rosson, MD
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins University
Locations
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The Johns Hopkins University
Baltimore, Maryland, United States
Countries
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References
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American Cancer Society. Breast Cancer Facts and Figures 2015-2016. http://www.cancer.org. Accessed November 5, 2015.
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Albornoz CR, Bach PB, Mehrara BJ, Disa JJ, Pusic AL, McCarthy CM, Cordeiro PG, Matros E. A paradigm shift in U.S. Breast reconstruction: increasing implant rates. Plast Reconstr Surg. 2013 Jan;131(1):15-23. doi: 10.1097/PRS.0b013e3182729cde.
Edsander-Nord A, Brandberg Y, Wickman M. Quality of life, patients' satisfaction, and aesthetic outcome after pedicled or free TRAM flap breast surgery. Plast Reconstr Surg. 2001 Apr 15;107(5):1142-53; discussion 1154-5. doi: 10.1097/00006534-200104150-00007.
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Harless C, Jacobson SR. Current strategies with 2-staged prosthetic breast reconstruction. Gland Surg. 2015 Jun;4(3):204-11. doi: 10.3978/j.issn.2227-684X.2015.04.22.
Susarla SM, Ganske I, Helliwell L, Morris D, Eriksson E, Chun YS. Comparison of clinical outcomes and patient satisfaction in immediate single-stage versus two-stage implant-based breast reconstruction. Plast Reconstr Surg. 2015 Jan;135(1):1e-8e. doi: 10.1097/PRS.0000000000000803.
Sbitany H, Sandeen SN, Amalfi AN, Davenport MS, Langstein HN. Acellular dermis-assisted prosthetic breast reconstruction versus complete submuscular coverage: a head-to-head comparison of outcomes. Plast Reconstr Surg. 2009 Dec;124(6):1735-1740. doi: 10.1097/PRS.0b013e3181bf803d.
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Vardanian AJ, Clayton JL, Roostaeian J, Shirvanian V, Da Lio A, Lipa JE, Crisera C, Festekjian JH. Comparison of implant-based immediate breast reconstruction with and without acellular dermal matrix. Plast Reconstr Surg. 2011 Nov;128(5):403e-410e. doi: 10.1097/PRS.0b013e31822b6637.
Reitsamer R, Peintinger F. Prepectoral implant placement and complete coverage with porcine acellular dermal matrix: a new technique for direct-to-implant breast reconstruction after nipple-sparing mastectomy. J Plast Reconstr Aesthet Surg. 2015 Feb;68(2):162-7. doi: 10.1016/j.bjps.2014.10.012. Epub 2014 Oct 16.
Lee KT, Mun GH. Updated Evidence of Acellular Dermal Matrix Use for Implant-Based Breast Reconstruction: A Meta-analysis. Ann Surg Oncol. 2016 Feb;23(2):600-10. doi: 10.1245/s10434-015-4873-9. Epub 2015 Oct 5.
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Kim MS, Sbalchiero JC, Reece GP, Miller MJ, Beahm EK, Markey MK. Assessment of breast aesthetics. Plast Reconstr Surg. 2008 Apr;121(4):186e-194e. doi: 10.1097/01.prs.0000304593.74672.b8.
LifeCell Corporation, USA. AlloDerm® Regenerative Tissue Matrix: Instructions for Use. (http://www.lifecell.com/fileadmin/media/files/downloads/Alloderm_IFU_D.pdf)
Memorial Sloan-Kettering Cancer Center. QScore Scoring Software [Internet]. US; 2012 [cited 2016 Apr 19]. Available from: https://webcore.mskcc.org/breastq/scoring.html
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Other Identifiers
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IRB00091477
Identifier Type: -
Identifier Source: org_study_id