Pre-pectoral AlloDerm® to Reinforce Tissues in Tissue Expander Breast Reconstruction

The Use of Complete AlloDerm® Coverage in Two-stage Tissue Expansion and Implant Placement in the Subcutaneous (Pre-pectoral) Plane: a Prospective Pilot

Primary Objective:

• 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.

Study Overview

• Status: Completed
• Conditions: Quality of Life; Breast Cancer; Postoperative Pain; Postoperative Nausea and Vomiting; Breast Prosthesis; Pain
• Intervention / Treatment: Procedure: Pre-pectoral Tissue Expander

Detailed Description

Study participants meeting inclusion criteria will be enrolled prior to surgery. Once the patient has been seen by one of the Institutional Review Board (IRB)-approved study physicians at the initial clinic visit and informed consent has been obtained, pre-study patient-reported outcome (PRO) questionnaires will be distributed and collected by one of the IRB-approved healthcare providers (i.e. medical assistant, nurse, nurse-practitioner, or plastic surgeon). These questionnaires include the Pain Visual Analog Scale, the Patient Pain Assessment Questionnaire which assesses static and dynamic pain as well as nausea and interference with sleep, the Subjective Pain Survey, the preoperative Breast-Q: Reconstruction Module, the SF-36, and the Brief Pain Inventory-Short Form. Participants will then be asked to complete a general patient history form.

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • The Johns Hopkins University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Be women, aged 18-75 years.
• 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:

• Plan to undergo final reconstruction with autologous material.
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pre-pectoral Tissue Expander; Pre-pectoral immediate tissue expander breast reconstruction with complete AlloDerm® coverage to reinforce breast tissues.	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of Postoperative Static Pain Score in patients receiving pre-pectoral Tissue Expander placement for Breast Reconstruction using Visual Analog Scale (VAS)	Postoperative static pain scores with standard deviations from VAS will be measured on post-operative (after mastectomy and tissue expander placement) at Day 1	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of Postoperative Dynamic Pain Score in patients receiving pre-pectoral Tissue Expander placement for Breast Reconstruction using VAS	Postoperative dynamic pain scores with standard deviations from VAS will be measured on post-operative (after mastectomy and tissue expander placement) Day 1, Day 2, Day 3, and Day 7, before the initiation of tissue expander expansion, and in post-operative Day 30, and Day 60 following initiation of tissue expander expansion.	Day 1, Day 2, Day 3, Day 7, Day 30, and Day 60
Evaluation of Postoperative Static Pain Score in patients receiving pre-pectoral Tissue Expander placement for Breast Reconstruction using VAS	Postoperative static pain scores with standard deviations from VAS will be measured on post-operative (after mastectomy and tissue expander placement at Day 2, Day 3, and Day 7, before the initiation of tissue expander expansion, and in post-operative Day 30, and Day 60 following initiation of tissue expander expansion.	Day 2, Day 3, Day 7, Day 30, and Day 60
Evaluation of Postoperative Static Pain Score in patients receiving pre-pectoral Tissue Expander placement for Breast Reconstruction using "BPI-SF" questionnaire	postoperative static pain scores with standard deviations from BPI-SF, will be measured on post-operative (after mastectomy and tissue expander placement) Day 1, Day 2, Day 3, and Day 7 before the initiation of tissue expander expansion, and in post-operative Day 30, and Day 60 following initiation of tissue expander expansion.	Day 1, Day 2, Day 3, Day 7, Day 30, and Day 60
Level of Postoperative opioid use after Mastectomy and Tissue Expander	Evaluation of level of opioids (type of opioids and dosage) which the patient required to alleviate the pain related to the insertion and expansion of tissue expander. Relevant information will be assessed by the patients' charts (when inpatient) and by patients' reports to study members (as an outpatient) on Day 1, Day 2, Day 3, Day, 7, Day 30, and Day 60 after mastectomy and tissue expander placement.	Day 1, Day 2, Day 3, Day 7, Day 30, and Day 60
Number of participants with postoperative vomiting after Mastectomy and Tissue Expander placement using the PONV Intensity Scale	Evaluation of number of participants who report postoperative vomiting according to the PONV Intensity Scale at Day 1, Day 2, Day 3, Day, 7, Day 30, and Day 60 after mastectomy and tissue expander placement.	Day 1, Day 2, Day 3, Day 7, Day 30, and Day 60
Number of participants with postoperative nausea after Mastectomy and Tissue Expander placement using the PONV Intensity Scale	Evaluation of number of participants who report postoperative nausea to either according the PONV Intensity Scale at Day 1, Day 2, Day 3, Day, 7, Day 30, and Day 60 after mastectomy and tissue expander placement.	Day 1, Day 2, Day 3, Day 7, Day 30, and Day 60
Evaluation of Postoperative Quality of Life scores of patients receiving tissue expander placement by using Breast-Q questionnaire	Postoperative short-term changes in Quality of Life scores by using the Breast-Q questionnaire scores, on Day 30 after mastectomy and tissue expander placement.	Day 30
Evaluation of Changes in Postoperative Quality of Life scores of patients receiving tissue expander placement by using Breast-Q questionnaire	Preoperative and postoperative (Day 30 after mastectomy and tissue expander placement) Quality of Life scores will be assessed by using the Breast-Q questionnaire scores. Changes in Quality of Life Scores will be assessed by subtracting preoperative score from the one recorded postoperative.	Baseline and Day 30
Evaluation of Postoperative Quality of Life scores of patients receiving tissue expander placement by using SF-36 questionnaire	Postoperative short-term changes in Quality of Life scores by using the SF-36 Health Survey, after mastectomy and tissue expander placement on post-operative Day 7, and Day 30.	Day 7, Day 30
Evaluation of Changes in Postoperative Quality of Life scores of patients receiving tissue expander placement by using SF-36 questionnaire	Preoperative and postoperative (Day 7, 30 after mastectomy and tissue expander placement) Quality of Life scores will be assessed by using the SF-36 Health Survey. Changes in Quality of Life Scores will be assessed by subtracting preoperative score from the ones recorded postoperative.	Day 7, Day 30
Number of participants with any postoperative complication following mastectomy and tissue expander placement based on the Common Terminology Criteria for Adverse Events (CTCAE) v4.0	Postoperative complication rates will be assessed by patients' charts at Day 1, Day 2, Day 3, Day 7, Day 30, and Day 60 after mastectomy and tissue expander placement. Number and characteristics of complications will be recorded.	Day 1, Day 2, Day 3, Day 7, Day 30, and Day 60
Level of Postoperative opioid use after final breast reconstruction	Evaluation of level of opioids (type of opioids and dosage) which the patient required to alleviate the pain related to final breast reconstruction with permanent implant. Relevant information will be assessed by the patients' charts (when inpatient) and by patients' reports to study members (as an outpatient) on Day 1, Day 2, Day 3, Day, 7, Day 30, and Day 60 after final reconstruction with permanent implant.	Day 1, Day 2, Day 3, Day 7, Day 30, and Day 60 after final reconstruction
Number of participants with postoperative vomiting after final breast reconstruction using the PONV Intensity Scale	Evaluation of number of participants who report postoperative vomiting according to the PONV Intensity Scale at Day 1, Day 2, Day 3, Day, 7, Day 30, and Day 60 after final breast reconstruction with permanent implant.	Day 1, Day 2, Day 3, Day 7, Day 30, and Day 60 after final reconstruction
Number of participants with postoperative nausea after final breast reconstruction using the PONV Intensity Scale	Evaluation of number of participants who report postoperative nausea according to the PONV Intensity Scale at Day 1, Day 2, Day 3, Day, 7, Day 30, and Day 60 after final breast reconstruction with permanent implant	Day 1, Day 2, Day 3, Day 7, Day 30, and Day 60 after final reconstruction
Evaluation of Postoperative Quality of Life scores of patients receiving final breast reconstruction with permanent implant by using Breast-Q questionnaire	Postoperative short-term changes in Quality of Life scores by using the Breast-Q questionnaire scores, on Day 30, and Day 60 after final breast reconstruction with permanent implant.	Day 30, 60
Evaluation of Changes in Postoperative Quality of Life scores of patients receiving final breast reconstruction by using Breast-Q questionnaire	Preoperative, postoperative after mastectomy and tissue expander placement and postoperative after final breast reconstruction Quality of Life scores will be assessed by using the Breast-Q questionnaire scores. Changes in Quality of Life Scores will be assessed by subtracting the most recent score from the previous one, and the most recent from the very first one.	Day 30, 60
Evaluation of Postoperative Quality of Life scores of patients receiving final breast reconstruction by using SF-36 questionnaire	Postoperative short-term changes in Quality of Life scores by using the SF-36 Health Survey, after final breast reconstruction at post-operative Day 7, Day 30, and Day 60.	Day 7, Day 30, Day 60
Evaluation of Changes in Postoperative Quality of Life scores of patients receiving final breast reconstruction by using SF-36 questionnaire	Preoperative, postoperative after mastectomy and tissue expander placement and postoperative after final breast reconstruction Quality of Life scores will be assessed by using the SF-36 Health Survey. Changes in Quality of Life Scores will be assessed by subtracting the most recent score from the previous one, and the most recent from the very first one.	Day 7-60
Number of participants with any postoperative complication following final breast reconstruction based on the Common Terminology Criteria for Adverse Events (CTCAE) v4.0	Postoperative complication rates will be assessed by patients' charts at Day 1, Day 2, Day 3, Day 7, Day 30, and Day 60 after final breast reconstruction with permanent implant. Number and characteristics of complications will be recorded.	Day 1, Day 2, Day 3, Day 7, Day 30, and Day 60 after final reconstruction
Number of participants with postoperative breast animation deformity assessed by Spear grading system and "VECTRA XT 3D"	Postoperative rates of breast animation deformity will be assessed at Day 7, Day 30, and Day 60 after final reconstruction with permanent implant, using the Spear 4-point grading system. Participants 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 7, Day 30, Day 60
Evaluation of Hospital Length of Stay after final reconstruction in days	Hospital Length of Stay in days after final reconstruction with permanent implant will be assessed and recorder by reviewing patients' chart	Day 1-3
Evaluation of Postoperative Static Pain Score in patients receiving final Breast Reconstruction using Visual Analog Scale (VAS)	Postoperative static pain scores with standard deviations from VAS will be measured on post-operative at Day 1, Day 2, Day 3, and Day 7, Day 30, and Day 60 following final breast reconstruction.	Day 1, Day 2, Day 3, Day 7, Day 30, and Day 60 after final reconstruction
Evaluation of Postoperative Dynamic Pain Score in patients receiving final Breast Reconstruction using Visual Analog Scale (VAS)	Postoperative dynamic pain scores with standard deviations from VAS will be measured on post-operative at Day 1, Day 2, Day3, and Day 7, Day 30, and Day 60 following final breast reconstruction.	Day 1, Day 2, Day 3, Day 7, Day 30, and Day 60 after final reconstruction
Evaluation of Postoperative Static Pain Score in patients receiving final Breast Reconstruction using BPI-SF	Postoperative static pain scores from BPI-SF will be measured on post-operative at Day 1, Day 2, Day3, and Day 7, Day 30, and Day 60 following final breast reconstruction.	Day 1, Day 2, Day 3, Day 7, Day 30, and Day 60 after final reconstruction

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Investigators: Principal Investigator: Gedge D Rosson, MD, Johns Hopkins University

Publications and helpful links

General Publications

• Scott J, Huskisson EC. Graphic representation of pain. Pain. 1976 Jun;2(2):175-84. No abstract available.
• Breivik H, Borchgrevink PC, Allen SM, Rosseland LA, Romundstad L, Hals EK, Kvarstein G, Stubhaug A. Assessment of pain. Br J Anaesth. 2008 Jul;101(1):17-24. doi: 10.1093/bja/aen103. Epub 2008 May 16.
• Wallace MS, Wallace AM, Lee J, Dobke MK. Pain after breast surgery: a survey of 282 women. Pain. 1996 Aug;66(2-3):195-205. doi: 10.1016/0304-3959(96)03064-3.
• 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.
• American Cancer Society. Breast Cancer Facts and Figures 2015-2016. http://www.cancer.org. Accessed November 5, 2015.
• Lucas DJ, Sabino J, Shriver CD, Pawlik TM, Singh DP, Vertrees AE. Doing more: trends in breast cancer surgery, 2005 to 2011. Am Surg. 2015 Jan;81(1):74-80.
• 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.
• Spear SL, Schwartz J, Dayan JH, Clemens MW. Outcome assessment of breast distortion following submuscular breast augmentation. Aesthetic Plast Surg. 2009 Jan;33(1):44-8. doi: 10.1007/s00266-008-9275-y. Epub 2008 Dec 4.
• 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.
• 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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Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2017
• Primary Completion (Actual): November 30, 2021
• Study Completion (Actual): December 10, 2021

Study Registration Dates

• First Submitted: April 18, 2017
• First Submitted That Met QC Criteria: June 19, 2017
• First Posted (Actual): June 22, 2017

Study Record Updates

• Last Update Posted (Actual): December 16, 2021
• Last Update Submitted That Met QC Criteria: December 15, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: Pain Control; Acellular Dermal Matrix; Immediate Breast Reconstruction; Post Mastectomy Pain Control
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Signs and Symptoms, Digestive; Nausea; Vomiting; Postoperative Nausea and Vomiting
• Other Study ID Numbers: IRB00091477

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: At the moment, there is no plan to share Individual Participant Data (IPD)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes