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

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ClinicalTrials.gov Identifier: NCT03195322
Recruitment Status : Recruiting
First Posted : June 22, 2017
Last Update Posted : March 11, 2019
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Postoperative Pain Postoperative Nausea and Vomiting Quality of Life Breast Cancer Breast Prosthesis; Pain Procedure: Pre-pectoral Tissue Expander Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Use of Complete AlloDerm® Coverage in Two-stage Tissue Expansion and Implant Placement in the Subcutaneous (Pre-pectoral) Plane: a Prospective Pilot
Actual Study Start Date : October 1, 2017
Estimated Primary Completion Date : November 1, 2019
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine


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.




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


Secondary Outcome Measures :
  1. Evaluation of Postoperative Dynamic Pain Score in patients receiving pre-pectoral Tissue Expander placement for Breast Reconstruction using VAS [ Time Frame: Day 1, Day 2, Day 3, Day 7, Day 30, and Day 60 ]
    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.

  2. Evaluation of Postoperative Static Pain Score in patients receiving pre-pectoral Tissue Expander placement for Breast Reconstruction using VAS [ Time Frame: Day 2, Day 3, Day 7, Day 30, and Day 60 ]
    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.

  3. Evaluation of Postoperative Static Pain Score in patients receiving pre-pectoral Tissue Expander placement for Breast Reconstruction using "BPI-SF" questionnaire [ Time Frame: Day 1, Day 2, Day 3, Day 7, Day 30, and Day 60 ]
    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.

  4. Level of Postoperative opioid use after Mastectomy and Tissue Expander [ Time Frame: Day 1, Day 2, Day 3, Day 7, Day 30, and Day 60 ]
    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.

  5. Number of participants with postoperative vomiting after Mastectomy and Tissue Expander placement using the PONV Intensity Scale [ Time Frame: Day 1, Day 2, Day 3, Day 7, Day 30, and Day 60 ]
    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.

  6. Number of participants with postoperative nausea after Mastectomy and Tissue Expander placement using the PONV Intensity Scale [ Time Frame: Day 1, Day 2, Day 3, Day 7, Day 30, and Day 60 ]
    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.

  7. Evaluation of Postoperative Quality of Life scores of patients receiving tissue expander placement by using Breast-Q questionnaire [ Time Frame: Day 30 ]
    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.

  8. Evaluation of Changes in Postoperative Quality of Life scores of patients receiving tissue expander placement by using Breast-Q questionnaire [ Time Frame: Baseline and Day 30 ]
    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.

  9. Evaluation of Postoperative Quality of Life scores of patients receiving tissue expander placement by using SF-36 questionnaire [ Time Frame: Day 7, Day 30 ]
    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.

  10. Evaluation of Changes in Postoperative Quality of Life scores of patients receiving tissue expander placement by using SF-36 questionnaire [ Time Frame: Day 7, Day 30 ]
    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.

  11. 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 [ Time Frame: Day 1, Day 2, Day 3, Day 7, Day 30, and Day 60 ]
    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.

  12. Level of Postoperative opioid use after final breast reconstruction [ Time Frame: Day 1, Day 2, Day 3, Day 7, Day 30, and Day 60 after final 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.

  13. Number of participants with postoperative vomiting after final breast reconstruction using the PONV Intensity Scale [ Time Frame: Day 1, Day 2, Day 3, Day 7, Day 30, and Day 60 after final reconstruction ]
    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.

  14. Number of participants with postoperative nausea after final breast reconstruction using the PONV Intensity Scale [ Time Frame: Day 1, Day 2, Day 3, Day 7, Day 30, and Day 60 after final reconstruction ]
    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

  15. Evaluation of Postoperative Quality of Life scores of patients receiving final breast reconstruction with permanent implant by using Breast-Q questionnaire [ Time Frame: Day 30, 60 ]
    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.

  16. Evaluation of Changes in Postoperative Quality of Life scores of patients receiving final breast reconstruction by using Breast-Q questionnaire [ Time Frame: Day 30, 60 ]
    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.

  17. Evaluation of Postoperative Quality of Life scores of patients receiving final breast reconstruction by using SF-36 questionnaire [ Time Frame: Day 7, Day 30, Day 60 ]
    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.

  18. Evaluation of Changes in Postoperative Quality of Life scores of patients receiving final breast reconstruction by using SF-36 questionnaire [ Time Frame: Day 7-60 ]
    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.

  19. Number of participants with any postoperative complication following final breast reconstruction based on the Common Terminology Criteria for Adverse Events (CTCAE) v4.0 [ Time Frame: Day 1, Day 2, Day 3, Day 7, Day 30, and Day 60 after final reconstruction ]
    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.

  20. Number of participants with postoperative breast animation deformity assessed by Spear grading system and "VECTRA XT 3D" [ Time Frame: Day 7, Day 30, Day 60 ]
    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

  21. Evaluation of Hospital Length of Stay after final reconstruction in days [ Time Frame: Day 1-3 ]
    Hospital Length of Stay in days after final reconstruction with permanent implant will be assessed and recorder by reviewing patients' chart

  22. Evaluation of Postoperative Static Pain Score in patients receiving final Breast Reconstruction using Visual Analog Scale (VAS) [ Time Frame: Day 1, Day 2, Day 3, Day 7, Day 30, and Day 60 after final reconstruction ]
    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.

  23. Evaluation of Postoperative Dynamic Pain Score in patients receiving final Breast Reconstruction using Visual Analog Scale (VAS) [ Time Frame: Day 1, Day 2, Day 3, Day 7, Day 30, and Day 60 after final reconstruction ]
    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.

  24. Evaluation of Postoperative Static Pain Score in patients receiving final Breast Reconstruction using BPI-SF [ Time Frame: Day 1, Day 2, Day 3, Day 7, Day 30, and Day 60 after final reconstruction ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03195322


Contacts
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Contact: Charalampos Siotos, MD (410)-955-7566 csiotos1@jhmi.edu
Contact: Carisa M Cooney, MPH (443)-287-4629 ccooney3@jhmi.edu

Locations
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United States, Maryland
The Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21287
Contact: Charalampos Siotos, MD    410-955-7566    csiotos1@jhmi.edu   
Contact: Carisa M Cooney, MPH    (443)-287-4629    ccooney3@jhmi.edu   
Principal Investigator: Gedge D Rosson, MD         
Sponsors and Collaborators
Johns Hopkins University
Investigators
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Principal Investigator: Gedge D Rosson, MD Johns Hopkins University

Publications:
American Cancer Society. Breast Cancer Facts and Figures 2015-2016. http://www.cancer.org. Accessed November 5, 2015.
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
Optum, Inc. SF-36v2 Health Survey [Internet]. US; 2016 [cited 2016 Apr 19]. Available from: https://www.optum.com/optum-outcomes/what-we-do/health-surveys/sf-36v2-health-survey.html
Cleeland C. Brief Pain Inventory User Guide. Houston: University of Texas M. D. Anderson Cancer Center; 2009.

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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT03195322     History of Changes
Other Study ID Numbers: NA_00091477
First Posted: June 22, 2017    Key Record Dates
Last Update Posted: March 11, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: At the moment, there is no plan to share Individual Participant Data (IPD)

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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

Keywords provided by Johns Hopkins University:
Immediate Breast Reconstruction
Pain Control
Post Mastectomy Pain Control
Acellular Dermal Matrix

Additional relevant MeSH terms:
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Pain, Postoperative
Vomiting
Postoperative Nausea and Vomiting
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Signs and Symptoms, Digestive
Nausea