Implant of acellular NAC graft for Breast

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Breast+1 More
Regenerative post mastectomy surgery - Procedure
Eligibility
18+
Female
What conditions do you have?
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Study Summary

To evaluate the wound healing response following nipple-areolar complex (NAC) reconstruction with a decellularized donor NAC graft (DCLNAC)

Eligible Conditions
  • Breast

Treatment Effectiveness

Study Objectives

7 Primary · 3 Secondary · Reporting Duration: 12 months

12 months
Evaluate patient satisfaction and well-being preoperatively and serially
Nipple projection
Nipple sensitivity up to 12 months
Operative time in minutes
Physician Preference and Impressions
Vascularization by presence of bleeding
3 months
Healing of the nipple (VAS=Visual Analog Scale) dehiscence
Healing of the nipple (VAS=Visual Analog Scale) epithelialization
Healing of the nipple (VAS=Visual Analog Scale) granulation
Healing of the nipple (VAS=Visual Analog Scale) ischemia/necrosis
Healing of the nipple (VAS=Visual Analog Scale) overall healing
Healing of the nipple (infection) A. no infection B. hyperemia (no infection) C. cellulitis (superficial infection D. abscess or purulent infection
Time to complete healing (graft >99% re-epithelialized)

Trial Safety

Trial Design

1 Treatment Group

Implant of acellular NAC graft
1 of 1

Experimental Treatment

36 Total Participants · 1 Treatment Group

Primary Treatment: Implant of acellular NAC graft · No Placebo Group · N/A

Implant of acellular NAC graft
Procedure
Experimental Group · 1 Intervention: Regenerative post mastectomy surgery · Intervention Types: Procedure

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 12 months

Who is running the clinical trial?

BioAestheticsLead Sponsor
Roger Morgan, MDStudy ChairMedSurgPI, LLC

Eligibility Criteria

Age 18+ · Female Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Subjects must be able to provide written informed consent to the study procedures and for use of protected health information [HIPAA, if applicable].
Patient has undergone a bilateral autologous breast reconstruction a minimum of 3 months prior to enrollment in the study.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 7th, 2021

Last Reviewed: November 1st, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.