Histological Analysis of AlloMend® Acellular Dermal Matrix Used in Breast Implant Surgeries

Active, not recruiting

• Conditions: Breast Implant; Complications, Infection or Inflammation

• Registration Number: NCT05744414
• Lead Sponsor: AlloSource

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-2-9
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Inclusion Criteria:<br><br> - =18 years of age;<br><br> - AlloMend® Acellular Dermal Matrix used during the initial prepectoral placement of<br> tissue expanders for breast reconstruction;<br><br> - Is scheduled or will be scheduled for a procedure to exchange the tissue expander<br> for permanent breast implant;<br><br> - Can understand the requirements of the study, has provided written, informed<br> consent, and to comply with the study protocol.<br><br>Exclusion Criteria:<br><br> - Mentally compromised (e.g., being currently treated for a psychiatric disorder,<br> senile dementia, Alzheimer's disease) in a manner that would compromise his or her<br> ability to consent to participate in the clinical study;<br><br> - Subjects who, in the opinion of the investigator, would not be able or willing to<br> comply with the protocol.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
AlloMend® Acellular Dermal Matrix graft incorporation when used in a soft tissue application

Secondary Outcome Measures

Name	Time	Method
Infection rates;Seroma rates;Hematoma rates;Drain outputs and timing of drain removal;Revision surgeries