AlloMend Acellular Dermal Matrix Allograft in Pre-Pectoral Breast Reconstruction
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorAlloSource
About this trial
This is a single-center, retrospective study which will be used to describe and evaluate the effectiveness of AlloMend® Acellular Dermal Matrix allograft for patients that have undergone Pre-Pectoral Breast Reconstruction surgery following a single or double mastectomy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosed by a physician and required a single or double mastectomy followed by Pre-Pectoral Breast Reconstruction surgery with the use of AlloMend® Acellular Dermal Matrix allograft;
Surgical intervention using AlloMend® Acellular Dermal Matrix allograft was used;
Has completed or will complete the anticipated clinically indicated follow-up visits at 2 weeks, 6 weeks, 3 months, and 6 months post-surgical intervention.
Disqualifiers
Did not utilize AlloMend® Acellular Dermal Matrix allograft during pre-pectoral breast reconstruction
Did not have post-operative evaluations at the clinical site.
Trial population
All patients who require a single or double mastectomy and have undergone a Pre-Pectoral Breast Reconstruction surgery with the use of AlloMend® Acellular Dermal Matrix allograft are eligible to participate. Patients who meet all of the inclusion criteria but do not meet any of the exclusion criteria are eligible to enter the study.
Trial design
Design model
Case-only
Time perspective
Retrospective
Treatments tested in this trial
AlloMend® Acellular Dermal Matrix allograft
Other interventionAlloSource, a non-profit supplier of allografts and one of the nation's leading tissue banks, introduced AlloMend® Acellular Dermal Matrix allograft to bring the benefits of regenerative medicine to more patients. cellular allograft matrices, unlike synthetic materials or xenografts, are recognized as human tissue by the body for graft incorporation by the recipient, minimizing the risk of inflammation or rejection. AlloMend® Acellular Dermal Matrix allograft has been shown to incorporate into the surgical site and demonstrates blood vessel infiltration.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Descriptive Data Collection
The primary objective is to obtain descriptive data and surgical intervention and post operative surgical outcome data on AlloMend® Acellular Dermal Matrix allograft for patients that have undergone Pre-Pectoral Breast Reconstruction surgery following a single or double mastectomy.
Time frame
Up to 6- months post-operativelySecondary outcomes
1
Physical Function and Quality of Life
Secondary Objectives will identify changes in physical function and quality of life as assessed for a period of 6-months post-operatively.
Time frame
Up to 6- months post-operativelyOther outcomes
1
Qualitative Data
Qualitative data such as return to wound healing, pain, discomfort, physicial deformity, and revision surgeries will also be collected.
Time frame
Up to 6- months post-operatively Source ClinicalTrials.gov