A Retrospective Breast Reconstruction Study (NCT04060134) | Clinical Trial Compass
CompletedNot Applicable
A Retrospective Breast Reconstruction Study
United States223 participantsStarted 2019-11-20
Plain-language summary
To collect data on patients who have previously undergone breast reconstruction utilizing SimpliDerm and other HADMs.
Who can participate
SexFEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Female patient who underwent immediate breast reconstruction post-mastectomy; either direct to implant or with a tissue expander followed by exchange for a saline or gel implant.
* HADMs such as: InteguPly, SimpliDerm, AlloDerm, FlexHD, DermACELL, Cortiva, or AlloMax used in the breast reconstruction.
Exclusion Criteria:
* Female patient who underwent cosmetic/aesthetic breast augmentation procedure or revision.
* Female patient who underwent delayed breast reconstruction procedure.
* Female patient who underwent revision of previous breast reconstruction procedure.
What they're measuring
1
Occurrence of Events
Timeframe: From date of surgery through study completion, an average of 9 months