Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2025-12-26 @ 1:16 AM
Study NCT ID:
NCT05484934
Status:
UNKNOWN
Last Update Posted:
2022-10-14
First Post:
2022-07-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Investigate Wound Healing, Aesthetics & Pt Satisfaction Post NAC Reconstruction Using a Decellularized Donor NAC Graft
Sponsor:
BioAesthetics
Organization:
Study Overview
Official Title:
Open Label Case Reports Investigating Wound Healing, Aesthetic Outcomes, and Patient Satisfaction Following Nipple-Areolar Complex (NAC) Reconstruction Using a Decellularized Donor NAC Graft (DCLNAC)
Status:
UNKNOWN
Status Verified Date:
2022-10
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To evaluate the wound healing response following nipple-areolar complex (NAC) reconstruction with a decellularized donor NAC graft (DCLNAC)
Detailed Description:
Primary Objective
• To evaluate the wound healing response following nipple-areolar complex (NAC) reconstruction with a decellularized donor NAC graft (DCLNAC).
Secondary Objectives
* To evaluate nipple dimensions and vascularization up to 12 months following nipple reconstruction using DCLNAC.
* To evaluate patient satisfaction and well-being up to 12 months following nipple reconstruction using DCLNAC.
Exploratory Objectives
* To assess operative time and physician preference for either the DCLNAC or the standard of care (SOC) surgical NAC reconstruction procedures.
* To evaluate nipple sensitivity.
• To evaluate the wound healing response following nipple-areolar complex (NAC) reconstruction with a decellularized donor NAC graft (DCLNAC).
Secondary Objectives
* To evaluate nipple dimensions and vascularization up to 12 months following nipple reconstruction using DCLNAC.
* To evaluate patient satisfaction and well-being up to 12 months following nipple reconstruction using DCLNAC.
Exploratory Objectives
* To assess operative time and physician preference for either the DCLNAC or the standard of care (SOC) surgical NAC reconstruction procedures.
* To evaluate nipple sensitivity.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: