To evaluate the wound healing response following nipple-areolar complex (NAC) reconstruction with a decellularized donor NAC graft (DCLNAC)
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
36
Implantation of the Nipple-Areolar Complex (NAC) Reconstruction Using a Decellularized Donor NAC Graft (DCLNAC)
St. Charles Surgical Hospital
New Orleans, Louisiana, United States
RECRUITINGTime to complete healing (graft >99% re-epithelialized)
To evaluate the time to complete healing following NAC reconstruction with DCLNAC.
Time frame: 3 months
Healing of the nipple (VAS=Visual Analog Scale) epithelialization
epithelialization (0-100% VAS)
Time frame: 3 months
Healing of the nipple (VAS=Visual Analog Scale) granulation
granulation (0-100% VAS)
Time frame: 3 months
Healing of the nipple (VAS=Visual Analog Scale) ischemia/necrosis
ischemia/necrosis (0-100% VAS)
Time frame: 3 months
Healing of the nipple (VAS=Visual Analog Scale) dehiscence
dehiscence (0-100% VAS)
Time frame: 3 months
Healing of the nipple (VAS=Visual Analog Scale) overall healing
overall healing (0-100% VAS)
Time frame: 3 months
Healing of the nipple (infection) A. no infection B. hyperemia (no infection) C. cellulitis (superficial infection D. abscess or purulent infection
As above
Time frame: 3 months
Nipple projection
Distance from breast mound to tip in millimeters using depth gauge.
Time frame: 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Vascularization by presence of bleeding
vascularization by presence of bleeding using a lancet device
Time frame: 12 months
Evaluate patient satisfaction and well-being preoperatively and serially
Use of a standardized postoperative survey with a LIKERT (numerical) scale up to 12 months following reconstruction.
Time frame: 12 months