Abdominal Scar Improvement in Microsurgical Breast Reconstruction
Cicatrix, Breast Reconstruction
About this trial
This is an interventional prevention trial for Cicatrix
Eligibility Criteria
Inclusion Criteria:
- Female Subjects who have undergone unilateral/bilateral microsurgical breast reconstruction with free abdominal flaps within approximately 1 week (4-8 days) prior to study participation.
- Appearance of subject's incision is aesthetically similar across length of incision
- Age >18
- Subject has the ability to read and comprehend as required by the protocol and the informed consent.
- Subject must be able to provide written informed consent prior to participation in the study.
Exclusion Criteria:
- Subjects with a history of collagen vascular disease, cutis laxica, connective tissue disease, psoriasis, or lupus.
- Subjects diagnosed with scleroderma.
- Subjects with known adverse reactions to steri-strip tapes, medical tapes, or adhesives.
- Subjects with oozing, dehiscence, non-closed/healed incisions at time of first application.
- Subjects with inability to maintain adequate care of incision.
- Subjects with a weight loss of > 100 lbs within 6 months from date of surgery.
- Subjects who currently smoke.
- Subjects taking steroid therapy (systemic or inhaled) within 2 months from date of study enrollment.
- Subject does not qualify for the study in the opinion of the investigators.
Sites / Locations
- Stanford University Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Other
Neodyne Device
Control
After eligible patients have provided informed consent, the side of the abdomen to be treated with the Neodyne Device will be randomly selected by opening a sealed randomization envelope. The selected side will be treated with the Neodyne Device through the full study. The Neodyne Device will be applied to a portion of the abdominal incision by the health care provider at 1 week (4-8 days) after the procedure. The other portion of the abdominal incision (Arm Title: Control) will serve as the control and will be treated per the investigator's standard of care. Subjects will return to the Investigator's office for a total of 8 weeks for application and removal of the Neodyne Dressing.
See above