A Randomized, Blinded Clinical Evaluation of Efficacy and Safety of Pure Hydration with Zinc vs. Placebo for Scar Reduction in Bilateral Breast Surgery Subjects

Study ID
STU 012012-172

Cancer Related
No

Healthy Volunteers
No

Study Sites

Contact
Jessica Harper
214-645-3967
jessica.harper@utsouthwestern.edu

Principal Investigator
Bardia Amirlak

Summary

This will be a double-blind, randomized clinical trial of the effects of Pure Hydration with Zinc versus placebo on bilateral breast incisions. Fifteen (15) bilateral breast surgery patients will be enrolled into the study. Subjects will have right and left incisional lines randomized to Pure Hydration with Zinc or placebo. Subjects will apply the assigned product to each site three times a day for 12 weeks. They will come into the clinic for follow up visits at 6 and 12 weeks to be evaluated by the investigator. Photos will be taken of the surgical sites at each visit.

if subject consented to participate in the sub-study of biopsy procedure, biopsies of each scar will be taken at the 12 week visit for wound healing and fibrosis analyses by hemotoxylin and eosin (H [and] e) and trichrome stain, respectively. These biopsies are being done as part of the research and will be tested as described. Leftover (de-identified) samples will be kept in the uT Southwestern Department of Plastic Surgery research laboratories and may be used for future testing. Subjects may request not to have samples stored for future testing.

Data will be recorded into the source documents, transcribed onto standardized case report forms, and subsequently entered into a database for tabulation and analysis.


Participant Eligibility

a. Elected to undergo bilateral breast surgery (augmentation or lift);
b.Female subjects age is 21-65 years old on date of signing the Information and Consent Form (ICF);
c.Spanish-speaking subjects will be eligible to participate