Breast Reconstruction, Mammoplasty, Scar, Scarring
Conditions
Brief summary
The purpose of this study is to evaluate effectiveness of Granexin® gel in reducing scar formation in surgical incisional wounds.
Detailed description
Participants that meet screening criteria will be eligible for randomization providing all other criteria are met. Participants enrolled will receive study drug for 3 days. The participants will have an additional follow-up period to assess scarring of both Granexin® gel and Vehicle gel incisions through end of study at Month 12.
Interventions
DRUGGranexin® gel 100 μM
Administered during the surgery, 24 hours post-surgery, and 48 hours post-surgery.
DRUGGranexin® gel 200 μM
Administered during the surgery, 24 hours post-surgery, and 48 hours post-surgery.
DRUGVehicle gel
Administered during the surgery, 24 hours post-surgery, and 48 hours post-surgery.
Sponsors
Xequel Bio, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Female subjects aged 18 years and older 2. Female subjects of childbearing potential must have a negative urine or blood pregnancy test at screening and baseline. 3. Female subjects of childbearing potential must agree to use ONE of the following birth control methods throughout the study: * abstinence * condom with spermicide * diaphragm with spermicide * Hormonal contraceptive * intra-uterine device Non-childbearing confirmed by prior documentation of at least one of the following: * postmenopausal * surgically sterilized 4. Subjects undergoing a breast surgery procedure with bilateral anchor incisions 5. Signed informed consent form
Exclusion criteria
1. Subjects with breast implants or history of breast implants 2. Subjects undergoing breast surgery requiring breast implants 3. Subjects requiring nipple grafting using any technique 4. Subjects with a history of infection in the past 6 months in the intended area of incision 5. Subjects with breast tattoos in the intended area of the incision 6. Subjects with known skin sensitivity to Tegaderm™ 7. Subjects with a history of keloids 8. Known conditions of collagen vascular diseases 9. Subjects with clinically significant medical conditions as determined by the Investigator, which would impair wound healing including renal, hepatic, hematologic, neurologic or autoimmune disease. Examples include but are not limited to: 1. Renal insufficiency as an estimated GFR, which is \< 30 mL/min/1.7m2 2. Abnormal blood biochemistry defined as 3 times that of the upper limit of the normal range 3. Hepatic insufficiency defined as total bilirubin \> 2 mg/dL or serum albumin \< 25 g/L 4. Hemoglobin \< 9 g/dL 5. Hematocrit \< 30% 6. Platelet count \< 100,000 μL 10. Any history within the last 5 years or the presence of any active systemic cancer (with the exception of non-melanoma skin cancer) 11. Current treatment with systemic corticosteroids (\>15 mg/day). Washout period is 30 days prior to screening 12. Current treatment with biologic immunosuppressive agents or chemotherapeutic agents. Wash out period for short term immunosuppressive agents is 14 days prior to screening 13. Previous history of radiation therapy to the chest 14. Known inability to complete required study visits during study participation 15. A psychiatric condition (e.g., suicidal ideation), chronic alcohol consumption, or drug abuse problem determined from the subject's medical history, which, in the opinion of the Investigator, may pose a threat to subject compliance 16. Use of any investigational drug or therapy within the 28 days prior to screening 17. History of previous breast surgeries in the area where the incisions are to be made 18. Currently pregnant, pregnant during the 6 months prior to screening, lactating, or breastfeeding 19. Any other factor, which may, in the opinion of the Investigator, compromise participation and follow-up in the study 20. Any areolar abnormalities that are deemed clinically significant by the Investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in scar severity at Month 12 | Month 12 | Assessed using the Patient and Observer Scar Assessment Scale (POSAS). The POSAS has a rage from 6 to 60 with higher scores indicating worse outcomes. One scale will be used for each segment of the scar. The score from each segment will be combined into one score. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in scar severity at Month 6, Month 9 and Month 12 | Month 6, Month 9 and Month 12 | Assessed using the Scar Cosmesis Assessment and Rating (SCAR) Scale. The SCAR scale has a range of 0 (best possible scar) to 15 (worst possible scar). |
| Change in scar severity at Month 9 | Month 9 | Assessed using the Patient and Observer Scar Assessment Scale (POSAS). The POSAS has a range from 6 to 60 with higher scores indicating worse outcomes. One scale will be used for each segment of the scar. The score from each segment will be combined into one score. |
| Proportion of subjects with incision healing complications | Day 1 to Month 12 | Investigator's assessment of incision healing complications |
| Proportion of subjects with incision infection | Day 1 to Month 12 | Investigator's assessment of presence or absence of infection |
Countries
United States
Outcome results
None listed