Hypertrophic scar Keloid Postoperative scar Breast augmentation scar Hypertrophic Scar Keloid Cicatrix Breast Implants Mammoplasty Silicones Topical Administration Randomized Controlled Trial
Conditions
Interventions
Topical silicone gel applied to one inframammary incision following bilateral breast augmentation. Applied twice daily for 6 months.,Placebo gel with identical appearance and packaging applied to the
Active Comparator Drug,Placebo Comparator Drug
Dermatix Ultra topical silicone gel,Placebo gel
Sponsors
A.MENARINI (THAILAND)
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Patients undergoing bilateral breast augmentation with inframammary incision. 2.Age 18 years or older. 3.Able to read speak and understand Thai. 4.Willing and able to comply with study procedures. 5.Provide written informed consent.
Exclusion criteria
Exclusion criteria: 1.Active wound infection at surgical site. 2.Comorbidities affecting wound healing such as diabetes mellitus hematologic disorders or dermatologic diseases. 3.History of allergy to silicone gel or silicone based products. 4.Prior chest wall radiotherapy. 5.History of severe keloid formation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Scar severity Baseline, 1 week, 1 month, 3 months, 6 months Vancouver Scar Scale (VSS) score | — |
Secondary
| Measure | Time frame |
|---|---|
| Skin elasticity Baseline, 1 month, 3 months, 6 months Cutometer reading,Skin pigmentation Baseline, 1 month, 3 months, 6 months Mexameter reading,Scar thickness Baseline, 1 month, 3 months, 6 months Ultrasonography | — |
Countries
Thailand
Contacts
Public ContactKongsawate Khaogate
Division of Plastic Surgery, Department of Surgery, Faculty of Medicine Siriraj Hospital, Mahidol University
Outcome results
None listed