NCT06992960

Evaluation of the Scar Healing Effects of ChitoCare Medical Scar Healing Gel in Women Undergoing Breast Reduction or Mastopexy Surgery (CHITOSCAR)

A Prospective, Randomised, Split-Body, Controlled, Non-Inferiority Clinical Study on the Scar Healing Effects of ChitoCare Medical Scar Healing Gel in Women Undergoing Breast Reduction or Mastopexy Surgery (CHITOSCAR)

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 39 (estimated)
• Sponsor: Primex ehf · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Patients undergoing breast reduction or mastopexy surgery will be screened and recruited for participation in the study. Eligible patients will act as their own control with one breast receiving the active intervention (ChitoCare® medical Scar Healing Gel) and the other receiving standard of care (Amoena CuraScar Mammilla Circles Silicone Scar Patch and Amoena CuraScar Anchors Silicone Scar Patch). The active and control interventions will be applied for six months, and participants will be followed for up to 12 months. The scar properties of each breast will be assessed at study initiation (Day 0) and at study visits at 3, 6, 9, and 12 months using the Patient and Observer Scar Assessment Scale (POSAS) and via blinded assessment of photographs. Other subjective parameters such as pain, itching, and overall perception of the healed wound will be collected at each study visit via the POSAS, and patients' opinion, preferences, and compliance regarding the treatments will be collected via a basic questionnaire.

Conditions

• Surgical Scars

Interventions

Type	Name	Description
DEVICE	ChitoCare® medical Scar Healing Gel (Örsáragel)	ChitoCare® medical Scar Healing Gel is a topical gel indicated for the treatment of new and old scars. The Scar Healing Gel provides a soothing effect and support to the scar tissue to heal in an orderly manner. It protects against infections, stimulates cell proliferation in old and new scars, as well as correct tissue organization with proper collagen alignment for a better aesthetic appearance and skin flexibility. Ideal for treating scars after accidents, surgery, C-section and cosmetic surgery. For smoother and less visible scars. May be used by the whole population, also elderly and children.
DEVICE	Amoena CuraScar Mammilla Circles Silicone Scar Patch and Amoena CuraScar Anchors Silicone Scar Patch	Amoena CuraScar Mammilla Circles Silicone Scar Patch and Amoena CuraScar Anchors Silicone Scar Patch are silicon-based, single-patient, multi-use scar patches intended for use as scar reduction therapy in surgical breast scars. The silicone creates a moist environment on the scar, which prevents the scar from drying out. It keeps the scar soft and has a positive effect on scar tissue. The devices are specifically designed for breast scarring and are shaped to fit the normal surgical scars experienced after breast surgery.

Timeline

• Start date: 2025-09-01
• Primary completion: 2026-10-01
• Completion: 2026-10-01
• First posted: 2025-05-28
• Last updated: 2025-08-14

Locations

1 site across 1 country: Iceland