Evaluation of the Scar Healing Effects of ChitoCare Medical Scar Healing Gel in Women Undergoing Breast Reduction or Mastopexy Surgery (CHITOSCAR)
NCT ID: NCT06992960
Last Updated: 2025-08-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
39 participants
INTERVENTIONAL
2025-09-30
2026-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Active
ChitoCare® medical Scar Healing Gel (Örsáragel) administered topically twice daily for 6 months post-surgery
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.
Control
Amoena CuraScar Mammilla Circles Silicone Scar Patch and Amoena CuraScar Anchors Silicone Scar Patch worn daily (continuous use, minimum 12 hrs per day as per the IFU) for 6 months post-surgery
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* Female ≥ 18 years old
* Having planned or very recently (within 21 days) undergone breast reduction or mastopexy surgery on both breasts
* Not yet begun any treatment aimed at reducing scarring
* Wound is not infected at the time of enrolment
* Able to understand and comply with the requirements of the study
Exclusion Criteria
* Any significant condition that may preclude the participant from the study (e.g. severe depression or psychiatric illness)
* Patients who will require additional surgical procedures during the study
* Patients diagnosed with autoimmune connective tissue diseases
* Previous treatment under this clinical protocol
* Participation in another clinical trial
* Receiving or scheduled to receive a medication or treatment which, in the opinion of the investigator, is known to interfere with, or affect the rate and quality of wound healing
* Allergy to shellfish\* (if unknown, the patient may try a small sample of the IP on their intact skin to assess for any potential allergic reaction.)
* Medical condition likely to require systemic corticosteroids during the study period
* Pregnant or lactating women
* Smoker
18 Years
FEMALE
Yes
Sponsors
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Primex ehf
INDUSTRY
Responsible Party
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Locations
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Klíníkin Ármúla
Reykjavik, Capital Region, Iceland
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CHITOSCAR-25-01
Identifier Type: -
Identifier Source: org_study_id
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