Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2025-12-26 @ 1:49 AM
Study NCT ID:
NCT06992960
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-14
First Post:
2025-05-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Scar Healing Effects of ChitoCare Medical Scar Healing Gel in Women Undergoing Breast Reduction or Mastopexy Surgery (CHITOSCAR)
Sponsor:
Primex ehf
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CHITOSCAR
Brief 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: