Ignite Creation Date:
2024-05-06 @ 6:02 PM
Last Modification Date:
2024-10-26 @ 2:40 PM
Study NCT ID:
NCT05528328
Status:
RECRUITING
Last Update Posted:
2024-02-13
First Post:
2022-08-29
Brief Title:
Post-surgical Scars After the Use of CACIPLIQ20
Sponsor:
Organ Tissue Regeneration Repair and Replacement
Organization:
Organ Tissue Regeneration Repair and Replacement
Study Overview
Official Title:
Post-surgical Scars After the Use of CACIPLIQ20 A Randomized Double-blind Placebo -Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-02
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:
MATRISCAR
Brief Summary:
Following surgical procedures or injury cutaneous scars can develop due to production of collagen-rich connective tissue These scars may be accompanied by redness itching pain and restricted mobility of the skin Typically after a few weeks the scar matures becoming lighter and narrower although full maturation of a scar may take up to 2 years In some cases however cutaneous scars can be unsightly or can even become hyper- trophic or result in keloids
Preventing pathological scarring is much easier than treating scars later and should be started as early as possible after the injury or surgery
CACIPLIQ20 is a medical device used for the treatment of chronic skin ulcers and contains a molecule belonging to the family of ReGeneraTing Agents RGTA RGTAs are biodegradable polymers that mimic the action of heparan sulfates found in the extracellular matrix of injured tissues RGTA accelerates tissue healing in various animal models by stabilizing and protecting heparin-binding growth factors HBGFs and matrix proteins In addition to its effects on hard-to-heal chronic wounds CACIPLIQ20 was found to improve acute wound healing in pre-clinical models and in several case reports and controlled clinical studies A first open label-controlled study showed that the topical application of RGTA improved skin healing in mammoplasty patients and notably reduced oedema and pain in patients who had undergone centrofacial lift surgery compared to untreated patients Results from this first study were confirmed in a double-blind placebo self-controlled trial conducted in two medical institutions in China involving 71 patients The Chinese study showed that a single application of CACIPLIQ20 significantly improved scar healing quality at 14 days as well as scar symptoms including pain swelling and exudate The aim of the MATRISCAR study is to confirm the previous results in a double-blind placebo-controlled randomized clinical trial
Preventing pathological scarring is much easier than treating scars later and should be started as early as possible after the injury or surgery
CACIPLIQ20 is a medical device used for the treatment of chronic skin ulcers and contains a molecule belonging to the family of ReGeneraTing Agents RGTA RGTAs are biodegradable polymers that mimic the action of heparan sulfates found in the extracellular matrix of injured tissues RGTA accelerates tissue healing in various animal models by stabilizing and protecting heparin-binding growth factors HBGFs and matrix proteins In addition to its effects on hard-to-heal chronic wounds CACIPLIQ20 was found to improve acute wound healing in pre-clinical models and in several case reports and controlled clinical studies A first open label-controlled study showed that the topical application of RGTA improved skin healing in mammoplasty patients and notably reduced oedema and pain in patients who had undergone centrofacial lift surgery compared to untreated patients Results from this first study were confirmed in a double-blind placebo self-controlled trial conducted in two medical institutions in China involving 71 patients The Chinese study showed that a single application of CACIPLIQ20 significantly improved scar healing quality at 14 days as well as scar symptoms including pain swelling and exudate The aim of the MATRISCAR study is to confirm the previous results in a double-blind placebo-controlled randomized clinical trial
Detailed Description:
MATRISCAR is a double-blind placebo-controlled self-controlled randomized clinical trial
The main objective of this pivotal trial is to assess the superiority of a single application of CACIPLIQ20 over placebo on the clinical outcomes of the scars at 24 weeks The primary endpoint will be the overall opinion on the appearance of the scar at 24 weeks using the global scar comparison scale centrally performed by an adjudication committee
It is planned to include 50 female patients undergoing bilateral mammoplasty for breast hypertrophy from 3 centers in France Each subjects participation duration in the study is estimated to be 6 months The enrolment period is estimated to be 8 to 10 months
The targeted mammoplasties consist in the surgical reduction of both breasts volume resulting in almost symmetrical scars Surgical incisions of the bilateral breast reduction will be sutured according to local standard procedures CACIPLIQ20 will be administered topically on the vertical and peri-areolar incisions of one breast for 5 minutes after subcutaneous plans suture and just before final skin suture The placebo will be administered in the same manner on the contralateral breast As a result each patient will receive both CACIPLIQ20 and placebo thus reducing the interpersonal variability with a self-controlled design
Standardized two-dimensional 2D photographs of each scar will be collected at 4 12 and 24 weeks by the investigator as well as other clinical outcomes The scars photographs of each patient at each visit will be placed side by side ie 2 photos per patientvisit for a centralized evaluation by an adjudication committee
The treatment assignment for each breast will be randomized at treatment labelling Treatments active and placebo will be dispensed in identical vials of 5 ml identified by treatment numbers and letters R for the right breast L for the left breast The patient investigator and adjudication committee will be blinded during the whole study until all assessments have been performed The independent monitor will ensure blinding is respected
The main objective of this pivotal trial is to assess the superiority of a single application of CACIPLIQ20 over placebo on the clinical outcomes of the scars at 24 weeks The primary endpoint will be the overall opinion on the appearance of the scar at 24 weeks using the global scar comparison scale centrally performed by an adjudication committee
It is planned to include 50 female patients undergoing bilateral mammoplasty for breast hypertrophy from 3 centers in France Each subjects participation duration in the study is estimated to be 6 months The enrolment period is estimated to be 8 to 10 months
The targeted mammoplasties consist in the surgical reduction of both breasts volume resulting in almost symmetrical scars Surgical incisions of the bilateral breast reduction will be sutured according to local standard procedures CACIPLIQ20 will be administered topically on the vertical and peri-areolar incisions of one breast for 5 minutes after subcutaneous plans suture and just before final skin suture The placebo will be administered in the same manner on the contralateral breast As a result each patient will receive both CACIPLIQ20 and placebo thus reducing the interpersonal variability with a self-controlled design
Standardized two-dimensional 2D photographs of each scar will be collected at 4 12 and 24 weeks by the investigator as well as other clinical outcomes The scars photographs of each patient at each visit will be placed side by side ie 2 photos per patientvisit for a centralized evaluation by an adjudication committee
The treatment assignment for each breast will be randomized at treatment labelling Treatments active and placebo will be dispensed in identical vials of 5 ml identified by treatment numbers and letters R for the right breast L for the left breast The patient investigator and adjudication committee will be blinded during the whole study until all assessments have been performed The independent monitor will ensure blinding is respected
Study Oversight
Has Oversight DMC:
None
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?:
None