Post-surgical Scars After the Use of CACIPLIQ20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-21

Study Completion Date

2024-10-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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®). RGTA®s 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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Aesthetic Outcome of Layered Closure vs. Layered Closure Followed by 2-Octyl Cyanoacrylate

NCT05449457

Scarring

COMPLETED NA

Influence of Sun Protection and Linear Repair of Cutaneous Surgical Defects

NCT05074238

Surgical Wound Wound Heal Wound of Skin +1 more

ACTIVE_NOT_RECRUITING NA

Silicone Gel Versus Onion Extract Gel as Prevention for Postsurgical Scars

NCT01861119

Hypertrophic or Keloid Scars

COMPLETED PHASE3

The Effects of Topical Calcium Glycerophosphate on Surgical Wound Healing and Residual Scarring

NCT01264588

Wound Healing Scarring

COMPLETED NA

Efficacy and Safety of a Nanofat-seeded Biological Scaffold in Healing Lower Limb Surgical Defects

NCT03548610

Wound of Skin Non-melanoma Skin Cancer Skin Graft Complications +2 more

WITHDRAWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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 subject's 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 (i.e. 2 photos per patient/visit), 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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Scars

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is a prospective double-blinded placebo self-controlled trial. 50 female patients undergoing bilateral mammoplasty for breast hypertrophy will be included.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.The treatment assignment for each breast will be randomized.The patient, investigator and adjudication committee will be blinded during the whole study, until all assessments have been performed.

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

This study is a double-blind study. Each product, CACIPLIQ20® or placebo, will be supplied in vials having the same appearance.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

CACIPLIQ20®

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®). 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.

Group Type ACTIVE_COMPARATOR

CACIPLIQ20®

Intervention Type DEVICE

CACIPLIQ20®

placebo

The placebo solution (saline solution) will be administered on the contralateral side.

Group Type PLACEBO_COMPARATOR

Placebo (saline solution)

Intervention Type DRUG

Placebo (saline solution) administered in identic al vials

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

CACIPLIQ20®

Intervention Type DEVICE

Placebo (saline solution)

Placebo (saline solution) administered in identic al vials

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Patients scheduled for bilateral breast reduction (\>300 g by breast) using the conventional superior pedicle technique with inverted-T scars
2. Age between 18 and 85 years
3. Patients having received a full written and oral information about study conduct and objectives
4. Patients who can and are willing to be followed by the study investigator for the duration of the study
5. Patients benefiting from a valid health insurance or social security coverage

Exclusion Criteria

1. Female patients who are pregnant, or lactating
2. Patients with, according to investigator's opinion, a very poor life expectancy
3. Patients intolerant to one of the study device components or to heparinoids
4. Any scar treatment other than the standard of care
5. Previous breast surgery
6. Current malignancy

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No