Effectiveness and Tolerability of Fitostimoline Plus Cream and Gauze vs Connettivina Bio Plus Cream and Gauze

NCT04596124 | Unknown

• 1 other identifier: Fitostimoline plus
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to compare the efficacy and clinical tolerability of two medical devices in gauze and cream containing the aqueous extract of triticum vulgare and polyhexanide in comparison with two medical devices containing hyaluronic acid and silver sulfadiazine in the treatment of acute skin lesions . The reason why the two types of devices are compared is because hyaluronic acid and silver sulfadiazine represent the gold standard for the treatment of acute skin lesions. Therefore, making a comparison between the activity of the aqueous extract of triticum vulgare and polyhexanide and this gold standard of control in the treatment of acute skin lesions, is useful to better define the efficacy and tolerability of both medical devices in order to eventually expand the therapeutic armamentarium available for the treatment of acute skin lesions

Conditions

Wound Heal; Wound Infection; Wounds and Injuries

Outcome Measures

Primary Outcomes (1)

• Total symptom score

  Total symptom score will be measured by a scale from 0 (absence of symptoms) to 4 (maximum intensity of symptoms).

  46 days

Secondary Outcomes (1)

• Visual Analog Scale

  46 days

Study Arms (4)

fitostimoline plus cream

EXPERIMENTAL

Device: fitostimoline plus

fitostimoline plus gauze

EXPERIMENTAL

Device: fitostimoline plus

connettivina bio plus cream

ACTIVE COMPARATOR

Device: fitostimoline plus

connettivina bio plus gauze

ACTIVE COMPARATOR

Device: fitostimoline plus

Interventions

fitostimoline plus DEVICE

randomized controlled multicentric study

Also known as: connettivina bio plus

connettivina bio plus cream; connettivina bio plus gauze; fitostimoline plus cream; fitostimoline plus gauze

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Outpatient patients (regardless of sex) aged 18 and over;
• Presence of acute injury
• Willingness to cooperate and ability to understand the procedures and purposes of the study;
• Willingness to take part in the study and to adhere to the experimental procedures certified by signing the written informed consent

You may not qualify if:

• Pregnancy or breastfeeding;
• Inadequate contraceptive procedures in fertile women;
• Anamnestic data of any local and / or systemic pathology potentially able to interfere with the study parameters;
• Chronic concomitant treatment with local antiseptics, anti-inflammatory drugs (steroid and non-steroidal), analgesic, antineoplastic, immunosuppressive drugs;
• Immunodeficiency states (eg HIV infection); neoplastic diseases in progress;
• Non-therapeutic use of psychoactive substances;
• Abuse of drugs and / or alcohol;
• Neurological disorders or psychiatric conditions that may affect the validity of the consent and / or compromise the patient's adherence to the study procedures;
• Allergy, hypersensitivity or intolerance known to the constituents of the preparations under study;
• Any condition, medical or otherwise, that could significantly reduce the possibility of obtaining reliable data, achieve the objectives of the study, refine the completion of this;
• Presumption of poor reliability or collaboration;
• Treatment with any investigational drug in the last 30 days prior to the start of the study;
• Patients already enrolled in this study;
• Center staff directly involved in the management of the study and close relatives of that.

Sponsors & Collaborators

• Farmaceutici Damor Spa: lead

Study Sites (1)

Barbara Maglione

Monza, MB, 20900, Italy

RECRUITING

MeSH Terms

Conditions

Wound Infection; Wounds and Injuries

Condition Hierarchy (Ancestors)

Infections

Study Officials

• carmine alfano

  università di salerno

  PRINCIPAL INVESTIGATOR

Central Study Contacts

barbara maglione

CONTACT

+393343293357; barbara.maglione@farmadamor.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PROFESSOR

Model Details: randomized, controlled, multicentric study

Study Record Dates

• First Submitted: October 1, 2020
• First Posted: October 22, 2020
• Study Start: September 18, 2020
• Primary Completion: August 18, 2022
• Study Completion: September 18, 2022
• Last Updated: July 27, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)