Effectiveness and Tolerability of Fitostimoline Plus vs Connettivina Bio Plus in Skin Graft

NCT05447793 | Unknown

• 1 other identifier: 1808
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Partial thickness skin grafts are widely used to cover large losses of substance secondary to trauma, burns, ulcers, neoplasms. The donor site (SD), in principle, heals by spontaneous re-epithelialization from the epithelial residues of the skin appendages. In the post-surgical management of the collection area, in order to optimize treatment, the following are necessary: control of nappy bleeding, management of transudate, avoid superinfection, promote rapid re-epithelialization and pain control. The objective of the research proposed by us wants to compare two methods of dressing of the SD, one of which involves the use of impregnated gauze and cream with Rigenase and poliesanide (Fitostimoline Plus®) while the other the use of impregnated gauze and cream with hyaluronic acid, sodium salt and 1% silver sulfadiazine (Connettivina Bio Plus®) associated with non-adhesive polyurethane foam (i.e. without adhesive edge, i.e. Mepilex). The prospective, multicentre study will be conducted at the UOC of Plastic and Reconstructive Surgery of our AOU directed by Prof F. D'Andrea and the UOC of Plastic and Reconstructive Surgery of ASUGI of Trieste directed by Prof Z. Arnez. To date, there is still no standardized protocol on the wound care of the graft harvesting area. If the literature is evaluated, in fact, large variations in the management of SD are observed with a discrepancy between the practice and the evidence reported in the literature. The purpose of our research is precisely to review the literature on the effectiveness of dressings at the sampling site level in terms of reducing pain and promoting rapid healing.

Conditions

Wounds and Injuries; Skin Graft Scar; Skin Graft Complications

Outcome Measures

Primary Outcomes (1)

• Scarring

  Comparing the two formulations in evaluating the scarring percentage of the lesions

  one month

Study Arms (2)

Fitostimoline Plus

Formulation in gauzes and cream based on a particular Triticum Vulgare Extract (Rigenase®) and polyhexanide, an antiseptic which does not give any bacterial resistance.

Device: Fitostimoline plus; Device: Connettivina bio plus

Connettivina Bio Plus

Formulation in gauzes and cream based on hyaluronic acid and silver sulphadiazine.

Device: Fitostimoline plus; Device: Connettivina bio plus

Interventions

Fitostimoline plus DEVICE

Formulation in gauzes and cream

Connettivina Bio Plus; Fitostimoline Plus

Connettivina bio plus DEVICE

Formulation in gauzes and cream

Connettivina Bio Plus; Fitostimoline Plus

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All pantients aged between 18 and 80 years will be included in the trial if they accept to sign the informed consent.

You may qualify if:

• informed consent Age \> 18 years

You may not qualify if:

• Absence of informed consent Age \< 18 years

Sponsors & Collaborators

• Federico II University: lead

Study Sites (1)

Barbara Maglione

Napoli, Naples, 80123, Italy

RECRUITING

MeSH Terms

Conditions

Wounds and Injuries

Central Study Contacts

barbara NA maglione, MB

CONTACT

3343293357; barbara.maglione@farmadamor.it

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: June 30, 2022
• First Posted: July 7, 2022
• Study Start: January 18, 2021
• Primary Completion: December 18, 2021
• Study Completion: September 18, 2022
• Last Updated: July 7, 2022

Record last verified: 2022-07

Locations

IT (1)