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

Wounds and Injuries Clinical Trial

— FP  

Official title:

Clinical Evalutation of the Effectiveness and Tolerability of Fitostimoline Plus Cream and Gauze vs Connettivina Bio Plus Cream and Gauze in the Treatment of Skin Graft Controlled Randomized Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05447793
• Other study ID #: 1808
• Status: Recruiting
• Start date: January 18, 2021
• Est. completion date: September 18, 2022

Study information

• Verified date: July 2022
• Source: Federico II University
• Contact: barbara NA maglione, MB
• Phone: 3343293357
• Email: barbara.maglione[@]farmadamor.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

The management of the removal site of a partial thickness graft is still a subject of heated debate where, despite the published works, it is still often treated with empirical methods, sometimes which also differ within the same working group. The treatment of AD usually, despite what has been exposed in numerous scientific papers, only involves the use of greasy gauze impregnated with substances that promote re-epithelialization or simple paraffin gauze.

The aim of our research is to compare the effectiveness of bioactive dressings containing Rigenase in association with polyhexanide (PHMB) - Fitostimoline Plus®- with bioactive dressings with hyaluronic acid and Silver sulfadiazine - Connettivina Bio Plus®- in improving the outcome of patients, evaluating:

• cure rate

• the healing times

• the AD infection rate

• pain control / discomfort

• assessment of the scar

RESEARCH OBJECTIVES AND HYPOTHESIS The objective of the study proposed by us is to compare two methods of treating DS; the first involves the use of impregnated gauze and cream containing Rigenase® + polyhexanide; the second is the use of impregnated gauze and sodium salt hyaluronic acid cream. The secondary dressing is a non-adhesive polyurethane foam in both groups.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: September 18, 2022
• Est. primary completion date: December 18, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• informed consent Age > 18 years

Exclusion Criteria:

• Absence of informed consent Age < 18 years

Related Conditions & MeSH terms

• Skin Graft Complications
• Skin Graft Scar
• Wounds and Injuries

Intervention

Device:
• Fitostimoline plus
Formulation in gauzes and cream
• Connettivina bio plus
Formulation in gauzes and cream

Locations

Country	Name	City	State
Italy	Barbara Maglione	Napoli	Naples

Sponsors (1)

Lead Sponsor	Collaborator
Federico II University

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Scarring	Comparing the two formulations in evaluating the scarring percentage of the lesions	one month