Wounds and InjuriesFPNCT05447793
Effectiveness and Tolerability of Fitostimoline Plus vs Connettivina Bio Plus in Skin Graft
An observational study of Wounds and Injuries and Skin Graft Scar, run by Federico II University at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Wounds and Injuries, Skin Graft Scar, Skin Graft Complications
- What is being tested?
- Fitostimoline plus and Connettivina bio plus
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 18 Jan 2021to 18 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All pantients aged between 18 and 80 years will be included in the trial if they accept to sign the informed consent.
Who may be able to join
- informed consent Age > 18 years
Who cannot join
- Absence of informed consent Age < 18 years
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Barbara Maglione
Naples, Naples, 80123
barbara maglione, 3343293357
About this study
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
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.
Read more
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.
Read the detailed 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.
- Being tested
- Fitostimoline plus, Connettivina bio plus
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fitostimoline plusDevice
Formulation in gauzes and cream
Connettivina bio plusDevice
Formulation in gauzes and cream
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Fitostimoline plus; Device: Connettivina bio plus | |
| Connettivina Bio Plus | Formulation in gauzes and cream based on hyaluronic acid and silver sulphadiazine. Receives: Device: Fitostimoline plus; Device: Connettivina bio plus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scarring
Comparing the two formulations in evaluating the scarring percentage of the lesions
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2022
- Study start18 Jan 2021
- Primary completion18 Dec 2021
- Study completion18 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wounds and InjuriesStudies of the same condition, open and under way.
- More trials run by Federico II UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Barbara Maglione, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05447793
- Sponsor's protocol ID
- 1808
- Acronym
- FP
- Status last verified
- Jul 2022
- First submitted
- 30 Jun 2022
- Last updated
- 7 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05447793
- Acronym / sponsor ID
- FP / 1808
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- 18 Jan 2021 (actual)
- Primary completion
- 18 Dec 2021 (actual)
- Study completion
- 18 Sep 2022 (estimated)
- First posted
- 7 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fitostimoline Plus | – | Device: Fitostimoline plus, Device: Connettivina bio plusFormulation in gauzes and cream based on a particular Triticum Vulgare Extract (Rigenase®) and polyhexanide, an antiseptic which does not give any bacterial resistance. |
| Connettivina Bio Plus | – | Device: Fitostimoline plus, Device: Connettivina bio plusFormulation in gauzes and cream based on hyaluronic acid and silver sulphadiazine. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All pantients aged between 18 and 80 years will be included in the trial if they accept to sign the informed consent.
Key inclusion criteria (1 listed)
- informed consent Age > 18 years
Key exclusion criteria (1 listed)
- Absence of informed consent Age < 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fitostimoline plusFormulation in gauzes and cream | Device | Connettivina Bio Plus, Fitostimoline Plus |
| Connettivina bio plusFormulation in gauzes and cream | Device | Connettivina Bio Plus, Fitostimoline Plus |
Primary outcome
Scarring
Time frame: one month
Comparing the two formulations in evaluating the scarring percentage of the lesions
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Wounds and Injuries and Skin Graft Scar, run by Federico II University at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact barbara NA maglione, MB (3343293357, barbara.maglione@farmadamor.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Scarring (time frame: one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2022.