Evaluating ConnettivinaBio Plus Cream for Wound Management

A Prospective, Randomized, Controlled, Single-blind Clinical Investigation to Evaluate the Safety and Performance of ConnettivinaBio Plus Cream Compared to ConnettivinaBio Cream in the Management of Wounds in Patients at High Risk of Infection

This study is testing whether ConnettivinaBio Plus cream works better than regular ConnettivinaBio cream for treating wounds in people who are at high risk of infection.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Fidia Farmaceutici s.p.a. (Industry-sponsored)
• Drugs / interventions: radiation
• Locations: 1 site (Firenze)
• Trial ID: NCT04936204 on ClinicalTrials.gov

What this trial studies

This clinical investigation evaluates the safety and performance of ConnettivinaBio Plus cream compared to ConnettivinaBio cream in managing wounds in patients at high risk of infection. Eligible participants will be randomly assigned to receive one of the two creams, with daily treatment changes over a maximum period of 28 days. The study will assess various clinical outcomes, including wound bed score and signs of localized infection, at multiple follow-up visits. Additionally, patient-reported outcomes will be collected using the EQ-5D questionnaire.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with non-infected wounds at risk of infection.

Not a fit: Patients with infected wounds or those without factors associated with increased risk of infection may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve wound management and reduce infection rates in high-risk patients.

How similar studies have performed: There is limited information on similar studies, making this approach relatively novel.

Eligibility criteria

Inclusion Criteria:

* Signed written informed consent.
* Male or female ≥ 18 years
* Having wounds (both chronic or acute wounds regardless of etiology), with the following characteristics:
* Non infected
* Wound Bed Score ≥4 and \<13
* Wound area ≤ 100 cm2
* Patient having one or more factors associated with increased risk of wound infection (IWII, 2016)
* Patient able to read and understand the language and content of the study material, understand the requirements for follow-up visits, is willing to provide information at the scheduled evaluations and is willing, able and ensuring to comply with the study requirements for the whole study period.

Exclusion Criteria:

* Absence of factors associated with increased risk of wound infection
* Infected wounds - where infection is defined by:

For chronic wounds:

A combination of three or more signs or symptoms of local infection: periwound skin erythema, local heat, persistent pain, oedema of wound.s edge, malodour, pus and heavy exudation (Cutting KF, 1994; Trial C, 2010);

For acute wounds:

Cellulitis or pus or abscess, Delayed healing, erythema, hardening of edge, serous-purulent drainage, malodour

* Non-vital tissue greater than 25% of the total wound area
* Heavily exuding wounds
* Presence of fistula
* History of connective tissue disease, e.g., systemic lupus erythematosus, systemic sclerosis, Sjögren's syndrome or mixed connective tissue disease
* Active malignant disease
* Active sickle cell disease
* radiation therapy
* Known allergy to any of the devices' constituents
* Pregnant and breastfeeding women
* Subjects unable to understand informed consent or having a high probability of non- compliance with the study procedures and or non-completion of the study according to investigator's judgement.

Where this trial is running

Firenze

• Casa di Cura Villa Donatello — Firenze, Italy (Recruiting)

Study contacts

• Study coordinator: Nicola Giordan

Conditions Wounds