Clinical trial NCT04936204: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Wounds
Lead sponsor: Fidia Farmaceutici s.p.a.
Sponsor class: INDUSTRY
First posted: 2021-06-23
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A prospective, randomized, controlled, single-blind clinical investigation
Primary purpose: TREATMENT

Brief summary: The clinical investigation plan will include a Screening/Baseline visit (V1) in which patients will be screened on the basis of inclusion/exclusion criteria and clinically evaluated. Screened and eligible patients will be randomly assigned in one of the two groups: Group 1 will receive ConnettivinaBio Plus cream whereas Group 2 will receive ConnettivinaBio cream. Lesions will be cleaned and a photo will be acquired with a digital camera.

In both groups, the schedule treatment will consist of daily medication changes.

Wound Bed Score, clinical signs of localized infection, measurement of the wound area, collection of the swab, according to the Levine's technique, EQ-5D questionnaire to the patient will be assessed on Day 1 (V1, baseline visit), 7 (V2), 14 (V3), 21 (V4) and 28 (V5) post-baseline. Treatments in both groups (ConnettivinaBio Plus or ConnettivinaBio) will be applied for a maximum period of 28 days. The easiness of treatment application will be also recorded at V5.


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.

Primary outcomes:
measure: improving the wounds bed conditions in wounds at high risk of infection, after 14 days of treatment, compared to ConnettivinaBio cream
timeFrame: at day 14
Secondary outcomes:
measure: improving the wound bed condition
timeFrame: At days 7, 21 and 28
measure: improving the wound bed condition
timeFrame: At days 7, 14, 21 and 28
measure: control of bacterial load of wounds
timeFrame: At days 7, 14, 21 and 28
measure: control on signs of wound infection
timeFrame: At days 7, 14, 21 and 28
measure: improving the reepithelization rate
timeFrame: At days 7, 21 and 28
measure: improving patient's quality of life
timeFrame: At days 7, 14, 21 and 28
measure: clinician's global assessment of the lesion
timeFrame: At days 7, 14, 21 and 28
measure: easiness of the treatment application
timeFrame: at day 28
measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
timeFrame: throughout study completion, an average of 1 year
Other outcomes:
Locations:
city: Firenze
country: Italy
facility: Casa di Cura Villa Donatello
Study officials:
References: