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

Launched by FIDIA FARMACEUTICI S.P.A. · Jun 17, 2021

Keywords

ClinConnect Summary

This clinical trial is looking to compare two types of creams, ConnettivinaBio Plus and ConnettivinaBio, to see which one is safer and more effective for treating wounds in patients who are at a higher risk of infection. If you are at least 18 years old and have a non-infected wound that meets certain size and condition criteria, you might be eligible to participate. The study aims to help improve wound care for those who may have difficulty healing due to various health factors.

Participants in the trial will be randomly assigned to receive either of the two creams, and they will have their wounds checked regularly over a 28-day period. This includes daily treatment changes and assessments of the wound's condition, such as size and signs of infection. Throughout the study, participants will also be asked about how easy it is to apply the treatment. If you or a loved one is interested in a study focused on improving wound management, this trial could be a valuable opportunity to contribute to important medical research.

Gender

ALL

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.