Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2022 Apr 29;11(9):2518.
doi: 10.3390/jcm11092518.

Clinical Evaluation of the Efficacy and Tolerability of Rigenase® and Polyhexanide (Fitostimoline® Plus) vs. Hyaluronic Acid and Silver Sulfadiazine (Connettivina® Bio Plus) for the Treatment of Acute Skin Wounds: A Randomized Trial

Raffaele Russo  1 , Albino Carrizzo  1   2 , Alfonso Barbato  3 , Barbara Rosa Rasile  1 , Paola Pentangelo  1 , Alessandra Ceccaroni  1 , Caterina Marra  1 , Carmine Alfano  1 , Luigi Losco  1
Affiliations

Clinical Evaluation of the Efficacy and Tolerability of Rigenase® and Polyhexanide (Fitostimoline® Plus) vs. Hyaluronic Acid and Silver Sulfadiazine (Connettivina® Bio Plus) for the Treatment of Acute Skin Wounds: A Randomized Trial

Raffaele Russo et al. J Clin Med. .

Abstract

Objectives: Compare the efficacy and tolerability of Connettivina® Bio Plus (Group A) gauze and cream, and Fitostimoline® Plus (Group B) gauze and cream for the treatment of acute superficial skin lesions.

Design: Single-center, parallel, randomized trial. A block randomization method was used.

Setting: University of Salerno-AOU San Giovanni di Dio e Ruggi d'Aragona.

Participants: Sixty patients were enrolled. All patients fulfilled the study requirements.

Intervention: One application of the study drugs every 24 h, and a six-week observation period.

Main outcome measures: Efficacy and tolerability of the study drugs.

Results: In total, 60 patients (Group A, n = 30; Group B, n = 30) were randomized; mean age was 58.5 ± 15.8 years. All patients were included in the outcome analysis. Total wound healing was achieved in 17 patients undergoing treatment with Connettivina® Bio Plus and 28 patients undergoing treatment with Fitostimoline® Plus. The greater effectiveness of the latter was significant (p = 0.00104). In Group B, a significantly greater degree of effectiveness was observed in reducing the fibrin in the wound bed (p = 0.04746). Complications or unexpected events were not observed.

Conclusions: Both Connettivina® Bio Plus and Fitostimoline® Plus are secure and effective for treating acute superficial skin lesions. Fitostimoline® Plus was more effective than Connettivina® Bio Plus in wound healing of acute superficial skin lesions, especially if fibrin had been observed in the wound bed.

Keywords: Connettivina Bio Plus; Fitostimoline Plus; Rigenase; TVE; acute skin wound; aqueous extract of Triticum vulgare; hyaluronic acid; randomized trial; wound healing.

PubMed Disclaimer

Conflict of interest statement

The authors declare no conflict of interest.

Figures

Figure 1
Figure 1
Schematic flowchart of the study.
Figure 2
Figure 2
Effectiveness of treatment protocols. Conn(v1), wound area in patients treated with Connettivina® Bio Plus in V1; Conn (V6), wound area in patients treated with Connettivina® Bio Plus in V6; Fito(v1), wound area in patients treated with Fitostimoline® Plus in V1; Fito (V6), wound area in patients treated with Fitostimoline® Plus in V6.
Figure 3
Figure 3
A 75-year-old female patient presented with a wound dehiscence localized on the medial aspect of the left leg. The patient was randomly assigned to the group treated with Connettivina® Bio Plus cream and gauze. (A) Patient in V1. Wound bed is partially covered with fibrin, wound borders and perilesional skin are erythematous, and edema is observed. (B) Wound in V3, wound area sensibly reduced, wound bed exudate decreased considerably, although fibrin remained. Perilesional skin and wound borders improved overall. (C) Wound in V5. (D) V6, wound completely healed, and perilesional skin was a physiologic color.
Figure 4
Figure 4
A 69-year-old female patient presented with a first- and second-degree burn lesion localized on the left side of the abdomen. The patient was randomly assigned to the group treated with Fitostimoline® Plus cream and gauze. (A) Patient in V1, wound bed is covered with blisters; wound borders and perilesional skin are erythematous and edematous. (B) Patient in V3, wound area sensibly lessened (first-degree burn lesion); fibrin could be detected on the wound bed. Edema and erythema subsided significantly. (C) Wound in V5. (D) V6, wound healed completely.
See this image and copyright information in PMC

References

    1. Järbrink K., Ni G., Sönnergren H., Schmidtchen A., Pang C., Bajpai R., Car J. Prevalence and incidence of chronic wounds and related complications: A protocol for a systematic review. Syst. Rev. 2016;5:152. doi: 10.1186/s13643-016-0329-y. - DOI - PMC - PubMed
    1. Martin J.M., Zenilman J.M., Lazarus G.S. Molecular microbiology: New dimensions for cutaneous biology and wound healing. J. Investig. Dermatol. 2010;130:38–48. doi: 10.1038/jid.2009.221. - DOI - PubMed
    1. Marcasciano M., Kaciulyte J., Mori F.L.R., Lo Torto F., Barellini L., Loreti A., Fanelli B., De Vita R., Redi U., Marcasciano F., et al. Breast surgeons updating on the thresholds of COVID-19 era: Results of a multicenter collaborative study evaluating the role of online videos and multimedia sources on breast surgeons education and training. Eur. Rev. Med. Pharmacol. Sci. 2020;24:7845–7854. doi: 10.26355/eurrev_202007_22289. - DOI - PubMed
    1. Menichini G., Alfano C., Provenzano E., Marrelli M., Statti G.A., Conforti F. Cachrys pungens Jan inhibits human melanoma cell proliferation through photo-induced cytotoxic activity. Cell Prolif. 2012;45:39–47. doi: 10.1111/j.1365-2184.2011.00791.x. - DOI - PMC - PubMed
    1. Ciacci C., Globularia Alypum L. Modulates Inflammatory Markers in the Human Colon and shows a Potential Antioxidant Role in Myeloid Leukemic Cells. Transl. Med. UniSa. 2022;24:4. doi: 10.37825/2239-9747.1028. - DOI - PMC - PubMed

LinkOut - more resources