Safety and Efficacy of Collagen-Based Biological Dressings in the Management of Chronic Superficial Skin Wounds in Non-Complex Trauma: A Post-Marketing Surveillance Study

Biological dressings such as collagen and hyaluronic acid represent the main advanced tools that plastic surgeons, dermatologists and vulnologists use today to treat chronic wounds or ulcers that do not tend to heal. These types of dressings are important because they create a moist and physiological interface at the wound level, are of natural origin, easy to use, hypo-allergenic, economical and do not create discomfort for the patient during dressing changes. We treated 128 patients (divided into four groups based on type of dressing) with non-complex superficial chronic wounds in comparison with a traditional dressing (fitostimoline gauze or polyurethane foam). We analyzed wound characteristics, healing time, and operator and patient satisfaction. A significantly higher recovery rate was observed in the “Collagen-coated plates” treatment group compared to Standard Treatment. Additionally, a significantly higher probability of recovery was observed compared to the alternative two experimental devices (Collagen-coated plates + HA and Collagen-based spray). However, the main limitation of the randomization of this study is the presence in the “Collagen-based spray” group of localized wounds, mainly in the fingers and hand. No side effects were reported in relation to the procedures or the experimental products. Collagen may be considered as a valuable therapeutic tool in non-complex chronic wounds by virtue of its low immunogenicity, flexibility and applicability in biocompatible scaffolds, and represents driving force toward enhanced wound care.

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A Post-marketing Surveillance Study of Chronic Wounds Treated With a Native Collagen Calcium Alginate Dressing

Wound Management & Prevention ◽

10.25270/owm.2018.4.3843 ◽

2018 ◽

Vol 64 (4) ◽

pp. 38-43 ◽

Cited By ~ 3

Author(s):

Mathhew Sabo ◽

Lam Le ◽

Raphael Yaakov ◽

Marissa Carter ◽

Thomas Serena

Keyword(s):

Calcium Alginate ◽

Chronic Wounds ◽

Surveillance Study ◽

Post Marketing Surveillance ◽

Native Collagen ◽

Post Marketing

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Grapefruit Derived Extracellular Vesicles as a Promising Cell-free Therapeutic Tool for Wound Healing

Food & Function ◽

10.1039/d0fo02953j ◽

2021 ◽

Author(s):

Yağız Savcı ◽

Oğuz Kaan Kaan Kırbaş ◽

Batuhan Turhan Bozkurt ◽

Ezgi Avşar Abdik ◽

Pakize Neslihan Taşlı ◽

...

Keyword(s):

Wound Healing ◽

Extracellular Vesicles ◽

Chronic Wounds ◽

Wound Care ◽

Therapeutic Tool

Due to the prevalence of individuals suffering from chronic wounds, developing safe and effective wound care agents is one of the more prominent fields of research in biology. However, wound...

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Healing venous ulcers with different modalities of leg compression

Phlebologie ◽

10.1055/s-0037-1622150 ◽

2006 ◽

Vol 35 (05) ◽

pp. 349-355 ◽

Cited By ~ 9

Author(s):

E. O. Brizzio ◽

G. Rossi ◽

A. Chirinos ◽

I. Cantero ◽

G. Idiazabal ◽

...

Keyword(s):

Wound Care ◽

Univariate Analysis ◽

Compression Therapy ◽

Healing Time ◽

Clinical Parameters ◽

Compression Stockings ◽

Local Pressure ◽

Ulcer Size ◽

Venous Ulcers ◽

Unexpected Findings

Summary Background: Compression therapy (CT) is the stronghold of treatment of venous leg ulcers. We evaluated 5 modalities of CT in a prospective open pilot study using a unique trial design. Patients and methods: A group of experienced phlebologists assigned 31 consecutive patients with 35 venous ulcers (present for 2 to 24 months with no prior CT) to 5 different modalities of leg compression, 7 ulcers to each group. The challenge was to match the modality of CT with the features of the ulcer in order to achieve as many healings as possible. Wound care used standard techniques and specifically tailored foam pads to increase local pressure. CT modalities were either stockings Sigvaris® 15-20, 20-30, 30-40 mmHg, multi-layer bandages, or CircAid® bandaging. Compression was maintained day and night in all groups and changed at weekly visits. Study endpoints were time to healing and the clinical parameters predicting the outcome. Results: The cumulative healing rates were 71%, 77%, and 83% after 3, 6, and 9 months, respectively. Univariate analysis of variables associated with nonhealing were: previous surgery, presence of insufficient perforating and/or deep veins, older age, recurrence, amount of oedema, time of presence of CVI and the actual ulcer, and ulcer size (p <0.05-<0.001). The initial ulcer size was the best predictor of the healing-time (Pearson r=0.55, p=0.002). The modality of CT played an important role also, as 19 of 21 ulcers (90%) healed with stockings but only 8 of 14 with bandages (57%; p=0.021). Regression analysis allowed to calculate a model to predict the healing time. It compensated for the fact that patients treated with low or moderate compression stockings were at lower risk of non-healing. and revealed that healing with stockings was about twice as rapid as healing with bandages. Conclusion: Three fourths of venous ulcers can be brought to healing within 3 to 6 months. Healing time can be predicted using easy to assess clinical parameters. Irrespective of the initial presentation ulcer healing appeared more rapid with the application of stockings than with bandaging. These unexpected findings contradict current believes and require confirmation in randomised trials.

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EDPS of Clinical Case Record and Scientific Document in the Industry Post-Marketing Surveillance of Drugs

Methods of Information in Medicine ◽

10.1055/s-0038-1635432 ◽

1983 ◽

Vol 22 (03) ◽

pp. 135-148 ◽

Cited By ~ 3

Author(s):

T. Kitaguchi ◽

T. Nojiri ◽

S. Suzuki ◽

T. Fukita ◽

T. Kawana

Keyword(s):

Data Base ◽

Clinical Case ◽

Drug Information ◽

Case Record ◽

Post Marketing Surveillance ◽

Japanese Character ◽

Record Data ◽

Post Marketing ◽

On Line ◽

Line Drug

In order to meet the multifarious needs for drug information and to cope with the post-marketing surveillance of drugs adequately, an on-line drug information network, which is composed of two data bases, clinical case record data base and literature data base, has been developed. Primary considerations in designing these systems were input of clean data, accurate input, insuring that no ADRs are overlooked, accumulation of the latest data, saving manpower required for processing, and processing large quantities of data. This system is also designed to input and to output in Japanese character.

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