The classification of antiseptic products to be administered to wounds  another borderline case between medicinal products and medical devices?

Kramer, A. E. J. L.; Kremer, J.A. Hovinga; Assadian, Ojan; Schneider, I; Dähne, H; Schwemmer, J; Müller, Gerd; Siegmund, Werner; Jäkel, Christian

doi:10.5414/cpp44677

Cited by 10 publications

(6 citation statements)

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“…Because dual labeling is generally not accepted by drug administration agencies, these products are regulated by either the medical device or the drug legislation, but not both. Medicinal products are distinguished from medical devices by their pharmacological, metabolic, and/or immunological effects, while the mode of action of medical devices is predominately based on physical aspects [ 14 ].…”

Section: Regulatory Affairs and Test Standards For Disinfectantsmentioning

confidence: 99%

Chemical disinfection in healthcare settings: critical aspects for the development of global strategies

Exner

Bhattacharya

Gebel

et al. 2020

GMS Hygiene and Infection Control; 15:Doc36

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Section: Regulatory Affairs and Test Standards For Disinfectantsmentioning

confidence: 99%

Chemical disinfection in healthcare settings: critical aspects for the development of global strategies

Exner

Bhattacharya

Gebel

et al. 2020

GMS Hygiene and Infection Control; 15:Doc36

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“…Such a value of the biocompatibility index was demonstrated for OCT (BI = 1.7; 2.1) and PHMB (BI = 1.5; 1.4). However, in clinical conditions, the tolerance of the antiseptic is compared with isotonic Ringer's solution, 0.9% NaCl or a neutral hydrogel [2,6,[45][46][47].…”

Section: Discussionmentioning

confidence: 99%

“…The keyword “antiseptic” entered into the search engine included products which included both pharmacological drugs and medical devices. Following the recommendations of experts [ 2 – 6 , 14 , 44 , 45 ] we tried to distinguish between these two types of products. In some studies, the registration category of the preparation was not given, but only its type, concentration and form of the used antimicrobial substance.…”

Section: Discussionmentioning

confidence: 99%

Antiseptics and antimicrobials for the treatment and management of chronic wounds: a systematic review of clinical trials

Cwajda‐Białasik¹,

Mościcka²,

Szewczyk³

2022

pdia

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Introduction:The development of the field related to the treatment of wounds has resulted in the appearance of new antimicrobial active ingredients. Aim: To analyse, evaluate and systematize the available scientific evidence of the effectiveness and safety of antiseptic preparations intended for the treatment of chronic wounds. Material and methods: We conducted a literature review using the advanced search engine in the PubMed database. We used a combination of two English keywords, i.e.: "antiseptic" and "chronic wound". We have selected only clinical, randomized controlled trials. Results: We obtained a total of 825 items (674 full-text works). We included 29 studies in the review. The most frequently evaluated preparation was octenidine dihydrochloride and povidone iodine (pharmacological drugs). Preparations containing polyhexanide, products based on hypochlorite, reactive oxygen species, 1% acetic acid, and specialized antibacterial dressings were also assessed. The new generation of antimicrobial preparations were highly effective, both in the prevention and treatment of infections, and were well tolerated by the tissues and do not interfere with the healing process. The best tolerated and most effective antiseptic was OCT/PE. For cleaning, we recommend OCT-based irrigation fluids, PHMB, or hypochlorite. The maintenance of the antimicrobial effect during the therapy was ensured by a compatible dressing. Conclusions: An antiseptic alone is not effective enough and the therapeutic effect depends to the greatest extent on properly selected causal therapy, preceded by thorough diagnostics.

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“…Regarding the aftercare for open wound treatment, the diversity continues and literature can be found on wound irrigation with sterile fluids, unsterile fluids [8], and antiseptic fluids [9]; antibiotic therapy [5,6]; and use of different wound dressings such as silver-containing hydrofiber [10], hyaluronate hydrogel [11], and essential oils [12]. These different treatment options are combined in various ways, and so far the results regarding reinfection rates and failure of therapy seem to be comparable.…”

Section: Introductionmentioning

confidence: 99%

Simple Wound Irrigation in the Postoperative Treatment for Surgically Drained Spontaneous Soft Tissue Abscesses: Study Protocol for a Prospective, Single-Blinded, Randomized Controlled Trial

Rühle¹,

Oehme²,

Börnert³

et al. 2017

JMIR Res Protoc

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BackgroundSkin abscesses are a frequent encountered health care problem and lead to a significant source of morbidity. They consequently have an essential impact on the quality of life and work. To date, the type of aftercare for surgically drained abscesses remains under debate. This leads to undesirable practice variations. Many clinical standard protocols include sterile wound dressings twice a day by a home-care service to reduce the chance of a recurrent wound infection. It is unknown, however, whether reinfection rates are comparable to adequate wound irrigation with a nonsterile solution performed by the patient. Our hypothesis is that simple wound irrigation with nonsterile water for postoperative wound care after an abscess is surgically drained is feasible. We assume that in terms of reinfection and reintervention rates unsterile wound irrigation is equal to sterile wound irrigation.ObjectiveThe primary aim of this study is therefore to investigate if there is a need for sterile wound irrigation after surgically drained spontaneous skin abscesses.MethodsIn a prospective, randomized controlled, single-blinded, single-center trial based on a noninferiority design, we will enroll 128 patients randomized to either the control or the intervention group. The control group will be treated according to our current, standard protocol in which all patients receive a sterile wound irrigation performed by a home-care service twice a day. Patients randomized to the intervention group will be treated with a nonsterile wound irrigation (shower) twice a day. All patients will have a routine clinical control visit after 1, 3, 6, and 12 weeks in the outpatient clinic. Primary outcome is the reinfection and reoperation rate due to insufficient wound healing diagnosed either at the outpatient control visit or during general practitioner visits. Secondary outcome measures include a Short Form Health Survey, Visual Analog Scale, Patient and Observer Scar Assessment Scale, Vancouver Scar Scale, and the EurolQol 5-Dimension Questionnaire. Those questionnaires will be completed at the outpatient control visits.ResultsThe trial was started in June 2016 and enrolled 50 patients by article publication. Regarding the adherence to our protocol, we found 10% of loss to follow-up until now. Only 2 patients needed reoperation and only 1 patient needed a change of treatment (antiseptic therapy). Most patients are happy with their randomized treatment but as expected some patients in the sterile group complained about timing problems with their working hours and home-care service appointments. Most patients in the nonsterile group are satisfied being able to take care of their wounds independently although some patients still depend on the home-care service for the wound dressing. We are hoping to have enrolled enough patients by summer 2017. The follow-up will take until autumn 2017, and study results are expected to be published by the end of 2017. This trial is solely supported by the cantonal hospital of Lucerne.ConclusionsNonsterile...

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The classification of antiseptic products to be administered to wounds another borderline case between medicinal products and medical devices?

Cited by 10 publications

References 0 publications

Chemical disinfection in healthcare settings: critical aspects for the development of global strategies

Chemical disinfection in healthcare settings: critical aspects for the development of global strategies

Antiseptics and antimicrobials for the treatment and management of chronic wounds: a systematic review of clinical trials

Simple Wound Irrigation in the Postoperative Treatment for Surgically Drained Spontaneous Soft Tissue Abscesses: Study Protocol for a Prospective, Single-Blinded, Randomized Controlled Trial

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The classification of antiseptic products to be administered to wounds  another borderline case between medicinal products and medical devices?

Cited by 10 publications

References 0 publications

Chemical disinfection in healthcare settings: critical aspects for the development of global strategies

Chemical disinfection in healthcare settings: critical aspects for the development of global strategies

Antiseptics and antimicrobials for the treatment and management of chronic wounds: a systematic review of clinical trials

Simple Wound Irrigation in the Postoperative Treatment for Surgically Drained Spontaneous Soft Tissue Abscesses: Study Protocol for a Prospective, Single-Blinded, Randomized Controlled Trial

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The classification of antiseptic products to be administered to wounds another borderline case between medicinal products and medical devices?