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Completed

NCT Number: NCT05347927

Observational Study to Evaluate the Influence of Undercast Material Types on Skin Microbiome

This clinical study will evaluate the clinical performance and the safety of the CE-marked casting and padding materials when used in routine fracture care without any additional invasive methods and within the intended use. As primary objective the cast therapy´s influence on skin microbiome during fracture management will be investigated. Further, the influence of the padding material on the skin microbiome, device comfort, skin conditions, and impact on daily life activities as well as HCP´s and patient´s satisfaction and general product safety and performance are considered as secondary outcomes.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ommelander Ziekenhuis, Groningen, Scheemda, Netherlands

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Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subject ≥ 18 years of age
  • Patient is physically and mentally able to participate in this study
  • Proper understanding of the Dutch language
  • Signed informed consent
  • Fractures to be treated with a short-arm cast without thumb inclusion for the period of 3 weeks (e.g. 2R3A1 = radial styloid avulsion, 2R3A2 = Simple radial fracture, 2U3A1 = Ulnar fracture of the base of the styloid process, 2U3A2= Simple distal ulna fracture, 2R3B1 = Intraarticular fracture of the styloid process of the radius (not displaced) or Triquetrum fracture (non AO classified))

Exclusion criteria

  • Subject <18 years of age
  • Pregnancy, breast feeding
  • Participation in other clinical trials
  • Patient is neither physically nor mentally able to participate in this study
  • Non-intact skin in treatment area (including dermatological issues)
  • Patients with impaired (e.g. Cortisone skin, extremely dry skin, parchment skin) or damaged skin with either a surgical wound or a traumatic wound
  • Medical treatment prior casting which could influence the microbiome
  • Known Blood Circulatory Diseases
  • Known Lymphedema or any general disorder of the lymphatic system
  • Known Osteoporosis
  • Known Diabetes
  • Knowing of one of the following illnesses that might require regular systemic medication: cancer, rheumatic disease
  • Intolerability or documented allergies against cast materials
  • Subjects with not "normal" (unusual) hygienic behavior
  • Suspected drug addiction or alcohol abuse
  • Patients diagnosed HIV-positive or with infectious hepatitis based on self-declaration by subjects

Treatment and study plan

water resistante padding

Device
  • Delta-Dry® Softliner
  • Tensoban®
  • Delta-Dry®

non water resistante padding

Device
  • Delta-Net® Stockinette
  • Delta-Rol®

Primary outcomes

  1. products´ influence on skin microbiome during fracture management

    Time frame: 3 weeks

    Quantity of bacteria in the skin microbiome

  2. products´ influence on skin microbiome during fracture management

    Time frame: 3 weeks

    Taxonomic composition of skin microbiome

  3. products´ influence on skin microbiome during fracture management

    Time frame: 3 weeks

    Alpha diversity of skin microbiome

  4. products´ influence on skin microbiome during fracture management

    Time frame: 3 weeks

    Beta diversity skin microbiome

Secondary outcomes

  1. Number of adverse events during study per product

    Time frame: 3 weeks

  2. General product performance

    Time frame: 3 weeks

  3. Treatment comfort

    Time frame: 3 weeks

  4. Impact on daily life activities

    Time frame: 3 weeks

Sponsors and collaborators

Lead sponsor

BSN Medical GmbH

Industry

Registry information

Official study title

Exploratory, Prospective, Multicenter, Observational Study to Evaluate the Influence of Undercast Material Types on Skin Microbiome

Acronym: Microbiome II

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Apr 27, 2022
Registry last updated
Jan 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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