Observational Study to Evaluate the Influence of Undercas... | NCT05347927

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

NCT05347927

Sponsor

BSN Medical GmbH

Status

Completed

Last Update Posted

Jan 31, 2025Actual

Enrollment

108Actual

Phase

Not provided

Conditions

Skin Microbiome
Undercast Materials

Interventions

water resistante padding
non water resistante padding

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 30, 2022Actual

Primary Completion Date

Sep 30, 2024Actual

Completion Date

Dec 31, 2024Actual

First Submitted Date

Apr 21, 2022

First Submission Date that Met QC Criteria

Apr 21, 2022

First Posted Date

Apr 27, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 29, 2025

Last Update Posted Date

Jan 31, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

108Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Test group		will receive water resistante padding and a cast	Device: water resistante padding
Control group		will receive traditional non-water resistante padding and cast	Device: non water resistante padding

Interventions

Name	Type	Description	Arm Group Labels	Other Names
water resistante padding	Device	Delta-Dry® Softliner Tensoban® Delta-Dry®	Test group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
products´ influence on skin microbiome during fracture management	Quantity of bacteria in the skin microbiome	3 weeks
products´ influence on skin microbiome during fracture management	Taxonomic composition of skin microbiome	3 weeks
products´ influence on skin microbiome during fracture management	Alpha diversity of skin microbiome	3 weeks
products´ influence on skin microbiome during fracture management	Beta diversity skin microbiome	3 weeks

Secondary Outcomes

Measure	Description	Time Frame
Number of adverse events during study per product		3 weeks
General product performance		3 weeks
Treatment comfort

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Subjects with broken forwarm receiving short arm cast

Sampling Method

Non-Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
Ommelander Ziekenhuis		Groningen	Scheemda	9679 BJ	Netherlands
Wilhelmina Ziekenhuis Assen (Assen, NL)