Evaluation of Adhesion Properties in Wound Care Devices | NCT06392165

Studies
Evaluation of Adhesion Properties in Wound Care Devices

NCT06392165

Sponsor

Molnlycke Health Care AB

Status

Unknown status

Last Update Posted

Apr 30, 2024Actual

Enrollment

20Estimated

Phase

Not Applicable

Conditions

Adhesion Properties of Wound Care Devices

Interventions

self-adhesive device

Countries

Sweden

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

Apr 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 24, 2024Estimated

Primary Completion Date

Jun 2025Estimated

Completion Date

Jun 2025Estimated

First Submitted Date

Apr 23, 2024

First Submission Date that Met QC Criteria

Apr 26, 2024

First Posted Date

Apr 30, 2024Actual

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

Apr 26, 2024

Last Update Posted Date

Apr 30, 2024Actual

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

Molnlycke manufactures and markets self-adhesive wound care devices intended to protect various types of wounds during treatment. This study aims to measure and evaluate the adhesion properties of self-adhesive wound care devices. To measure the adhesion properties test strips will be applied to the participant's skin for a predetermined time and will be removed while measuring the adhesion properties afterwards. This method has been chosen since there is no in vitro method available that can simulate adhesion to human skin

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Self-adhesive wound care devices	Other	test devices with adhesive material to be attached to skin	Other: self-adhesive device

Interventions

Name	Type	Description	Arm Group Labels	Other Names
self-adhesive device	Other	Test device which is self-adhesive	Self-adhesive wound care devices

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Peel Off Force	Internal machine shall measure the peel force expressed in Newton.	up to 48 hours

Secondary Outcomes

Measure	Description	Time Frame
Humidity	Humidity shall be evaluated using tactile and visual assessment	up to 48 hours
Redness	Visual assessment of redness of the skin

Other Outcomes

Measure	Description	Time Frame
Adhesive residuals	Adhesive residuals on the skin	up to 48 hours
Loosening	Assessment if the device is still in place or has been fallen of.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Confirmed eligibility and signed consent form.

Exclusion Criteria:

Known plaster allergy or other known contact hypersensitivity
Pregnant or breastfeeding individual.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

67 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Matthew Malone, PhD	Contact	+44 7977815953		matthew.malone@molnlycke.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mölnlycke Health Care AB		Gothenburg		415 02	Sweden

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Masking Info

Masking

None (Open Label)

Masking Description

all participants will receive the same up to 12 test samples, which are randomized intra-individual.

Who Masked

Not provided