Clinical Study of Moisture Sensor Dressing Used for Exudi... | NCT04890769

Studies
Clinical Study of Moisture Sensor Dressing Used for Exuding Wounds

NCT04890769

Sponsor

Fredrik Iredahl

Status

Terminated

Last Update Posted

Mar 18, 2022Actual

Enrollment

4Actual

Phase

Not provided

Conditions

Exuding Wounds
Ulcer, Leg
Wound

Interventions

Moisture sensor wound dressing

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

Mar 2022

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

The study is terminated by the sponsor due to poor participant recruitment and due to limited opportunity to achieve commercial gain.

Expanded Access Info

Start Date

May 21, 2021Actual

Primary Completion Date

Feb 22, 2022Actual

Completion Date

Feb 22, 2022Actual

First Submitted Date

Apr 26, 2021

First Submission Date that Met QC Criteria

May 17, 2021

First Posted Date

May 18, 2021Actual

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

Mar 3, 2022

Last Update Posted Date

Mar 18, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Fredrik Iredahl, Principal Investigator, Vårdcentralen ÅbySponsor-Investigator

Lead Sponsor

Fredrik IredahlOTHER

Collaborators

Name	Class
Primary Health Care Center, Department of Health Medicine and Caring Sciences, Linköping University, Linköping, Sweden	UNKNOWN

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

Observational prospective study of the clinical use of a wound dressing with a moisture sensor for use on exuding wounds.

Detailed Description

The PMCF study will be performed as a prospective and open study of a wound dressing with a moisture sensor on exuding wounds.

Using DryMax Sensor and the display indication - advisory only - might influence the clinician's workflow and the patient's engagement in their care. The PMCF study aims to study the use of the sensor in the clinical procedure of dressing changes in one or more healthcare settings. To study how the new product is received, and how it is used in the workflow, related to its clinical performance.

Furthermore, the aim is to gather safety-related clinical data for common harms within exudate management.

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

No data available

No data is available for this block.

Enrollment

4Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Participants		Patients with exuding wounds	Device: Moisture sensor wound dressing

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Moisture sensor wound dressing	Device	Clinical procedure for change of wound dressing	Participants

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Questionnaire regarding workflow of the clinical procedure for dressing change	Yes/no questions and questions with multiple choices	Enrollment to study completion (4 weeks)
Questionnaire regarding the satisfaction using the device	Scale 1-5 where 1= low, 5 = good	Through study completion, up to 4 weeks
Registration of device deficiencies	Type of device deficiency	Enrollment to study completion (4 weeks)
Registration of device deficiencies	Severity scale 1-3, 1=low, 3=high	Enrollment to study completion (4 weeks)

Secondary Outcomes

Measure	Description	Time Frame
Number of days between visits	Dressing change frequency	Enrollment to study completion (4 weeks)
Weight of dressing after use using a balance	Utilisation of dressings capacity

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

male or female, ≥18 years
presence of an exuding wound, according to the clinician's assessment
the wound is deemed suitable for treatment with DryMax Sensor
an appropriate dressing size is available to be used according to the size of the wound
the participant has given a written informed consent to participate in the study.

Exclusion Criteria:

known pregnancy at the inclusion visit
known or suspected hypersensitivity to the DryMax Sensor or its components
mental inability, reluctance or language difficulties that cause difficulties in understanding the meaning of participating in the study
ongoing treatment with systemic antibiotics
illness or treatment of an indication other than the wound and which, according to the study personnel, can affect the wound treatment, the study, and/or the dressing.

Accepts Healthy Volunteers

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

Patients from primary health care

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Fredrik Iredahl, MD. PhD.	Linkoeping University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Primary Health Care Center in Österlötland		Linköping			Sweden

IPD Sharing Statement Module

Plan to Share IPD

Description

Data will be analyzed and published on a group level.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D007871	Leg Ulcer
D014947	Wounds and Injuries

Ancestor Terms

ID	Term
D012883	Skin Ulcer
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

Browse Leaves

Not provided

Browse Branches

Not provided