Trials Sponsors Conditions Drugs Pricing

Conditions

Exuding Wounds Ulcer, Leg Wound

Outcome Measures

Primary Outcomes (4)

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 (6)

Number of days between visits
Enrollment to study completion (4 weeks)
Weight of dressing after use using a balance
Enrollment to study completion (4 weeks)
Registration of time for display activation
Enrollment to study completion (4 weeks)
Questionnaire regarding leakage, strike-through, exudate viscosity
Enrollment to study completion (4 weeks)
Questionnaire regarding wound status
Enrollment to study completion (4 weeks)
+1 more secondary outcomes

Study Arms (1)

Participants

Patients with exuding wounds

Device: Moisture sensor wound dressing

Interventions

Moisture sensor wound dressingDevice

Clinical procedure for change of wound dressing

Also known as: DryMax Sensor

Participants

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

Patients from primary health care

You may qualify if:

male or female, ≥18 years

Sponsors & Collaborators

Primary Health Care Center, Department of Health Medicine and Caring Sciences, Linköping University, Linköping, Sweden
Type not reportedcollaborator
Fredrik Iredahl
Otherlead

Study Sites (1)

Primary Health Care Center in Österlötland

Linköping, Sweden

MeSH Terms

Conditions

Leg UlcerWounds and Injuries

Condition Hierarchy (Ancestors)

Skin UlcerSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

Fredrik Iredahl, MD. PhD.
Linkoeping University
PRINCIPAL INVESTIGATOR

Enrollment

4 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: PROSPECTIVE
Sponsor Type: OTHER
Responsible Party: SPONSOR INVESTIGATOR
PI Title: Principal Investigator

Study Record Dates

First Submitted

April 26, 2021

First Posted

May 18, 2021

Study Start

May 21, 2021

Actual (reported)

Study Stopped

Clinical Study of Moisture Sensor Dressing Used for Exuding Wounds

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (4)

Secondary Outcomes (6)

Study Arms (1)

Participants

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (4)

Secondary Outcomes (6)

Study Arms (1)

Participants

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations