Trials Sponsors Conditions Drugs Pricing

Conditions

Heal Wound Ulcer, Leg

Outcome Measures

Primary Outcomes (2)

Number of Dressing Changes With Sensor Activation at Correct Timing
Sensor activation - measured as indication on the sensor display; indication at correct time, indication but not att correct time, no indication.
Inclusion visit to study completed after 3 dressing changes, 1-2 weeks
Timing of Dressing Change Related to Dressing Size and Weight After Use
Dressing weight after use were measured on a scale and recorded. The weight were compared to a predefined table. Dressing size 10x10 cm: Changed too early \<11 g Correct change 11-26 g Changed too late \>26 g Dressing size 10x20 cm: Changed too early \<17 g Correct change 17-62 g Changed too late \>62 g Dressing size 20x20 cm: Changed too early \<26 g Correct change 26-109 g Changed too late \>109 g
Inclusion visit to study completed after 3 dressing changes, 1-2 weeks

Secondary Outcomes (3)

Complications if the Dressing Was Switched Too Late.
Inclusion visit to study completed after 3 dressing changes, 1-2 weeks
Level of Usability
Inclusion visit to study completed after 3 dressing changes, 1-2 weeks
Wound Size After Three Dressing Changes
At final dressing change no.3 (after 1-2 weeks)

Study Arms (2)

A-B-A

EXPERIMENTAL

Investigational device is Absorbest moisture sensor in variant A and variant B, placed on the backside of the wound dressing DryMax Extra Soft. Participants performed three dressing changes. They first received variant A, at next dressing change they received variant B, and on the third dressing change they received variant A again. No washout periods.

Device: Sensor activation (on DryMax Extra Soft)

B-A-B

EXPERIMENTAL

Investigational device is Absorbest moisture sensor in variant A and variant B, placed on the backside of the wound dressing DryMax Extra Soft. Participants performed three dressing changes. They first received variant B, at next dressing change they received variant A, and on the third dressing change they received variant B again. No washout periods.

Device: Sensor activation (on DryMax Extra Soft)

Interventions

Sensor activation (on DryMax Extra Soft)Device

Study profile of sensor activation

A-B-AB-A-B

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+)

You may qualify if:

Presence of moderate to highly exuding leg ulcer by clinician assessment
Wound deemed suitable for treatment with study product

Sponsors & Collaborators

S2Clinic
Othercollaborator
Absorbest AB
Othercollaborator
Swedish Energy Agency

Study Sites (2)

Hudkliniken, University hospital

Linköping, Region Östergötland, Sweden

S2Clinic

Linköping, Sweden

MeSH Terms

Conditions

Leg Ulcer

Condition Hierarchy (Ancestors)

Skin UlcerSkin DiseasesSkin and Connective Tissue Diseases

Limitations and Caveats

Small trial, a first test of concept using a moisture sensor on top of a wound dressing.

Results Point of Contact

Title: Dr. Fredrik Iredahl
Organization: Åby vårdcentral, County council of Östergötland

Study Officials

MD., PhD. Iredahl
Aby vardcentral, Region Ostergotland
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: No
Restrictive Agreement: No

Enrollment

5 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: CROSSOVER
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: MD, PhD.

Study Record Dates

First Submitted

February 26, 2018

First Posted

March 19, 2018

Study Start

May 28, 2018

Actual (reported)

Wound Dressing With Moisture Sensor

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (3)

Study Arms (2)

A-B-A

B-A-B

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Limitations and Caveats

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Documents

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (3)

Study Arms (2)

A-B-A

B-A-B

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Limitations and Caveats

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Documents

Locations