Clinical Study of Moisture Sensor Dressing Used for Exuding Wounds

NCT04890769 | Terminated

• 1 other identifier: 0007-P--047
• Study Type: observational
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

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

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)

Study Arms (1)

Participants

Patients with exuding wounds

Device: Moisture sensor wound dressing

Interventions

Moisture sensor wound dressing DEVICE

Clinical procedure for change of wound dressing

Also known as: DryMax Sensor

Participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients from primary health care

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fredrik Iredahl: lead
• Primary Health Care Center, Department of Health Medicine and Caring Sciences, Linköping University, Linköping, Sweden: collaborator

Study Sites (1)

Primary Health Care Center in Österlötland

Linköping, Sweden

Location

MeSH Terms

Conditions

Leg Ulcer; Wounds and Injuries

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Fredrik Iredahl, MD. PhD.

  Linkoeping University

  PRINCIPAL INVESTIGATOR

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
• Primary Completion: February 22, 2022
• Study Completion: February 22, 2022
• Last Updated: March 18, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)