Bioimpedance Based Monitoring of Operation Wound and Skin Graft Healing

June 27, 2018 updated by: Tampere University Hospital

This study consists of two clinical series. With the first series investigators monitor the healing of skin grafts with bioimpedance measurements. The bioimpedance measurement is done with a purpose built patch that has electrodes in contact with the wound and reference electrodes.

In the second series the investigators monitor closed operational wounds (breast reconstruction surgery patients) with bioimpedance measurements. This series is also conducted with bioimpedance measurements but the wounds are operational wounds.

Both groups will have 20 patients.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Objectives of the study:

  1. The investigators will study how bioimpedance measurement results correlate with conventional wound healing monitoring.
  2. The investigators will seek the best methods for handling, interpreting and presenting bioimpedance measurement results.
  3. The investigators will find out if impedance measurement is applicable to clinical use.

Study Type

Observational

Enrollment (Anticipated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Tampere, Finland, 33521
        • Tampere University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients in Plastic surgery and KEI2 wards at Tampere University Hospital

Description

Inclusion Criteria:

  • patients that have a skin graft operation made as part of their treatment
  • patients that have breast reconstruction surgery made as part of their treatment

Exclusion Criteria:

  • pregnancy
  • patients with limited capacity to understand the information regarding the study
  • patients with chronic skin disease on operation area

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Skin graft
The bioimpedance measurement is done with a purpose built patch that has electrodes in contact with the wound and reference electrodes.
Other: Different type of wound
Operation wound
The bioimpedance measurement is done with commercial electrodes places in healthy skin surrounding the wound.
Other: Different type of wound

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bioimpedance data
Time Frame: 2 months
Bioimpedance values between selected measuring points with different frequencies
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tampere University Hospital

Collaborators

Tampere University
Tampere University of Technology
Åbo Akademi University
Turku PET Centre

Investigators

  • Study Director: Ilkka Kaartinen, Tampere University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Anticipated)

June 1, 2018

Study Completion (Anticipated)

June 1, 2018

Study Registration Dates

First Submitted

January 25, 2016

First Submitted That Met QC Criteria

February 3, 2016

First Posted (Estimate)

February 9, 2016

Study Record Updates

Last Update Posted (Actual)

June 28, 2018

Last Update Submitted That Met QC Criteria

June 27, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R150095

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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