Bioimpedance Based Monitoring of Operation Wound and Skin Graft Healing

NCT ID: NCT02677285

Last Updated: 2018-06-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-01-31

Study Completion Date

2018-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Skin Graft Closed Operation Wound

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

OTHER

Study Groups

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Skin graft

The bioimpedance measurement is done with a purpose built patch that has electrodes in contact with the wound and reference electrodes.

Different type of wound

Intervention Type OTHER

Operation wound

The bioimpedance measurement is done with commercial electrodes places in healthy skin surrounding the wound.

Different type of wound

Intervention Type OTHER

Interventions

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Different type of wound

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tampere University of Technology

OTHER

Sponsor Role collaborator

Åbo Akademi University

OTHER

Sponsor Role collaborator

Turku PET Centre

UNKNOWN

Sponsor Role collaborator

Tampere University

OTHER

Sponsor Role collaborator

Tampere University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ilkka Kaartinen

Role: STUDY_DIRECTOR

Tampere University Hospital

Locations

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Tampere University Hospital

Tampere, , Finland

Site Status

Countries

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Finland

Other Identifiers

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R150095

Identifier Type: -

Identifier Source: org_study_id

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