Bioimpedance Based Monitoring of Operation Wound and Skin Graft Healing

• Conditions: Skin Graft; Closed Operation Wound
• Interventions: Other: Different type of wound

• Registration Number: NCT02677285
• Lead Sponsor: Tampere University Hospital

Brief Summary

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

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 Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-01-25
• Study First Submitted QC: 2016-02-03
• Study First Posted: 2016-02-09
• Status Verified: 2018-06
• Primary Completion: 2018-06
• Study Completion: 2018-06
• Last Update Submitted: 2018-06-27
• Last Update Posted: 2018-06-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Bioimpedance data	2 months	Bioimpedance values between selected measuring points with different frequencies

Trial Locations

Locations (1)

Tampere University Hospital; 🇫🇮 Tampere, Finland