Bioimpedance Based Monitoring of Operation Wound and Skin Graft Healing

Skin Graft Clinical Trial

Official title:

Bioimpedance Based Monitoring of Operation Wound and Skin Graft Healing

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02677285
• Other study ID #: R150095
• Status: Enrolling by invitation
• Start date: January 2016
• Est. completion date: June 2018

Study information

• Verified date: June 2018
• Source: Tampere University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 40
• Est. completion date: June 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Closed Operation Wound
• Skin Graft
• Wounds and Injuries

Intervention

Other:
• Different type of wound

Locations

Country	Name	City	State
Finland	Tampere University Hospital	Tampere

Sponsors (5)

Lead Sponsor	Collaborator
Tampere University Hospital	Åbo Akademi University, Tampere University of Technology, Turku PET Centre, University of Tampere

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bioimpedance data	Bioimpedance values between selected measuring points with different frequencies	2 months