NCT02677285

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

January 25, 2016

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 9, 2016

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

June 28, 2018

Status Verified

June 1, 2018

Enrollment Period

2.4 years

First QC Date

January 25, 2016

Last Update Submit

June 27, 2018

Conditions

Skin GraftClosed Operation Wound

Outcome Measures

Primary Outcomes (1)

  • Bioimpedance data

    Bioimpedance values between selected measuring points with different frequencies

    2 months

Study Arms (2)

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

Interventions

Different type of woundOTHER
Operation woundSkin graft

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients in Plastic surgery and KEI2 wards at Tampere University Hospital

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tampere University Hospital

Tampere, 33521, Finland

Location

Study Officials

  • Ilkka Kaartinen

    Tampere University Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2016

First Posted

February 9, 2016

Study Start

January 1, 2016

Primary Completion

June 1, 2018

Study Completion

June 1, 2018

Last Updated

June 28, 2018

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will not share

Locations

FI(1)