Skin GraftNCT02677285
Bioimpedance Based Monitoring of Operation Wound and Skin Graft Healing
An observational study of Skin Graft and Closed Operation Wound, run by Tampere University Hospital at 1 site in Finland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Skin Graft, Closed Operation Wound
- What is being tested?
- Different type of wound
- How many people
- 40 participants
- Where
- 1 siteFinland
- Study dates
- Jan 2016to Jun 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients in Plastic surgery and KEI2 wards at Tampere University Hospital
Who may be able to join
- 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
Who cannot join
- pregnancy
- patients with limited capacity to understand the information regarding the study
- patients with chronic skin disease on operation area
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Objectives of the study:
- The investigators will study how bioimpedance measurement results correlate with conventional wound healing monitoring.
- The investigators will seek the best methods for handling, interpreting and presenting bioimpedance measurement results.
- The investigators will find out if impedance measurement is applicable to clinical use.
- Conditions
- Skin Graft, Closed Operation Wound
- Being tested
- Different type of wound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Different type of woundOther
| Study group | Role | What they receive |
|---|---|---|
| Skin graft | The bioimpedance measurement is done with a purpose built patch that has electrodes in contact with the wound and reference electrodes. Receives: Other: Different type of wound | |
| Operation wound | The bioimpedance measurement is done with commercial electrodes places in healthy skin surrounding the wound. Receives: Other: Different type of wound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioimpedance data
Bioimpedance values between selected measuring points with different frequencies
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2016 (estimated)
- Study startJan 2016
- Primary completionJun 2018 (estimated)
- Study completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin GraftStudies of the same condition, open and under way.
- More trials run by Tampere University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tampere University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Tampere University of Technology, Åbo Akademi University, Turku PET Centre, Tampere University
- Responsible party
- Sponsor
- Investigators
- Ilkka Kaartinen, Study director, Tampere University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02677285
- Sponsor's protocol ID
- R150095
- Status last verified
- Jun 2018
- First submitted
- 25 Jan 2016
- Last updated
- 28 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioimpedance Based Monitoring of Operation Wound and Skin Graft Healing
- ClinicalTrials.gov ID
- NCT02677285
- Acronym / sponsor ID
- R150095
- Conditions
- Skin Graft, Closed Operation Wound
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Tampere University HospitalUniversity, hospital or other
- Collaborators
- Tampere University of Technology, Åbo Akademi University, Turku PET Centre, Tampere University
- Study start
- Jan 2016
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 9 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- The investigators will study how bioimpedance measurement results correlate with conventional wound healing monitoring.
- The investigators will seek the best methods for handling, interpreting and presenting bioimpedance measurement results.
- The investigators will find out if impedance measurement is applicable to clinical use.
Study design
- Observational model
- Case only
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Skin graft | – | Other: Different type of woundThe bioimpedance measurement is done with a purpose built patch that has electrodes in contact with the wound and reference electrodes. |
| Operation wound | – | Other: Different type of woundThe bioimpedance measurement is done with commercial electrodes places in healthy skin surrounding the wound. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients in Plastic surgery and KEI2 wards at Tampere University Hospital
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- pregnancy
- patients with limited capacity to understand the information regarding the study
- patients with chronic skin disease on operation area
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Different type of wound | Other | Operation wound, Skin graft |
Primary outcome
Bioimpedance data
Time frame: 2 months
Bioimpedance values between selected measuring points with different frequencies
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ilkka Kaartinen study director
Tampere University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Skin Graft and Closed Operation Wound, run by Tampere University Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bioimpedance data (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2018.