Bioimpedance Based Monitoring of Operation Wound and Skin... | NCT02677285

Studies
Bioimpedance Based Monitoring of Operation Wound and Skin Graft Healing

NCT02677285

Sponsor

Tampere University Hospital

Status

Unknown status

Last Update Posted

Jun 28, 2018Actual

Enrollment

40Estimated

Phase

Not provided

Conditions

Skin Graft
Closed Operation Wound

Interventions

Different type of wound

Countries

Finland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2016

Primary Completion Date

Jun 2018Estimated

Completion Date

Jun 2018Estimated

First Submitted Date

Jan 25, 2016

First Submission Date that Met QC Criteria

Feb 3, 2016

First Posted Date

Feb 9, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 27, 2018

Last Update Posted Date

Jun 28, 2018Actual

Name	Class
Tampere University of Technology	OTHER
Åbo Akademi University	OTHER
Turku PET Centre	UNKNOWN
Tampere University

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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:

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Different type of wound	Other		Operation wound Skin graft

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Bioimpedance data	Bioimpedance values between selected measuring points with different frequencies	2 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients in Plastic surgery and KEI2 wards at Tampere University Hospital

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ilkka Kaartinen	Tampere University Hospital	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tampere University Hospital		Tampere		33521	Finland

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided