Microcirculation of the Abdominal Skin After Deep Inferior Epigastric Artery Perforator Flap Procedure

NCT ID: NCT02481284

Last Updated: 2015-06-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-01-31

Study Completion Date

2015-03-31

Brief Summary

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The purpose of this study was to perform a quantitative perfusion study of the undermined abdominal skin in deep inferior epigastric artery perforator flap breast reconstruction patients in order to obtain more knowledge on perfusion dynamics. Laser Doppler perfusion imaging (LDPI) was used to evaluate this.

Microcirculatory changes were monitored in the abdominal skin of 20 consecutive patients. Measurements were taken and recorded within four standardized zones covering the skin between the xiphoid process and the upper incisional boundary of the flap (zone 1-4; cranial to caudal).

Detailed Description

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Background: No studies have assessed the perfusion of the undermined abdominal skin in breast reconstruction with deep inferior epigastric artery perforator flap. A greater understanding of the procedure's impact on the perfusion of the abdominal skin can be valuable in predicting areas susceptible to necrosis.

Methods: Microcirculatory changes were monitored in the abdominal skin of 20 consecutive patients undergoing breast reconstruction with a deep inferior epigastric artery perforator flap. Quantitative mapping was performed with laser Doppler perfusion imaging at seven set intervals. Measurements were taken and recorded within four standardized zones covering the skin between the xiphoid process and the upper incisional boundary of the flap (zone 1-4; cranial to caudal).

Conditions

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Breast Reconstruction Skin Perfusion

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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Laser Doppler Perfusion Imaging

20 consequetive cases undergoing breast reconstruction with Deep inferior epigastric artery perforator flap who had evaluation of the microcirculation of the abdominal skin with laser Doppler perfusion imaging

Laser Doppler perfusion imaging

Intervention Type DEVICE

LDPI is an extension of laser Doppler flowmetry (LDF) and was developed to generate a colour-coded perfusion image in a large area of skin.

Interventions

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Laser Doppler perfusion imaging

LDPI is an extension of laser Doppler flowmetry (LDF) and was developed to generate a colour-coded perfusion image in a large area of skin.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Secondary, unilateral breast reconstruction with a DIEAP
* All smokers stopped smoking 4 weeks prior to surgery

Exclusion Criteria

* Metastatic disease
* Bilateral breast reconstruction
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Oslo University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Kim Alexander Tønseth

Head of Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kim A Tønseth, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Oslo University Hospital

Locations

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Department of Plastic and Reconstructive Surgery

Oslo, Oslo County, Norway

Site Status

Countries

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Norway

Other Identifiers

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CAIngvaldsen

Identifier Type: -

Identifier Source: org_study_id

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