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

June 22, 2015 updated by: Kim Alexander Tønseth, Oslo University Hospital

Microcirculatory Evaluation of the Abdominal Skin in Breast Reconstruction With Deep Inferior Epigastric Artery Perforator Flap

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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).

Study Type

Observational

Enrollment (Actual)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Oslo, Norway, 0424
        • Department of plastic and reconstructive Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

20 women consecutively undergoing secondary, unilateral breast reconstruction with a DIEAP flap were identified and recruited to participate in the study. The patients were informed about of risks and benefits and gave written consent prior to participation. All smokers stopped smoking 4 weeks prior to surgery.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Perfusion of the abdominal zones measured in mean perfusion units
Time Frame: Preoperative
Preoperative
Perfusion of the abdominal zones measured in mean perfusion units
Time Frame: two hours (After raising the flap)
two hours (After raising the flap)
Perfusion of the abdominal zones measured in mean perfusion units
Time Frame: Three hours (After undermining)
Three hours (After undermining)
Perfusion of the abdominal zones measured in mean perfusion units
Time Frame: Five hours (After abdominal closure)
Five hours (After abdominal closure)
Perfusion of the abdominal zones measured in mean perfusion units
Time Frame: Postoperative day 1 (POD1)
Postoperative day 1 (POD1)
Perfusion of the abdominal zones measured in mean perfusion units
Time Frame: Postoperative day 3 (POD3)
Postoperative day 3 (POD3)
Perfusion of the abdominal zones measured in mean perfusion units
Time Frame: Postoperative day 7 (POD7)
Postoperative day 7 (POD7)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oslo University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (ACTUAL)

September 1, 2009

Study Completion (ACTUAL)

March 1, 2015

Study Registration Dates

First Submitted

May 11, 2015

First Submitted That Met QC Criteria

June 22, 2015

First Posted (ESTIMATE)

June 25, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

June 25, 2015

Last Update Submitted That Met QC Criteria

June 22, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CAIngvaldsen

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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