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Completed

NCT Number: NCT02481284

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

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).

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Key information

Conditions

Breast Reconstruction Skin Perfusion

Sex eligibility

Female

Study type

Observational

Primary location

Department of Plastic and Reconstructive Surgery

Oslo, 0424, Norway

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Laser Doppler perfusion imaging

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.

Primary outcomes

  1. Perfusion of the abdominal zones measured in mean perfusion units

    Time frame: Preoperative

  2. Perfusion of the abdominal zones measured in mean perfusion units

    Time frame: two hours (After raising the flap)

  3. Perfusion of the abdominal zones measured in mean perfusion units

    Time frame: Three hours (After undermining)

  4. Perfusion of the abdominal zones measured in mean perfusion units

    Time frame: Five hours (After abdominal closure)

  5. Perfusion of the abdominal zones measured in mean perfusion units

    Time frame: Postoperative day 1 (POD1)

  6. Perfusion of the abdominal zones measured in mean perfusion units

    Time frame: Postoperative day 3 (POD3)

  7. Perfusion of the abdominal zones measured in mean perfusion units

    Time frame: Postoperative day 7 (POD7)

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2015
First posted
Jun 25, 2015
Registry last updated
Jun 25, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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