Microcirculatory Evaluation of the Abdominal Skin in Breast Reconstruction With Deep Inferior Epigastric Artery Perforator Flap
Sponsor study identifier
observational
20
1 country
1
Study Start
January 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
September 2009
Actual (reported)Study Completion
March 2015
Actual (reported)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).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2015
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2008
Date type not reportedThis date has not been verified as actual or estimated.
September 2009
Actual (reported)March 2015
Actual (reported)May 11, 2015
Actual (reported)June 25, 2015
Actual (reported)Perfusion of the abdominal zones measured in mean perfusion units
Preoperative
Perfusion of the abdominal zones measured in mean perfusion units
two hours (After raising the flap)
Perfusion of the abdominal zones measured in mean perfusion units
Three hours (After undermining)
Perfusion of the abdominal zones measured in mean perfusion units
Five hours (After abdominal closure)
Perfusion of the abdominal zones measured in mean perfusion units
Postoperative day 1 (POD1)
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
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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.
Department of Plastic and Reconstructive Surgery
Oslo, Oslo, 0424, Norway
Kim A Tønseth, MD, PhD
Oslo University Hospital
20 participants (actual enrollment reported by the registry).
First Submitted
May 11, 2015
First Posted
June 25, 2015
Study Start
January 2008
Date type not reportedThis date has not been verified as actual or estimated.
A Bilateral Interconnected DIEP Flap Based on One Vessel Pedicle for Breast Reconstruction
Perfusion of the abdominal zones measured in mean perfusion units
Postoperative day 3 (POD3)
Perfusion of the abdominal zones measured in mean perfusion units
Postoperative day 7 (POD7)
Contact the study team to confirm eligibility.
Primary Completion
September 2009
Actual (reported)Study Completion
March 2015
Actual (reported)Last Updated
June 25, 2015
Record last verified: 2015-06
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Source: ClinicalTrials.gov.
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