Clinical trial NCT02481284: Microcirculation of the Abdominal Skin After Deep Inferior Epigastric Artery Perforator Flap Procedure
Official title: Microcirculatory Evaluation of the Abdominal Skin in Breast Reconstruction With Deep Inferior Epigastric Artery Perforator Flap
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Reconstruction
Skin Perfusion
Keywords: Breast reconstruction
Deep inferior epigastric artery perforator flap
Skin perfusion
Plastic and reconstructive surgery
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2015-06-25
Enrollment: 20
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
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.

Brief summary: 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: 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).

Eligibility criteria: 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

Primary outcomes:
measure: Perfusion of the abdominal zones measured in mean perfusion units
timeFrame: Preoperative
measure: Perfusion of the abdominal zones measured in mean perfusion units
timeFrame: two hours (After raising the flap)
measure: Perfusion of the abdominal zones measured in mean perfusion units
timeFrame: Three hours (After undermining)
measure: Perfusion of the abdominal zones measured in mean perfusion units
timeFrame: Five hours (After abdominal closure)
measure: Perfusion of the abdominal zones measured in mean perfusion units
timeFrame: Postoperative day 1 (POD1)
measure: Perfusion of the abdominal zones measured in mean perfusion units
timeFrame: Postoperative day 3 (POD3)
measure: Perfusion of the abdominal zones measured in mean perfusion units
timeFrame: Postoperative day 7 (POD7)
Secondary outcomes:
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Department of Plastic and Reconstructive Surgery
Study officials:
affiliation: Oslo University Hospital
name: Kim A Tønseth, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: