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

Breast Reconstruction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02481284
• Other study ID #: CAIngvaldsen
• Status: Completed
• Phase: N/A
• First received: May 11, 2015
• Last updated: June 22, 2015
• Start date: January 2008
• Est. completion date: March 2015

Study information

• Verified date: June 2015
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Regional Ethics Commite
• Study type: Observational

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 2015
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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 Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Reconstruction
• Skin Perfusion

Intervention

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.

Locations

Country	Name	City	State
Norway	Department of Plastic and Reconstructive Surgery	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Perfusion of the abdominal zones measured in mean perfusion units		Preoperative	No
Primary	Perfusion of the abdominal zones measured in mean perfusion units		two hours (After raising the flap)	No
Primary	Perfusion of the abdominal zones measured in mean perfusion units		Three hours (After undermining)	No
Primary	Perfusion of the abdominal zones measured in mean perfusion units		Five hours (After abdominal closure)	No
Primary	Perfusion of the abdominal zones measured in mean perfusion units		Postoperative day 1 (POD1)	No
Primary	Perfusion of the abdominal zones measured in mean perfusion units		Postoperative day 3 (POD3)	No
Primary	Perfusion of the abdominal zones measured in mean perfusion units		Postoperative day 7 (POD7)	No