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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02481284
Other study ID # CAIngvaldsen
Secondary ID
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


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
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