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

NCT02481284 | Completed

• 1 other identifier: CAIngvaldsen
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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).

Conditions

Breast Reconstruction; Skin Perfusion

Keywords

Breast reconstruction; Deep inferior epigastric artery perforator flap; Skin perfusion; Plastic and reconstructive surgery

Outcome Measures

Primary Outcomes (7)

• 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)

• 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)

Study Arms (1)

Laser Doppler Perfusion Imaging

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

Device: Laser Doppler perfusion imaging

Interventions

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.

Laser Doppler Perfusion Imaging

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Secondary, unilateral breast reconstruction with a DIEAP
• All smokers stopped smoking 4 weeks prior to surgery

You may not qualify if:

• Metastatic disease
• Bilateral breast reconstruction

Sponsors & Collaborators

• Oslo University Hospital: lead

Study Sites (1)

Department of Plastic and Reconstructive Surgery

Oslo, Oslo County, 0424, Norway

Location

Study Officials

• Kim A Tønseth, MD, PhD

  Oslo University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Department

Study Record Dates

• First Submitted: May 11, 2015
• First Posted: June 25, 2015
• Study Start: January 1, 2008
• Primary Completion: September 1, 2009
• Study Completion: March 1, 2015
• Last Updated: June 25, 2015

Record last verified: 2015-06

Locations

NO (1)