ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02481284
Recruitment Status : Completed
First Posted : June 25, 2015
Last Update Posted : June 25, 2015
Sponsor:
Information provided by (Responsible Party):
Kim Alexander Tønseth, Oslo University Hospital

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).


Condition or disease Intervention/treatment
Breast Reconstruction Skin Perfusion Device: Laser Doppler perfusion imaging

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).


Study Type : Observational
Actual Enrollment : 20 participants
Time Perspective: Prospective
Official Title: Microcirculatory Evaluation of the Abdominal Skin in Breast Reconstruction With Deep Inferior Epigastric Artery Perforator Flap
Study Start Date : January 2008
Actual Primary Completion Date : September 2009
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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
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.




Primary Outcome Measures :
  1. Perfusion of the abdominal zones measured in mean perfusion units [ Time Frame: Preoperative ]
  2. Perfusion of the abdominal zones measured in mean perfusion units [ Time Frame: two hours (After raising the flap) ]
  3. Perfusion of the abdominal zones measured in mean perfusion units [ Time Frame: Three hours (After undermining) ]
  4. Perfusion of the abdominal zones measured in mean perfusion units [ Time Frame: Five hours (After abdominal closure) ]
  5. Perfusion of the abdominal zones measured in mean perfusion units [ Time Frame: Postoperative day 1 (POD1) ]
  6. Perfusion of the abdominal zones measured in mean perfusion units [ Time Frame: Postoperative day 3 (POD3) ]
  7. Perfusion of the abdominal zones measured in mean perfusion units [ Time Frame: Postoperative day 7 (POD7) ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02481284


Locations
Norway
Department of Plastic and Reconstructive Surgery
Oslo, Norway, 0424
Sponsors and Collaborators
Oslo University Hospital
Investigators
Principal Investigator: Kim A Tønseth, MD, PhD Oslo University Hospital

Responsible Party: Kim Alexander Tønseth, Head of Department, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT02481284     History of Changes
Other Study ID Numbers: CAIngvaldsen
First Posted: June 25, 2015    Key Record Dates
Last Update Posted: June 25, 2015
Last Verified: June 2015

Keywords provided by Kim Alexander Tønseth, Oslo University Hospital:
Breast reconstruction
Deep inferior epigastric artery perforator flap
Skin perfusion
Plastic and reconstructive surgery