Fluorescence Angiography in the Assessment of DIEP Flap Perfusion

NCT02759796 | Completed DMC

• 1 other identifier: idipaz
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

It is a single-center, prospective, randomized and controlled study focused in microsurgical autologous breast reconstruction. It involves applying indocyanine green (ICG) angiography for the study of the vascularization of DIEP flaps. The aim of the study is to determine whether there are differences in complications and aesthetic results when ICG is used to discard the poorly vascularized areas of the flap. The study includes adult women undergoing unilateral DIEP flap breast reconstruction. The calculated sample size is 60 patients. There are two groups. In group 1, the investigators use the usual clinical criteria to discard the poorly vascularized areas of the flap. In group 2, the investigators use the ICG to shape the flap.

Conditions

Breast Cancer; Vascularization; Fat Necrosis

Outcome Measures

Primary Outcomes (2)

• Number of participants with fat necrosis as assessed by physical examination

  Six months postoperatively

• Number of participants with fat necrosis as assessed by ultrasonography

  Six months postoperatively

Secondary Outcomes (10)

• Number of participants with flap failure as assessed by physical examination

  From intraoperative moment to one week postoperatively

• Number of participants with wound infection as assessed by physical examination

  From one day postoperatively to two weeks postoperatively

• Number of participants with wound healing delay as assessed by physical examination

  From two weeks postoperatively to two months postoperatively

• Number of participants with reoperation

  From immediate postoperative moment to one year postoperatively

• Flap perfusion index as assessed by IC-CALC software (Pulsion Medical System)

  Intraoperatively

Study Arms (2)

Clinical assessment of flap perfusion

PLACEBO COMPARATOR

Tailoring the flap according to clinical assessment of flap perfusion

Procedure: Tailoring the flap according to clinical assessment

Angiography assessment of flap perfusion

EXPERIMENTAL

Tailoring the flap according to ICG Angiography assessment of flap perfusion

Procedure: Tailoring the flap according to ICG Angiography assessment

Interventions

Tailoring the flap according to clinical assessment PROCEDURE

After microvascular anastomosis is performed, the investigators clinically assess flap vascularization and the well vascularized tissue is marked by means of a dermographic pencil. Then the investigators administer 0,2mg/kg of ICG intravenously. The vascularization of the flap is also checked by means of the Photo Dynamic Eye (Pulsion Medical System) but finally the decision of discarding the poorly vascularized areas of the flap is made by clinical assessment.

Clinical assessment of flap perfusion

Tailoring the flap according to ICG Angiography assessment PROCEDURE

After microvascular anastomosis is performed, the investigators administer 0,2mg/kg of ICG intravenously. Then the investigators check the vascularization of the flap by means of the Photo Dynamic Eye (Pulsion Medical System) and the poorly vascularized areas of the flap are discarded guided by ICG perfusion test.

Angiography assessment of flap perfusion

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Mastectomized adult female patient
• Abdominal flap unilateral breast reconstruction indication
• Alloplastic breast reconstruction sequelae
• Enough amount of abdominal dermofat tissue to shape a breast with a primary closure of the donor site

You may not qualify if:

• DIEP flap bilateral breast reconstruction indication
• Previous abdominoplasty surgery
• Untreated psychiatric disease
• Untreated infection
• Indocyanine green or iodine hypersensitivity
• Hyperthyroidism, thyroid adenoma or thyroid autonomy
• Any concomitant disease or condition that, in the opinion of the investigator, can make the patient unsuitable to receive a microsurgical technique or to join the research.

Sponsors & Collaborators

• Instituto de Investigación Hospital Universitario La Paz: lead

Study Sites (1)

La Paz University Hospital

Madrid, 28046, Spain

Location

Related Publications (1)

• Varela R, Casado-Sanchez C, Zarbakhsh S, Diez J, Hernandez-Godoy J, Landin L. Outcomes of DIEP Flap and Fluorescent Angiography: A Randomized Controlled Clinical Trial. Plast Reconstr Surg. 2020 Jan;145(1):1-10. doi: 10.1097/PRS.0000000000006393.

  PMID: 31577664 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Neovascularization, Pathologic; Fat Necrosis

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Metaplasia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Luis Landín Jarillo, MD, PhD

  La Paz University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2016
• First Posted: May 3, 2016
• Study Start: November 1, 2015
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2017
• Last Updated: April 24, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)