BENEFIT OF MECHANICAL ISCHEMIC PRECONDITIONING ON TOLERANCE OF ADIPOSE TISSUE TO ISCHEMIA REPERFUSION OF TYPE DIEP (DEEP INFERIOR EPIGASTRIC PERFORATOR) FREE FLAPS.

NCT05373069 | Completed DMC

• 2 other identifiers: APHP2011732021-A00173-38
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

Breast cancer is the most common cancer amongst women in terms of frequency, with more than 50 000 newly diagnosed cases per year in France. The average 5-year survival rate for women with breast cancer is around 85%. Surgical treatment by total mastectomy concerns around 30% of cases. For patients who have been treated for breast cancer by total mastectomy, secondary breast reconstructions are often carried out via excess abdominal fat flaps of DIEP type. Postoperative partial fat necrosis is a common complication of breast reconstruction. This necrosis is qualified as pathological when it is palpable or when there are symptoms leading to pain, deformation, or leakage. Necrosis occurs in the first 6 months after surgery. Diagnosis is carried out by the detection of a nodule of fat necrosis measuring at least 5 mm on the ultrasound. Partial flat necrosis results from ischemia reperfusion (IR) to the fat tissues during reconstruction. IR leads to inflammatory lesions, edema, capillary occlusion that can lead to tissue necrosis. The deleterious impact of IR has been shown on the organs (liver, kidney) on muscular, cutaneous and adipose tissues in humans and animals. Ischaemic preconditioning is a procedure used in organ transplant surgery, allowing a better tolerance of the graft for ischemia reperfusion, without further complications. It is used in usual practice for kidney or liver transplants; short cycles of ischemia reperfusion are carried out on the organ pedicle before harvesting using cold ischemia (out of the donor's body) pre-transplant. Ischaemic preconditioning before reconstruction has been studied in animal models but not in human reconstruction surgery, although it seems to be beneficial. For patients undergoing total mastectomy after being diagnosed with breast cancer, we hypothesize that ischaemic preconditioning, usually used for organ transplants, could decrease adipose tissue lesions caused by ischemia reperfusion after breast reconstruction with DIEP (deep inferior epigastric perforator) flaps.

Conditions

Breast Cancer

Keywords

Breast reconstruction; Ischaemic preconditioning; DIEP flap

Outcome Measures

Primary Outcomes (1)

• Number of successes of the technique defined by the absence of pathological postoperative fat necrosis

  Number of successes of the technique defined by the absence of pathological postoperative fat necrosis to evaluate the efficacy of ischaemic preconditioning on the tolerance of the adipose tissue to the ischemia-reperfusion of DIEP flaps

  6 months post operation

Secondary Outcomes (6)

• to evaluate the efficacy of ischaemic preconditioning on the tolerance of the skin (cutaneous necrosis, scar separation) to the ischemia-reperfusion of DIEP flaps

  6 months post operation

• Presence of skin necrosis within 6 months postoperatively defined by (occurrence of one or more of the three subcited elements

  6 months post operation

• Proportion of overall reconstruction failures: postoperative flap loss at M6: flap removal for total necrosis

  6 months post operation

• Rate of subclinical cystosteatonecrosis (detected by ultrasound at M6: presence of one or more nodules, measuring more than 5mm but having no clinical repercussions)

  6 months post operation

• to evaluate the proportion of overall failure after DIEP type flaps.

  6 months post operation

Study Arms (1)

Group intervention

EXPERIMENTAL

PIM - DIEP

Procedure: Mechanical ischemic preconditioning of diep-type flap

Interventions

Mechanical ischemic preconditioning of diep-type flap PROCEDURE

Mechanical ischemic preconditioning: Performing series of reperfusion ischemia on the flap pedicle, before cold ischemia of the flap (flap harvesting before vascular mechanical anastomoses at the recipient site) * 10 min of clamping with single-use microvascular forceps * 10 min declamping * 10 min of tightening with pliers * 10 min declamping Either preconditioning for 40 minutes, simulating 2 cycles of ischemia reperfusion prior to flap harvesting and cold ischemia before revascularization.

Group intervention

Eligibility Criteria

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

You may qualify if:

• female with age ≥ 18
• Secondary (unilateral or bilateral)
• Signed consent form
• Beneficiary of a social security scheme

You may not qualify if:

• Smoking: active contraindication for flap surgery
• Pregnancy: contraindication for surgery
• Immediate breast reconstruction, at the same time as the mastectomy (increases cutaneous complications and different surgical technique)
• Bilateral breast reconstruction (increases operation time and post operation complications)
• Patient under curatorship or guardianship
• Patient deprived of their liberty, and patient undergoing psychiatric care
• Risk factor for DIEP complication such as: previous surgical procedures performed on the abdomen, carcinological treatments and severe comorbidities of the patient.
• Risk factors for complications of mechanical preconditioning. Soft tissue inflammation or osteomyelitis, peripheral arterial occlusive disease, vasculitis,
• Participation in another interventional study
• Any contraindication to general anesthesia

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• INSERM Bichat hospital: collaborator

Study Sites (1)

Service Plastique, Reconstruction, Esthétique, Hôpital TENON- APHP

Paris, 75020, France

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Sarra CRISTOFARI, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2022
• First Posted: May 13, 2022
• Study Start: February 1, 2023
• Primary Completion: June 10, 2025
• Study Completion: June 10, 2025
• Last Updated: March 13, 2026

Record last verified: 2025-08

Locations

FR (1)