Clinical trial · Interventional
BENEFIT OF MECHANICAL ISCHEMIC PRECONDITIONING ON TOLERANCE OF ADIPOSE TISSUE TO ISCHEMIA REPERFUSION OF TYPE DIEP (DEEP INFERIOR EPIGASTRIC PERFORATOR) FREE FLAPS.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Mechanical ischemic preconditioning of diep-type flap | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Group intervention
- description
- PIM - DIEP
- interventionNames
- Procedure: Mechanical ischemic preconditioning of diep-type flap
Primary outcomes (1)
- measure
- Number of successes of the technique defined by the absence of pathological postoperative fat necrosis
- timeFrame
- 6 months post operation
- description
- 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
Secondary outcomes (6)
- measure
- to evaluate the efficacy of ischaemic preconditioning on the tolerance of the skin (cutaneous necrosis, scar separation) to the ischemia-reperfusion of DIEP flaps
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * female with age ≥ 18 * Secondary (unilateral or bilateral) * Signed consent form * Beneficiary of a social security scheme Exclusion Criteria: * 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
References
Publications (0)
Data not yet available