Breast CancerPRIMIDIEPNCT05373069
BENEFIT OF MECHANICAL ISCHEMIC PRECONDITIONING ON TOLERANCE OF ADIPOSE TISSUE TO ISCHEMIA REPERFUSION OF TYPE DIEP (DEEP INFERIOR EPIGASTRIC PERFORATOR) FREE FLAPS.
A study testing Mechanical ischemic preconditioning of diep-type flap in people with Breast Cancer, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Mechanical ischemic preconditioning of diep-type flap
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteFrance
- Study dates
- 1 Feb 2023to 10 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- female with age ≥ 18
- Secondary (unilateral or bilateral)
- Signed consent form
- Beneficiary of a social security scheme
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Service Plastique, Reconstruction, Esthétique, Hôpital TENON- APHP
Paris, 75020
About this study
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.
Read more
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.
Read the detailed description
This is a phase 2 monocentric study, following the 2 step Simon Minimax design.
We will be carrying out cycles of ischemic preconditioning for 40 minutes, simulating 2 cycles of ischemia-reperfusion (per 10min) prior to flap harvesting and cold ischemia before revascularization.
The pre operation visit will occur between M3 and M1 before the scheduled operation date. The visit will be carried out by the surgeon who will inform the patient of the study.
The inclusion visit (D0) will be carried out by the investigator the day before surgery (collection of signed consent form). The surgery will be carried out as usual: breast reconstruction with DIEP type flap. Modification of the intervention for the study: preconditioning of the flap (for patients) and 3 biopsies.
During post-operative hospitalization, usual visits will be carried out twice a day (not specifically for the study) by an doctor (to check for vascular damage, hematoma, infection, cutaneous necrosis, leakage and scar separation).
After postoperative discharge, 4 follow up visits are planned which correspond to 3 postoperative consultations at the hospital (to check for vascular damage, hematoma, infection, cutaneous necrosis, leakage and scar separation) at D21 (+/- 2 days), M1 (+/- 2 days), M3 (+/- 15 days, same assessment plus search for palpable, painful or deforming nodules) and M6 (+/- 15 days, last visit) plus a mammary ultrasound (this is the only supplementary assessment carried out for the study, Tenon hospital).
- Conditions
- Breast Cancer
- Being tested
- Mechanical ischemic preconditioning of diep-type flap
- Keywords
- Breast reconstruction, Ischaemic preconditioning, DIEP flap
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mechanical ischemic preconditioning of diep-type flapProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Group intervention | Experimental | PIM - DIEP Receives: Procedure: Mechanical ischemic preconditioning of diep-type flap |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
proportion of patients with skin necrosis
Measured: 6 months post operation
Presence of skin necrosis within 6 months postoperatively defined by (occurrence of one or more of the three subcited elements
- Skin infection
- Skin necrosis of the flap
- Scar disunion
Measured: 6 months post operation
Proportion of overall reconstruction failures: postoperative flap loss at M6: flap removal for total necrosis
Measured: 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)
Measured: 6 months post operation
to evaluate the proportion of overall failure after DIEP type flaps.
Proportion of overall reconstruction failure (need to remove the flap for total necrosis)
Measured: 6 months post operation
to evaluate the proportion of subclinical cytosteatonecrosis
rate of subclinical cysteatonecrosis
Measured: 6 months post operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2022
- Study start1 Feb 2023
- Primary completion10 Jun 2025
- Study completion10 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- INSERM Bichat hospital
- Responsible party
- Sponsor
- Investigators
- Sarra CRISTOFARI, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05373069
- Sponsor's protocol ID
- APHP201173
- Other IDs
- 2021-A00173-38
- Acronym
- PRIMIDIEP
- Status last verified
- Aug 2025
- First submitted
- 4 Mar 2022
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BENEFIT OF MECHANICAL ISCHEMIC PRECONDITIONING ON TOLERANCE OF ADIPOSE TISSUE TO ISCHEMIA REPERFUSION OF TYPE DIEP (DEEP INFERIOR EPIGASTRIC PERFORATOR) FREE FLAPS.
- ClinicalTrials.gov ID
- NCT05373069
- Acronym / sponsor ID
- PRIMIDIEP / APHP201173
- Conditions
- Breast Cancer
- Keywords
- Breast reconstruction, Ischaemic preconditioning, DIEP flap
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- INSERM Bichat hospital
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 10 Jun 2025 (actual)
- Study completion
- 10 Jun 2025 (actual)
- First posted
- 13 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a phase 2 monocentric study, following the 2 step Simon Minimax design.
We will be carrying out cycles of ischemic preconditioning for 40 minutes, simulating 2 cycles of ischemia-reperfusion (per 10min) prior to flap harvesting and cold ischemia before revascularization.
The pre operation visit will occur between M3 and M1 before the scheduled operation date. The visit will be carried out by the surgeon who will inform the patient of the study.
The inclusion visit (D0) will be carried out by the investigator the day before surgery (collection of signed consent form). The surgery will be carried out as usual: breast reconstruction with DIEP type flap. Modification of the intervention for the study: preconditioning of the flap (for patients) and 3 biopsies.
During post-operative hospitalization, usual visits will be carried out twice a day (not specifically for the study) by an doctor (to check for vascular damage, hematoma, infection, cutaneous necrosis, leakage and scar separation).
After postoperative discharge, 4 follow up visits are planned which correspond to 3 postoperative consultations at the hospital (to check for vascular damage, hematoma, infection, cutaneous necrosis, leakage and scar separation) at D21 (+/- 2 days), M1 (+/- 2 days), M3 (+/- 15 days, same assessment plus search for palpable, painful or deforming nodules) and M6 (+/- 15 days, last visit) plus a mammary ultrasound (this is the only supplementary assessment carried out for the study, Tenon hospital).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group intervention | Experimental | Procedure: Mechanical ischemic preconditioning of diep-type flapPIM - DIEP |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- female with age ≥ 18
- Secondary (unilateral or bilateral)
- Signed consent form
- Beneficiary of a social security scheme
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mechanical ischemic preconditioning of diep-type flapMechanical 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. | Procedure or surgery | Group intervention |
Primary outcome
Number of successes of the technique defined by the absence of pathological postoperative fat necrosis
Time frame: 6 months post operation
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 secondary outcomes
to evaluate the efficacy of ischaemic preconditioning on the tolerance of the skin (cutaneous necrosis, scar separation) to the ischemia-reperfusion of DIEP flaps
Time frame: 6 months post operation
Presence of skin necrosis within 6 months postoperatively defined by (occurrence of one or more of the three subcited elements
Time frame: 6 months post operation
Proportion of overall reconstruction failures: postoperative flap loss at M6: flap removal for total necrosis
Time frame: 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)
Time frame: 6 months post operation
to evaluate the proportion of overall failure after DIEP type flaps.
Time frame: 6 months post operation
to evaluate the proportion of subclinical cytosteatonecrosis
Time frame: 6 months post operation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarra CRISTOFARI, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mechanical ischemic preconditioning of diep-type flap in people with Breast Cancer, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of successes of the technique defined by the absence of pathological postoperative fat necrosis (time frame: 6 months post operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2026.