Breast Cancer SurgeryS-DIEPNCT06930378
Improvement in Breast Skin Sensibility After Breast Reconstruction: a Comparison of 3 Surgical Techniques
A study testing Nerve Suture in people with Breast Cancer Surgery and Reconstruction Breast Surgery, run by Patricia Esther Engels at 1 site in Switzerland.
Trial summary
The goal of this clinical trial is to learn if nerve sutures in free flap breast reconstruction can optimize sensibility in the reconstructed breast in patients opting for DIEP flap breast reconstruction due to breast cancer or genetic conditions. Affected women 18 to 80 years old can be included. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Breast Cancer Surgery, Reconstruction Breast Surgery, Sensitization
- What is being tested?
- Nerve Suture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteSwitzerland
- Study dates
- Apr 2025to Feb 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-80 years old
- having received DIEP flap breast reconstruction with a flap not completely buried
- having given written informed consent for participating in the study
- 18 to 80 years old
- having given written informed consent for participating in the study
- receiving immediate or delayed unilateral DIEP breast reconstruction with a DIEP flap which will not be completely buried
Who cannot join
- postoperative radiotherapy on the flap
- neurological conditions as diabetic neuropathy, alcoholism or any other severe underlying peripheral neuropathy including chemotherapy-induced neuropathy or neuropathy induced by other medications
- active smoking
- language barrier
- pregnancy or lactating women
- Main study
Show all 13Show fewer
- autologous reconstruction where the flap is completely buried
- patients in need of both-sided reconstruction (double DIEP)
- postoperative radiotherapy on the flap
- neurological conditions as diabetic neuropathy, alcoholism, or any other severe underlying peripheral neuropathy including chemotherapy-induced neuropathy or neuropathy induced by other medications
- active smoking
- language barrier
- pregnancy at time of planned DIEP flap surgery and lactation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Geneva University Hospitals
Geneva, Canton of Geneva, 1205
Patricia E Engels, MD, +41795537557, patricia.engels@hug.ch
Axelle Serre, MD, +41795538642, axelle.serre@hug.de
About this study
Official title: Sensory Restoration in DIEP Free Flaps for Post-Mastectomy Breast Reconstruction After Breast Cancer: Comparing Non-sensitized Standard Technique to Direct Nerve Suture and to Autograft: A Three-arm, Randomized, Double-blinded Superiority Trial
The goal of this clinical trial is to learn if nerve sutures in free flap breast reconstruction can optimize sensibility in the reconstructed breast in patients opting for DIEP flap breast reconstruction due to breast cancer or genetic conditions. Affected women 18 to 80 years old can be included. The main question is:
If a nerve suture was carried out, can pressure be felt better on the reconstructed breast after 12 months? If a nerve suture was carried out, will better sensibility and quality of life be felt and perceived (questionnaire) at 12 and 24 months after the initial operation ? Researchers will compare two different nerve suture techniques and no nerve suture to one another to see if and which nerve suture optimizes sensibility.
Read more
Participants will have regular visits and follow-up controls, during which
- their sensibility will be tested multimodally,
- they will fill out questionnaires
- skin biopsies will be taken.
Read the detailed description
Breast reconstruction with autologous tissue is one of the most important methods: The DIEP (deep inferior epigastric artery perforator) flap is today's workhorse in autologous reconstruction. Routinely, the arteries and veins of the donor- and recipient sites are connected, but not the nerves. The sensory recovery is an undervalued aspect despite the disadvantages of insensate flaps. Connection of the abdominal flap skin's nerves to the breast region's nerves allows sensitized reconstruction. The research project aims to make sensitized flap-based breast reconstruction the standard method by proving its superiority, using the sensory testing with Semmes-Weinstein-Monofilament (pressure threshold) as the primary outcome measured before surgery and 12 months post-surgery. Therefore, patients will be randomized in three groups:
- sensitization with direct nerve suture or
- autograft or
- no sensitization. Moreover, no previous studies have analyzed the potential changes in flap skin with proteomics, thus justifying our secondary objective.
The hypothesis is that flaps with nerve suture(s) have better sensibility. The main outcome will be the sensory testing (pressure threshold). As secondary outcomes the questionnaire will show the patients' quality of life, and the proteomic analysis, should, according to our hypothesis, show that quantity and expression of the proteins of flap skin with nerve suture are closer to normal skin than without nerve suture.
- Conditions
- Breast Cancer Surgery, Reconstruction Breast Surgery, Sensitization, DIEP Flap Breast Reconstruction
- Being tested
- Nerve Suture
- Keywords
- free flap, breast reconstruction, autologous-based reconstruction, neurotization, sensory recovery, post-mastectomy sensation, autologous breast reconstruction, DIEP flap
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nerve SutureProcedure or surgery
Sensory nerve coaptations will be performed
- either by suturing the donor to the recipient nerve immediately (1 coaptation)
- or by interposing an autograft originating from the zone of the flap to be discarded (2 coaptations). The anterior cutaneous branch (ACB) of the 3rd or 4th intercostal nerve (ICN) will be connected to the sensory branch of the 10th, 11th or 12th ICN of the flap.
| Study group | Role | What they receive |
|---|---|---|
| no nerve suture | No intervention | No nerve suture will be carried out. |
| direct nerve suture | Experimental | Epineural coaptation of one nerve of the flap to one nerve of the breast region Receives: Procedure: Nerve Suture |
| interposition of an autograft | Experimental | Epineural coaptation intercostal nerve flap to autograft (from another intercostal nerve of the flap) to intercostal nerve of the breast = interposition of an autograft Receives: Procedure: Nerve Suture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Semmes-Weinstein-Monofilament-Test
The results of one modality of the sensory testing, the Semmes-Weinstein-Monofilament-Test for pressure perception.
The breast will be divided into 9 zones, which will all be measured with the Semmes Weinstein monofilament 20-piece full kit (unit: grams of force) at the given time (see time frame).
Measured: At 12-months-follow-up
Secondary outcomes (16)
Change in breast sensation
Semmes-Weinstein monoflament The breast will be divided into 9 zones, which will all be measured with the Semmes Weinstein monofilament 20-piece full kit at the given times (see time frame).
The resulting monofilament values (unit: grams of force) are examined over the various specified periods and the delta is determined.
Measured: day-1/1week/3/6/12/24 months postop
Sensory recovery to DIEP flap
2-point-discrimination, i.e. threshold distance between two points that are perceived as separate in millimeters. Instrument: Aesthesiometer. 9 zones of the breast.
Measured: 12 months postop
Change in breast sensation
2-point-discrimination, i.e. threshold distance between two points that are perceived as separate in millimeters. Instrument: Aesthesiometer. 9 zones of the breast.
Measurement at the specified times (see time frame), determination of the delta.
Measured: day-1/1week/3/6/12/24 months postop
Sensory recovery to DIEP flap
Vibration perception with tuning forks of 256 and 32 Hz. Binary: yes/no on 9 zones of the breast.
Measured: 12 months postop
Change in breast sensation
Vibration perception with tuning forks of 256 and 32 Hz. 9 zones of the breast. Binary: yes/no Evaluation of the difference in the number of zones of the breast with perception of vibration, delta over different time points.
Measured: day-1/1week/3/6/12/24 months postop
Sensory recovery to DIEP flap
Temperature perception. Metal rods of 6°C and 37°C. Patients have to indicate which rod feels colder that the other. Capacity of differentiation of temperature: yes/no on 9 zones of the breast.
Measured: 12 months postop
Change in breast sensation
Temperature perception. Metal rods of 6°C and 37°C. Patients have to indicate which rod feels colder that the other. Capacity of differentiation of temperature: yes/no on 9 zones of the breast. Testing at given time points (see time frame), Calculation of delta of number of zones with distinction.
Measured: day-1/1week/3/6/12/24 months postop
Sensory recovery to DIEP flap
Temperature surface. FLIR thermal camera, flap monitor versus whole breast and contralateral breast surface temperature, difference in temperature in degree Celsius.
Measured: 12 months postop
Change in breast sensation
Temperature surface. FLIR thermal camera, flap monitor versus whole breast and contralateral breast surface temperature, difference in temperature in degree Celsius. Calculation of delta over given time points (see time frame)
Measured: day-1/1week/3/6/12/24 months postop
Sensory recovery to DIEP flap
Sharp/dull:
Instrument system used: 18G needle / cotton swab, on nine areas of the breast.
- Each area will be tested 3 consecutive times with both objects (i.e., 6 measurements per area)
- The distinction between prick and gentle pressure will be considered successful if the patient responds correctly 5 times out of 6 or 6 times out of 6 (distinction ability: yes/no)
Measured: 12 months postop
Change in breast sensation
Sharp/dull:
Instrument system used: 18G needle / cotton swab, on nine areas of the breast.
- Each area will be tested 3 consecutive times with both objects (i.e., 6 measurements per area)
- The distinction between prick and gentle pressure will be considered successful if the patient responds correctly 5 times out of 6 or 6 times out of 6 (distinction ability: yes/no) Delta calculation over given time points (see time frame)
Measured: day-1/1week/3/6/12/24 months postop
Breast-specific health-related QoL
Breast-Q®
Measured: 12 months postop
Breast-specific health-related QoL (change over time)
Breast-Q®, delta of points over time (see time frame)
Measured: Day -1, 12 &24 months postop
Operative time
Minutes for nerve coaptation(s)
Measured: At time of 1st operation
Changes to DIEP flap skin
Proteomics, neuroprotein quantification
Measured: A) Pilot study Postoperatively at any time of follow-up-interventions. B) Main study At time of 1st operation and at 6-months-follow-up
Sensory recovery to DIEP flap
2-point-discrimination, i.e. threshold distance between two points that are perceived as separate in millimeters. Instrument: Aesthesiometer.
Measured: 12 months postop
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2025
- Study startApr 2025 (estimated)
- Primary completionFeb 2028 (estimated)
- Study completionFeb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Breast Cancer SurgeryStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Three-arm, Randomised, Double-blinded Superiority Trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 63 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Patricia Esther Engels
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Patricia Esther Engels, University Hospital, Geneva
- Investigators
- Patricia E Engels, MD, Principal investigator, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06930378
- Sponsor's protocol ID
- SNCTP000006257
- Other IDs
- BASEC2024-02109
- Acronym
- S-DIEP
- Status last verified
- Apr 2025
- First submitted
- 3 Mar 2025
- Last updated
- 16 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Puonti HK, Broth TA, Soinila SO, Hallikainen HK, Jaaskelainen SK. How to Assess Sensory Recovery After Breast Reconstruction Surgery? Clin Breast Cancer. 2017 Oct;17(6):471-485. doi: 10.1016/j.clbc.2017.04.011. Epub 2017 Apr 29.
PubMed 28673764Blondeel PN, Demuynck M, Mete D, Monstrey SJ, Van Landuyt K, Matton G, Vanderstraeten GG. Sensory nerve repair in perforator flaps for autologous breast reconstruction: sensational or senseless? Br J Plast Surg. 1999 Jan;52(1):37-44. doi: 10.1054/bjps.1998.3011.
PubMed 10343589Spiegel AJ, Salazar-Reyes H, Izaddoost S, Khan FN. A novel method for neurotization of deep inferior epigastric perforator and superficial inferior epigastric artery flaps. Plast Reconstr Surg. 2009 Jan;123(1):29e-30e. doi: 10.1097/PRS.0b013e3181905564. No abstract available.
PubMed 19116520Bijkerk E, Beugels J, van Kuijk SMJ, Lataster A, van der Hulst RRWJ, Tuinder SMH. Clinical Relevance of Sensory Nerve Coaptation in DIEP Flap Breast Reconstruction Evaluated Using the BREAST-Q. Plast Reconstr Surg. 2022 Nov 1;150(5):959e-969e. doi: 10.1097/PRS.0000000000009617. Epub 2022 Aug 22.
PubMed 35993852Shiah E, Laikhter E, Comer CD, Manstein SM, Bustos VP, Bain PA, Lee BT, Lin SJ. Neurotization in Innervated Breast Reconstruction: A Systematic Review of Techniques and Outcomes. J Plast Reconstr Aesthet Surg. 2022 Sep;75(9):2890-2913. doi: 10.1016/j.bjps.2022.06.006. Epub 2022 Jun 17.
PubMed 35872020Ducic I, Yoon J, Momeni A, Ahcan U. Anatomical Considerations to Optimize Sensory Recovery in Breast Neurotization with Allograft. Plast Reconstr Surg Glob Open. 2018 Nov 7;6(11):e1985. doi: 10.1097/GOX.0000000000001985. eCollection 2018 Nov.
PubMed 30881792Spiegel AJ, Menn ZK, Eldor L, Kaufman Y, Dellon AL. Breast Reinnervation: DIEP Neurotization Using the Third Anterior Intercostal Nerve. Plast Reconstr Surg Glob Open. 2013 Dec 6;1(8):e72. doi: 10.1097/GOX.0000000000000008. eCollection 2013 Nov.
PubMed 25289267Beugels J, Cornelissen AJM, van Kuijk SMJ, Lataster A, Heuts EM, Piatkowski A, Spiegel AJ, van der Hulst RRWJ, Tuinder SMH. Sensory Recovery of the Breast following Innervated and Noninnervated DIEP Flap Breast Reconstruction. Plast Reconstr Surg. 2019 Aug;144(2):178e-188e. doi: 10.1097/PRS.0000000000005802.
PubMed 31348332Hamilton KL, Kania KE, Spiegel AJ. Post-mastectomy sensory recovery and restoration. Gland Surg. 2021 Jan;10(1):494-497. doi: 10.21037/gs.2020.03.22.
PubMed 33634007Bijkerk E, van Kuijk SMJ, Lataster A, van der Hulst RRWJ, Tuinder SMH. Breast sensibility in bilateral autologous breast reconstruction with unilateral sensory nerve coaptation. Breast Cancer Res Treat. 2020 Jun;181(3):599-610. doi: 10.1007/s10549-020-05645-y. Epub 2020 Apr 28.
PubMed 32346819
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensory Restoration in DIEP Free Flaps for Post-Mastectomy Breast Reconstruction After Breast Cancer: Comparing Non-sensitized Standard Technique to Direct Nerve Suture and to Autograft: A Three-arm, Randomized, Double-blinded Superiority Trial
- ClinicalTrials.gov ID
- NCT06930378
- Acronym / sponsor ID
- S-DIEP / SNCTP000006257
- Conditions
- Breast Cancer Surgery, Reconstruction Breast Surgery, Sensitization, DIEP Flap Breast Reconstruction
- Keywords
- free flap, breast reconstruction, autologous-based reconstruction, neurotization, sensory recovery, post-mastectomy sensation, autologous breast reconstruction, DIEP flap
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 63 participants (estimated)
- Lead sponsor
- Patricia Esther EngelsUniversity, hospital or other
- Study start
- Apr 2025 (estimated)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Feb 2029 (estimated)
- First posted
- 16 Apr 2025 (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.
The goal of this clinical trial is to learn if nerve sutures in free flap breast reconstruction can optimize sensibility in the reconstructed breast in patients opting for DIEP flap breast reconstruction due to breast cancer or genetic conditions. Affected women 18 to 80 years old can be included. The main question is:
If a nerve suture was carried out, can pressure be felt better on the reconstructed breast after 12 months? If a nerve suture was carried out, will better sensibility and quality of life be felt and perceived (questionnaire) at 12 and 24 months after the initial operation ? Researchers will compare two different nerve suture techniques and no nerve suture to one another to see if and which nerve suture optimizes sensibility.
Participants will have regular visits and follow-up controls, during which
- their sensibility will be tested multimodally,
- they will fill out questionnaires
- skin biopsies will be taken.
Detailed description
Breast reconstruction with autologous tissue is one of the most important methods: The DIEP (deep inferior epigastric artery perforator) flap is today's workhorse in autologous reconstruction. Routinely, the arteries and veins of the donor- and recipient sites are connected, but not the nerves. The sensory recovery is an undervalued aspect despite the disadvantages of insensate flaps. Connection of the abdominal flap skin's nerves to the breast region's nerves allows sensitized reconstruction. The research project aims to make sensitized flap-based breast reconstruction the standard method by proving its superiority, using the sensory testing with Semmes-Weinstein-Monofilament (pressure threshold) as the primary outcome measured before surgery and 12 months post-surgery. Therefore, patients will be randomized in three groups:
- sensitization with direct nerve suture or
- autograft or
- no sensitization. Moreover, no previous studies have analyzed the potential changes in flap skin with proteomics, thus justifying our secondary objective.
The hypothesis is that flaps with nerve suture(s) have better sensibility. The main outcome will be the sensory testing (pressure threshold). As secondary outcomes the questionnaire will show the patients' quality of life, and the proteomic analysis, should, according to our hypothesis, show that quantity and expression of the proteins of flap skin with nerve suture are closer to normal skin than without nerve suture.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Three-arm, Randomised, Double-blinded Superiority Trial
| Arm | Type | Receives |
|---|---|---|
| no nerve suture | No intervention | –No nerve suture will be carried out. |
| direct nerve suture | Experimental | Procedure: Nerve SutureEpineural coaptation of one nerve of the flap to one nerve of the breast region |
| interposition of an autograft | Experimental | Procedure: Nerve SutureEpineural coaptation intercostal nerve flap to autograft (from another intercostal nerve of the flap) to intercostal nerve of the breast = interposition of an autograft |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18-80 years old
- having received DIEP flap breast reconstruction with a flap not completely buried
- having given written informed consent for participating in the study
- 18 to 80 years old
- having given written informed consent for participating in the study
Key exclusion criteria (13 listed)
- postoperative radiotherapy on the flap
- neurological conditions as diabetic neuropathy, alcoholism or any other severe underlying peripheral neuropathy including chemotherapy-induced neuropathy or neuropathy induced by other medications
- active smoking
- language barrier
- pregnancy or lactating women
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 |
|---|---|---|
| Nerve SutureSensory nerve coaptations will be performed 1. either by suturing the donor to the recipient nerve immediately (1 coaptation) 2. or by interposing an autograft originating from the zone of the flap to be discarded (2 coaptations). The anterior cutaneous branch (ACB) of the 3rd or 4th intercostal nerve (ICN) will be connected to the sensory branch of the 10th, 11th or 12th ICN of the flap. | Procedure or surgery | direct nerve suture, interposition of an autograft |
Primary outcome
Semmes-Weinstein-Monofilament-Test
Time frame: At 12-months-follow-up
The results of one modality of the sensory testing, the Semmes-Weinstein-Monofilament-Test for pressure perception. The breast will be divided into 9 zones, which will all be measured with the Semmes Weinstein monofilament 20-piece full kit (unit: grams of force) at the given time (see time frame).
16 secondary outcomes
Change in breast sensation
Time frame: day-1/1week/3/6/12/24 months postop
Sensory recovery to DIEP flap
Time frame: 12 months postop
Change in breast sensation
Time frame: day-1/1week/3/6/12/24 months postop
Sensory recovery to DIEP flap
Time frame: 12 months postop
Change in breast sensation
Time frame: day-1/1week/3/6/12/24 months postop
Sensory recovery to DIEP flap
Time frame: 12 months postop
Change in breast sensation
Time frame: day-1/1week/3/6/12/24 months postop
Sensory recovery to DIEP flap
Time frame: 12 months postop
Change in breast sensation
Time frame: day-1/1week/3/6/12/24 months postop
Sensory recovery to DIEP flap
Time frame: 12 months postop
Change in breast sensation
Time frame: day-1/1week/3/6/12/24 months postop
Breast-specific health-related QoL
Time frame: 12 months postop
Breast-specific health-related QoL (change over time)
Time frame: Day -1, 12 &24 months postop
Operative time
Time frame: At time of 1st operation
Changes to DIEP flap skin
Time frame: A) Pilot study Postoperatively at any time of follow-up-interventions. B) Main study At time of 1st operation and at 6-months-follow-up
Sensory recovery to DIEP flap
Time frame: 12 months postop
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2025.
- Background: PubMed 28673764Puonti HK, Broth TA, Soinila SO, Hallikainen HK, Jaaskelainen SK. How to Assess Sensory Recovery After Breast Reconstruction Surgery? Clin Breast Cancer. 2017 Oct;17(6):471-485. doi: 10.1016/j.clbc.2017.04.011. Epub 2017 Apr 29.
- Background: PubMed 10343589Blondeel PN, Demuynck M, Mete D, Monstrey SJ, Van Landuyt K, Matton G, Vanderstraeten GG. Sensory nerve repair in perforator flaps for autologous breast reconstruction: sensational or senseless? Br J Plast Surg. 1999 Jan;52(1):37-44. doi: 10.1054/bjps.1998.3011.
- Background: PubMed 19116520Spiegel AJ, Salazar-Reyes H, Izaddoost S, Khan FN. A novel method for neurotization of deep inferior epigastric perforator and superficial inferior epigastric artery flaps. Plast Reconstr Surg. 2009 Jan;123(1):29e-30e. doi: 10.1097/PRS.0b013e3181905564. No abstract available.
- Background: PubMed 35993852Bijkerk E, Beugels J, van Kuijk SMJ, Lataster A, van der Hulst RRWJ, Tuinder SMH. Clinical Relevance of Sensory Nerve Coaptation in DIEP Flap Breast Reconstruction Evaluated Using the BREAST-Q. Plast Reconstr Surg. 2022 Nov 1;150(5):959e-969e. doi: 10.1097/PRS.0000000000009617. Epub 2022 Aug 22.
- Background: PubMed 35872020Shiah E, Laikhter E, Comer CD, Manstein SM, Bustos VP, Bain PA, Lee BT, Lin SJ. Neurotization in Innervated Breast Reconstruction: A Systematic Review of Techniques and Outcomes. J Plast Reconstr Aesthet Surg. 2022 Sep;75(9):2890-2913. doi: 10.1016/j.bjps.2022.06.006. Epub 2022 Jun 17.
- Background: PubMed 30881792Ducic I, Yoon J, Momeni A, Ahcan U. Anatomical Considerations to Optimize Sensory Recovery in Breast Neurotization with Allograft. Plast Reconstr Surg Glob Open. 2018 Nov 7;6(11):e1985. doi: 10.1097/GOX.0000000000001985. eCollection 2018 Nov.
- Background: PubMed 25289267Spiegel AJ, Menn ZK, Eldor L, Kaufman Y, Dellon AL. Breast Reinnervation: DIEP Neurotization Using the Third Anterior Intercostal Nerve. Plast Reconstr Surg Glob Open. 2013 Dec 6;1(8):e72. doi: 10.1097/GOX.0000000000000008. eCollection 2013 Nov.
- Background: PubMed 31348332Beugels J, Cornelissen AJM, van Kuijk SMJ, Lataster A, Heuts EM, Piatkowski A, Spiegel AJ, van der Hulst RRWJ, Tuinder SMH. Sensory Recovery of the Breast following Innervated and Noninnervated DIEP Flap Breast Reconstruction. Plast Reconstr Surg. 2019 Aug;144(2):178e-188e. doi: 10.1097/PRS.0000000000005802.
- Background: PubMed 33634007Hamilton KL, Kania KE, Spiegel AJ. Post-mastectomy sensory recovery and restoration. Gland Surg. 2021 Jan;10(1):494-497. doi: 10.21037/gs.2020.03.22.
- Background: PubMed 32346819Bijkerk E, van Kuijk SMJ, Lataster A, van der Hulst RRWJ, Tuinder SMH. Breast sensibility in bilateral autologous breast reconstruction with unilateral sensory nerve coaptation. Breast Cancer Res Treat. 2020 Jun;181(3):599-610. doi: 10.1007/s10549-020-05645-y. Epub 2020 Apr 28.
- Individual participant dataSharing planned: No
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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.
Patricia E Engels, MD principal investigator
University Hospital, Geneva
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nerve Suture in people with Breast Cancer Surgery and Reconstruction Breast Surgery, run by Patricia Esther Engels at 1 site in Switzerland.
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 6 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 16 Apr 2025. 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 Switzerland. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Patricia E Engels, MD (+41795537557, patricia.engels@hug.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Semmes-Weinstein-Monofilament-Test (time frame: At 12-months-follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06930378, which also lists 10 linked publications.
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 16 Apr 2025.