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NCT Number: NCT06930378

Improvement in Breast Skin Sensibility After Breast Reconstruction: a Comparison of 3 Surgical Techniques

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.

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Key information

Conditions

Breast Cancer Surgery DIEP Flap Breast Reconstruction Reconstruction Breast Surgery Sensitization

Age range

18 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Geneva University Hospitals

Geneva, Canton of Geneva, 1205, Switzerland

Location status: Recruiting

Location contact

Axelle Serre, MD

CONTACT

[email protected]

+41795538642

Axelle Serre, MD

SUB_INVESTIGATOR

Daniel F Kalbermatten, PhD

SUB_INVESTIGATOR

Patricia E Engels, MD

CONTACT

[email protected]

+41795537557

Patricia E Engels, MD

PRINCIPAL_INVESTIGATOR

Srinivas Madduri, PhD

SUB_INVESTIGATOR

Stephanie N Schulz, MD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

A) Pilot study

Inclusion criteria

  • 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

Exclusion criteria

  • 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

B) Main study

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Nerve Suture

Procedure

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.

Primary outcomes

  1. 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).

Secondary outcomes

  1. Change in breast sensation

    Time frame: day-1/1week/3/6/12/24 months postop

    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.

  2. Sensory recovery to DIEP flap

    Time frame: 12 months postop

    2-point-discrimination, i.e. threshold distance between two points that are perceived as separate in millimeters. Instrument: Aesthesiometer. 9 zones of the breast.

  3. Change in breast sensation

    Time frame: day-1/1week/3/6/12/24 months postop

    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.

  4. Sensory recovery to DIEP flap

    Time frame: 12 months postop

    Vibration perception with tuning forks of 256 and 32 Hz. Binary: yes/no on 9 zones of the breast.

  5. Change in breast sensation

    Time frame: day-1/1week/3/6/12/24 months postop

    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.

  6. Sensory recovery to DIEP flap

    Time frame: 12 months postop

    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.

  7. Change in breast sensation

    Time frame: day-1/1week/3/6/12/24 months postop

    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.

  8. Sensory recovery to DIEP flap

    Time frame: 12 months postop

    Temperature surface. FLIR thermal camera, flap monitor versus whole breast and contralateral breast surface temperature, difference in temperature in degree Celsius.

  9. Change in breast sensation

    Time frame: day-1/1week/3/6/12/24 months postop

    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)

  10. Sensory recovery to DIEP flap

    Time frame: 12 months postop

    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)

  11. Change in breast sensation

    Time frame: day-1/1week/3/6/12/24 months postop

    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)

  12. Breast-specific health-related QoL

    Time frame: 12 months postop

    Breast-Q®

  13. Breast-specific health-related QoL (change over time)

    Time frame: Day -1, 12 &24 months postop

    Breast-Q®, delta of points over time (see time frame)

  14. Operative time

    Time frame: At time of 1st operation

    Minutes for nerve coaptation(s)

  15. 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

    Proteomics, neuroprotein quantification

  16. Sensory recovery to DIEP flap

    Time frame: 12 months postop

    2-point-discrimination, i.e. threshold distance between two points that are perceived as separate in millimeters. Instrument: Aesthesiometer.

Study contacts

Contact information is provided by the study sponsor or research team.

Axelle Serre, MD

CONTACT

[email protected]

+41795538642

Patricia E Engels, MD

CONTACT

[email protected]

+41795537557

Sponsors and collaborators

Lead sponsor

Patricia Esther Engels

Other

Registry information

Official study 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

Acronym: S-DIEP

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
Apr 16, 2025
Registry last updated
Apr 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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