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

NCT06930378 | Recruiting DMC

• 2 other identifiers: SNCTP000006257BASEC2024-02109
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief 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. 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.

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

Outcome Measures

Primary Outcomes (1)

• 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).

  At 12-months-follow-up

Secondary Outcomes (16)

• Change in breast sensation

  day-1/1week/3/6/12/24 months postop

• Sensory recovery to DIEP flap

  12 months postop

• Change in breast sensation

  day-1/1week/3/6/12/24 months postop

• Sensory recovery to DIEP flap

  12 months postop

• Change in breast sensation

  day-1/1week/3/6/12/24 months postop

Study Arms (3)

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

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

Procedure: Nerve Suture

Interventions

Nerve Suture PROCEDURE

Sensory 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.

direct nerve suture; interposition of an autograft

Eligibility Criteria

• Age: 18 Years - 80 Years
• Gender Eligibility Details: XX chromosome patients willing to have autologous breast reconstruction
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old
• having received DIEP flap breast reconstruction with a flap not completely buried
• having given written informed consent for participating in the study

You may not qualify if:

• 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
• 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
• 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

Sponsors & Collaborators

• Patricia Esther Engels: lead

Study Sites (1)

Geneva University Hospitals

Geneva, Canton of Geneva, 1205, Switzerland

RECRUITING

Related Publications (10)

• 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.

  PMID: 28673764 BACKGROUND

• Blondeel 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.

  PMID: 10343589 BACKGROUND

• Spiegel 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.

  PMID: 19116520 BACKGROUND

• Bijkerk 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.

  PMID: 35993852 BACKGROUND

• Shiah 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.

  PMID: 35872020 BACKGROUND

• Ducic 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.

  PMID: 30881792 BACKGROUND

• Spiegel 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.

  PMID: 25289267 BACKGROUND

• Beugels 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.

  PMID: 31348332 BACKGROUND

• Hamilton 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.

  PMID: 33634007 BACKGROUND

• Bijkerk 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.

  PMID: 32346819 BACKGROUND

Study Officials

• Patricia E Engels, MD

  University Hospital, Geneva

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patricia E Engels, MD

CONTACT

+41795537557; patricia.engels@hug.ch

Axelle Serre, MD

CONTACT

+41795538642; axelle.serre@usb.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator, Consultant and Senior Clinical Researcher

Model Details: Three-arm, Randomised, Double-blinded Superiority Trial

Study Record Dates

• First Submitted: March 3, 2025
• First Posted: April 16, 2025
• Study Start: April 1, 2025
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2029
• Last Updated: April 16, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)