Evaluation of Cutaneous Sensory Function and Subcutaneous Tissue Changes Following Skin-Sparing Mastectomy: A Prospective, Controlled Clinical Study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00037908

Enrollment

125

Registered

2025-09-15

Start date

2026-01-01

Completion date

Unknown

Last updated

2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

R20 C50 Z87 G90 G57 T81 T87 Z98

Interventions

Group 1: Study arm: Prospective cohort study – patients after skin-sparing mastectomy Description of intervention/exposure: Patients undergoing skin-sparing mastectomy (SSM) with immediate breast reco

Eligibility

Sex/Gender

Female

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: • Women between the ages of 18 and 75 • Planned unilateral or bilateral SSM • Planned immediate reconstruction • No previous breast/thoracic wall surgery • Capacity to give consent

Exclusion criteria

Exclusion criteria: • Pre-existing peripheral neuropathy/neurodegenerative diseases • Poorly controlled diabetes mellitus/diabetic neuropathy • Previous radiation therapy to the chest/thoracic wall • Use of neurotoxic medications

Design outcomes

Primary

Measure	Time frame
Change in cutaneous sensory function in the preserved skin envelope after skin-sparing mastectomy over a period of 12 months, measured by: Quantitative sensory testing (QST): Change in thresholds for thermal sensation (warm and cold sensation) and mechanical detection from preoperative to 12 months postoperative Clinical sensitivity mapping: Change in touch and pain sensation using standardized tests (monofilaments, sharp/dull discrimination) in defined breast regions Measurement times: Preoperatively (baseline) and 12 months postoperatively	—

Measure

Time frame

Change in cutaneous sensory function in the preserved skin envelope after skin-sparing mastectomy over a period of 12 months, measured by: Quantitative sensory testing (QST): Change in thresholds for thermal sensation (warm and cold sensation) and mechanical detection from preoperative to 12 months postoperative Clinical sensitivity mapping: Change in touch and pain sensation using standardized tests (monofilaments, sharp/dull discrimination) in defined breast regions Measurement times: Preoperatively (baseline) and 12 months postoperatively

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Secondary

Measure	Time frame
Comparison of sensory recovery between different reconstruction techniques: Differences in sensory thresholds between different surgical approaches and reconstruction methods Identification of predictors of sensory recovery: Influence of age, BMI, nerve preservation, and surgical details on sensory recovery Correlation between subcutaneous fat thickness and sensory function Correlation of objective sensitivity measurements with patient-reported outcomes: Relationship between QST results and BREAST-Q scores Correlation with VAS scale for numbness and quality of life indices (SF-36/EQ-5D) Quantification of subcutaneous tissue changes: Change in subcutaneous fat thickness using high-resolution ultrasound (preoperative vs. postoperative) Assessment of fibrosis and tissue elasticity Influence of axillary surgery on sensory outcomes: Comparison of sensory recovery between ALND vs. SNB Influence of the surgical approach (intracavitary vs. separate incision) on postoperative sensitivity Exploratory endpoint: Correlation between subcutaneous tissue preservation and sensory recovery for the development of nerve-sparing surgical strategies All secondary endpoints will be assessed at the defined follow-up times (14-28 days, 6 months, optionally 12 months).	—

Measure

Time frame

Comparison of sensory recovery between different reconstruction techniques: Differences in sensory thresholds between different surgical approaches and reconstruction methods Identification of predictors of sensory recovery: Influence of age, BMI, nerve preservation, and surgical details on sensory recovery Correlation between subcutaneous fat thickness and sensory function Correlation of objective sensitivity measurements with patient-reported outcomes: Relationship between QST results and BREAST-Q scores Correlation with VAS scale for numbness and quality of life indices (SF-36/EQ-5D) Quantification of subcutaneous tissue changes: Change in subcutaneous fat thickness using high-resolution ultrasound (preoperative vs. postoperative) Assessment of fibrosis and tissue elasticity Influence of axillary surgery on sensory outcomes: Comparison of sensory recovery between ALND vs. SNB Influence of the surgical approach (intracavitary vs. separate incision) on postoperative sensitivity Exploratory endpoint: Correlation between subcutaneous tissue preservation and sensory recovery for the development of nerve-sparing surgical strategies All secondary endpoints will be assessed at the defined follow-up times (14-28 days, 6 months, optionally 12 months).

—

Countries

Germany

Contacts

Public ContactMarion Tina van Mackelenbergh

Klinik für Gynäkologie und Geburtshilfe, Universitätsklinikum Schleswig-Holstein, Campus Kiel

mariontina.vanmackelenbergh@uksh.de+4943150021401

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Jun 11, 2026