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Prospective Study of Sensation and Satisfaction in Cancer and Transgender Mastectomy Patients

NCT06094257 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 400

Last updated 2025-08-27

No results posted yet for this study

Summary

During breast surgery, sensory nerves are cut which may lead to reduced sensation and pain. Surgical reinnervation techniques have been developed with the aim of improving postoperative sensation by preserving the nerves and connecting them to the nipple and areola. The investigators aim to compare postoperative sensation and patient reported outcomes in patients undergoing reinnervation versus those not undergoing reinnervation to determine if there is a difference. The investigators will investigate this in patients undergoing gender-affirming mastectomy, implant-based breast reconstruction and autologous breast reconstruction. The investigators will use various tools that measure sensation quantitatively.

Conditions

  • Sensation Disorders
  • Sensation, Phantom
  • Pain, Postoperative
  • Pain, Chronic
  • Numbness
  • Sensory Disorder
  • Sensory Defect
  • Phantom Pain
  • Phantom Sensation

Interventions

DIAGNOSTIC_TEST

Sensory testing

Quantitative sensory testing (QST) will be performed. QST was developed to standardize the noninvasive assessment of the somatosensory nervous system and quantify functioning of all aspects of sensation (light touch, pressure, warm, cold, pain, vibration): 1. Thermal detection (Medoc TSA system): Cold detection threshold B) Warm detection threshold C) Heat pain threshold 2. Mechanical detection threshold (MRC Opti Hair von Frey Filaments) 3. Two-point discrimination (MRC Opti Hair von Frey Filaments) 4. Mechanical pain threshold (MRC Pinprick Stimulator) 5. Pressure pain threshold (Medoc Pressure algometer) 6. Tinel sign on physical exam 7. Vibration (tuning fork)

Sponsors & Collaborators

  • Massachusetts General Hospital

    collaborator OTHER

  • Weill Medical College of Cornell University

    lead OTHER

Principal Investigators

  • Lisa Gfrerer, MD, PhD · Weill Medical College of Cornell University

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-02-09
Primary Completion
2033-03-31
Completion
2033-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06094257 on ClinicalTrials.gov