Clin2
NCT05945329Possibly a fitRecruiting

New scar-wrap to treat painful tightness after breast implants

Capsular Contracture Associated With Breast ImplantCapsular Contracture Grade IIICapsular Contracture Grade IV

Part of Cancer, Skin clinical trials.

This trial tests a medical mesh/scaffold (GalaFLEX LITE™) used during revision surgery to help treat capsular contracture, where scar tissue tightens around a breast implant. It may improve comfort and the appearance of the breast after implant augmentation problems.

Summary written for real people, not researchers, by Clin2.

Phase
N/A
Enrollment
250 people
Ages
22 years to 70 years
Study type
Interventional

Who can take part

  • You were assigned female at birth, and you’re between 22 and 70 years old
  • You have capsular contracture with Baker grade 3 or 4 (the tightness is considered severe)
  • You want new silicone implants with no more than about a 150cc change in size
  • You plan to have the revision done through an incision under the breast fold (IMF)
  • You can come to study visits for 2 years and use an electronic diary with smart technology
  • You’re able to sign informed consent after reviewing the implant decision checklist

View the official record on ClinicalTrials.gov

Quick eligibility check

Answer a few plain-language questions, based on this study's own requirements, to get a preliminary sense of fit.

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