NCT07185334|Active Not RecruitingDMC
Single-Stage Prepectoral Placement of Textured Implants Using a Polyester Mesh Endoprostheses With Fluoropolymer Coating in Patients With Breast Cancer
FluoropolyMesh
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FluoropolyMesh
Sponsor study identifier
interventional
100
1 country
1
Study Start
May 15, 2025
Actual (reported)Primary Completion
May 15, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
May 15, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
This study aims to evaluate the efficacy of using a polyester mesh endoprosthesis with a fluoropolymer coating in reducing postoperative complications, particularly protrusions, following subcutaneous mastectomy with simultaneous prepectoral placement of textured breast implants in women with breast cancer
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 15, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 15, 2025
Actual (reported)September 2, 2025
Actual (reported)September 22, 2025
Actual (reported)May 15, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
May 15, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Frequency of protrusions throughout the year
Implant protrusion is a complication that occurs after reconstructive plastic surgery. In this type of surgery, the implant is displaced from its anatomically correct position leading to its protrusion through the skin. This happens when the integrity or strength of the tissues that hold the implant (such as capsules, muscles, and fascia) is compromised.
1 year
1. Frequency of seroma 2. Frequency of Rippling 3. Frequency of Capsular contracture 4. Frequency of Dystopia
1 year
The main group will consist of patients with the planned volume of surgical intervention: subcutaneous mastectomy using a polyester mesh endoprosthesis with a fluoropolymer coating and simultaneous prepectoral placement of textured implants.
The control group will consist of patients who undergo surgical treatment for subcutaneous mastectomy, with simultaneous placement of textured breast implants with no polyester mesh endoprosthesis with a fluoropolymer coating
For this group of patients, the planned volume of surgical intervention is: subcutaneous mastectomy using a polyester mesh endoprosthesis with a fluoropolymer coating and one-stage prepectoral installation of textured implants.
This group of patients will undergo surgical intervention in deep subcutaneous mastectomy with simultaneous prepectoral placement of textured implants.
Saint Petersburg State University
Saint Petersburg, Russia
First Submitted
September 2, 2025
First Posted
September 22, 2025
Study Start
May 15, 2025
Actual (reported)Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
May 15, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
May 15, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
September 22, 2025
Record last verified: 2025-09
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