Experimental and Clinical Investigation of the Implant Surface Roughness Reduction Effect on Early-stage Fibrosis

Conditions: Capsular Contracture Associated With Implant, Foreign-Body Reaction, Wounds and Injuries, Tissue Expander Disorder

Summary

The goal of this single-center, randomised double-blinded trial is to compare the early stage fibrosis progression around conventional textured expander and the SmoothSilk® expander with reduced surface roughness in women undergoing bilateral nipple or skin sparing mastectomy in a prophylactic setting followed by tissue-expander based breast reconstruction. Researchers will compare intra-individually, the conventional textured expander CPX®(Mentor) and the SmoothSilk® (Motiva) expander (i) to gain a comprehensive insight into immunological mechanisms occurring at the timepoint of expander insertion (within the first days after implantation) based on WBF analysis in vitro, (ii)to determine the role and function of immune cells in a rather early stage of capsule formation (6-8 months after implantation) and under well-defined conditions in humans as well as (iii)to analyze the aesthetic outcome and clinical parameters after bilateral implant-based reconstruction using two expanders with varying surface topography within the individual patient (intra-individually).

Eligibility Criteria

Inclusion Criteria:Age > 18 yearsFemale sexHigh risk family history for mammary and/or ovarian cancerPlanned prophylactic mastectomy with simultaneous breast reconstructionSigned informed consent formExclusion Criteria:Confirmed sever Coagulation disorder, representing a potential contraindication for the elective surgeryConfirmed Rheumatic disease accompanied by obligatory intake of immunomodulating therapeutic agentsConfirmed severe renal functional disorder: Renal insufficiency status IV or VActive hematological or oncological diseaseHIV-InfectionHepatitis-InfectionPregnancy or breast feedingIntake of anti-inflammatory drugsCarrier of silicone implants (e.g. gastric banding, mammary implants)Subject is currently participating or intends to participate in another clinical trial that may interfere with the protocol of this studyPatients who have implanted devices that could be affected by a magnetic field (e.g., pacemakers, drug infusion devices, artificial sensing devices) * patients with removable devices such as removable diabetes pumps, sensors and transmitter might still part take,Patients with alteration in hematologic and serum protein reference values post-chemotherapy.When there is a residual malignancy in the intended expansion site.Existing tissue at the intended expansion site is not adequate according to the surgeon's criteria, because of previous radiation therapy, ulcerations, vascular compromise, history of compromised wound healing, or scar deformity.Radiation therapy before or after the expander placement can be associated with a higher rate of complications during the expansion and final implantation phases of the reconstructive process.Abscess or infection in the body in general.Participants with autoimmune diseases (e.g., lupus, scleroderma) or whose immune system is compromised (e.g., currently receiving immunosuppressive therapy such as steroids).Unsuitable tissue due to radiation damage on the chest wall, tight thoracic skin grafts or radical resection of the pectoralis major muscle.

Source: ClinicalTrials.gov (NCT05648929). StuddyBuddy aggregates publicly available trial information.