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

Launched by MEDICAL UNIVERSITY INNSBRUCK · Dec 5, 2022

Keywords

ClinConnect Summary

Expander Immunology trial is a single-center, randomized double-blinded trial. A total of 14 patients, undergoing prophylactic bilateral simultaneous NSME (nipple sparing mastectomy) and implant based breast reconstruction, will receive either SmoothSilk® (Motiva Flora) or other routinely used expander (Mentor CPX™4), randomised to left or right breast after mastectomy. Patient and laboratory expert will be double-blinded. Clinical follow-up visits will be scheduled at 2, 4, 5, 6, 7, 8 and 16 weeks post procedure. Biological sample collection of wound bed fluid will take place daily from da...

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Age \> 18 years
• • Female sex
• • High risk family history for mammary and/or ovarian cancer
• • Planned prophylactic mastectomy with simultaneous breast reconstruction
• • Signed informed consent form
• Exclusion Criteria:
• • Confirmed sever Coagulation disorder, representing a potential contraindication for the elective surgery
• • Confirmed Rheumatic disease accompanied by obligatory intake of immunomodulating therapeutic agents
• • Confirmed severe renal functional disorder: Renal insufficiency status IV or V
• • Active hematological or oncological disease
• • HIV-Infection
• • Hepatitis-Infection
• • Pregnancy or breast feeding
• • Intake of anti-inflammatory drugs
• • Carrier 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 study
• • Patients 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.

Trial Officials