Collagen implantation in patients treated previously with silicone.
This multicentric, open study evaluated the efficacy and safety of Zyderm Collagen Implant (ZCI) in 158 patients with contour deficiencies of the dermis and a history of silicone fluid therapy. Following test implantation with ZCI, thirty-seven patients dropped out, including four patients who exhibited untoward responses to the implant material. Hence, 121 patients completed the course of therapy and were available for efficacy and safety evaluation. At 2-week intervals. ZCI was implanted intradermally in 327 sites; 186 (57%) were the identical sites that had been injected previously with silicone fluid. In 89% of patients, five injections or less of ZCI produced favourable clinical results. Moreover, of 176 sites injected five times or less, a consistent pattern of progressive improvement was observed with each additional injection, regardless of the aetiology of dermal lesions. Furthermore, no undesirable textural or pigmentary changes were apparent at any of the 327 treatment sites. An adverse effect consisting of localized swelling, induration and erythema at implantation sites occurred in one patient, but resolved spontaneously.
D000328:Adult; D000368:Aged; D002986:Clinical Trials as Topic; D003094:Collagen / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004547:Elastic Tissue / Q000187:drug effects; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D019736:Prostheses and Implants; D012826:Silicone Elastomers / Q000009:adverse effects*
D012826:Silicone Elastomers; D003094:Collagen