Background: Over the last years, less invasive surgical techniques with soft tissue preservation for bone conduction\nhearing implants (BCHI) have been introduced such as the linear incision technique combined with a punch. Results\nusing this technique seem favorable in terms of rate of peri-abutment dermatitis (PAD), esthetics, and preservation of skin\nsensibility. Recently, a new standardized surgical technique for BCHI placement, the Minimally Invasive Ponto Surgery\n(MIPS) technique has been developed by Oticon Medical AB (Askim, Sweden). This technique aims to standardize surgery\nby using a novel surgical instrumentation kit and minimize soft tissue trauma.\nMethods: A multicenter randomized controlled trial is designed to compare the MIPS technique to the linear incision\ntechnique with soft tissue preservation. The primary investigation center is Maastricht University Medical Center. Sixty-two\nparticipants will be included with a 2-year follow-up period. Parameters are introduced to quantify factors such as loss of\nskin sensibility, dehiscence of the skin next to the abutment, skin overgrowth, and cosmetic results. A new type of\nsampling method is incorporated to aid in the estimation of complications. To gain further understanding of PAD, swabs\nand skin biopsies are collected during follow-up visits for evaluation of the bacterial profile and inflammatory cytokine\nexpression.\nThe primary objective of the study is to compare the incidence of PAD during the first 3 months after BCHI placement.\nSecondary objectives include the assessment of parameters related to surgery, wound healing, pain, loss of sensibility of\nthe skin around the implant, implant extrusion rate, implant stability measurements, dehiscence of the skin next to the\nabutment, and esthetic appeal. Tertiary objectives include assessment of other factors related to PAD and a health\neconomic evaluation.\nDiscussion: This is the first trial to compare the recently developed MIPS technique to the linear incision technique with\nsoft tissue preservation for BCHI surgery. Newly introduced parameters and sampling method will aid in the prediction of\nresults and complications after BCHI placement.
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