Acellular dermal (alloderm) grafts versus silastic sheets implants for management of empty nose syndrome.

The objective of the study is to conduct a prospective randomized blind clinical study comparing the efficacy and safety of use of acellular dermal (alloderm) grafts versus silastic sheets submucosal implants for management of empty nose syndrome (ENS). A total of 24 patients with a clinical diagnosis of ENS were randomly distributed in two equal groups: silastic implant group and alloderm implant group according to the type of implant used to rebuild the nose. This implant was inserted in submucoperichondrial and/or submucoperiosteal pockets fashioned along the septum, nasal floor, and lateral nasal wall. Subjective evaluation was done by reviewing the Sino-Nasal Outcome Test (SNOT-25), while objective evaluation was done by anterior rhinoscopy and nasal endoscopy. Both groups experienced a significant improvement after surgery (the mean SNOT-25 score before implantation was 61.4 compared to 33.6 after implantation in silastic implant group, while in alloderm implant group, it was 63.7 before surgery compared to 34.2 after implantation). There was no statistical evidence for a significant difference between the two groups. Objective evaluation showed rapid healing with no signs of implant infection, rejection, or allergic reaction in both groups. Both graft materials are well suited to this procedure with no statistical evidence for a significant difference between them. The silastic implant is inert and yet incorporated into the surrounding tissue because of the fashioned macropores. It is available and inexpensive. Acellular dermis graft is reliable, predictable, and readily shaped. Patients of both groups showed marked subjective and objective improvements. The surgical procedure is safe and relatively simple to perform.

RCT Entities:   Population Interventions Outcomes