Acellular dermal matrix has enhanced implant-based reconstruction and remains useful in immediate prosthetic breast reconstruction. It is associated, however, with higher rates of postoperative seroma and infection. Careful patient selection, choice of tissue expander/implant volume, and postoperative management are warranted to optimize overall reconstructive outcome.
Although implant-based breast reconstruction using ADM has been associated with increased seroma and possible infection rates, the use of specific clinical practices designed to prevent seroma has minimized our rate of these postoperative complications.
Decreased inflammatory response seen in wet wound healing may be correlated with diminished scarring. This study seeks to test this hypothesis and to validate a model of scarring in the Yorkshire pig. Four Yorkshire pigs were used to create 36 dorsal wounds per pig (144 wounds total) in the following groups: full-thickness excisional, partial thickness, meshed split-thickness skin grafts, sheet split-thickness skin grafts, minced skin, and incisional wounds. Wounds were randomized into wet and dry groups. Wet wounds were enclosed in polyurethane chambers with 2 mL of normal saline. Dry wounds were covered with regular gauze. Terminal biopsies were performed at 72 hours and day 28. Histology demonstrated significantly less inflammatory infiltrate, thicker neoepidermis, more pronounced rete ridge formation, and decreased scar tissue thickness in wet wounds. The mean macroscopic scar surface area was significantly decreased in full-thickness excisional wet wounds compared with dry wounds (61.2 mm(2) vs. 150.8 mm(2), p<0.01). Hydroxyproline content was decreased in full-thickness wet compared with dry groups (44.81 vs. 62.21 mg/g, p<0.01). Tensile strength was 90% greater in full-thickness wet compared with dry groups (p<0.01). Healing in the liquid environment significantly reduced scar formation. This model will allow for future investigation of high-concentration topical scar-modulating agents in the liquid environment.
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This article illustrates the importance of Good Clinical Practice (GCP), defines and outlines the goals of GCP, presents a historical perspective on GCP and Outlines FDA regulations relating to GCP. Ongoing research shows that whether conducting research involving a new drug, a behavioral intervention, or an interview/survey, Good Clinical Practice (GCP) provides investigators and their study teams with the tools to protect human subjects and collect quality data. In this article, the author will define GCP, explain the benefits of following GCP for all types of human research and clinical trial studies, and provide some resources to assist investigators in implementing the tenets of GCP for their own research studies. This article reviews the impact of Good Clinical Practice (GCP) on clinical trials. GCP is likely to follow the International Conference on Harmonization of GCP guidelines in many aspects. GCP will enforce tighter guidelines on ethical aspects of a clinical study. Higher standards will be required in terms of comprehensive documentation for the clinical protocol, record keeping, training, and facilities including computers. Quality assurance and inspections will ensure that these standards are achieved. The additional requirements of GCP are discussed and any advantage to the study subject. GCP aims to ensure that the studies are scientifically authentic and that the clinical properties of the investigational product are properly documented. In this paper, we address the background history and the events that led up to the formation of these guidelines. Today, the GCP are used in clinical trials throughout the globe with the main aim of protecting and preserving human rights.
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