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Deputy Director, University of Chicago Pritzker School of Medicine
Twenty-two patients had been treated with AlloDerm, and 12 had been treated with split-thickness skin grafts. The location of the grafts (AlloDerm vs autograft) were on the tongue (54% vs 25%), floor of mouth (9% vs 50%), tongue and floor of mouth (23% vs 8%), buccal (9% vs 0%), or other (5% vs 17%). More patients in the AlloDerm group were treated with radiotherapy (45% vs 17%), and the graft failure rate was higher (14% vs 0%). Histology on a subset of the patients showed increased inflammation, fibrosis, and elastic fibers with split-thickness skin grafts. Interpretation of these results is limited by the differences between the groups at baseline. Laryngoplasty There are several reports with short-term follow-up of micronized AlloDerm (Cymetra) injection for laryngoplasty. Original Review Date: Dec 2007 Current Review: Jan 2016 Next Review: Jan 2017 10 Bio-Engineered Skin and Soft Tissue Substitutes (3. In 5 patients (25%), the effect was temporary, and in 8 patients (40%) who had follow-up of 1 year or longer, the improvement was maintained. Longer-term study in a larger number of patients is needed to determine the durability of this procedure and to evaluate the safety of repeat injections. Tympanoplasty Vos et al reported a retrospective nonrandomized comparison of AlloDerm versus native tissue grafts for type I tympanoplasty in 2005. Operative time was reduced in the AlloDerm group (82 minutes for AlloDerm, 114 minutes for fascial cases, 140 minutes for fascia plus cartilage). There was no significant difference in the success rate of the graft (88% for AlloDerm, 89% for fascia grafts, 96. There was no significant difference in hearing between the groups at follow-up (time not specified). Longer-term controlled study in a larger number of patients is needed to determine the durability of this procedure. Diabetic Lower-Extremity Ulcers Apligraf In 2001, Veves et al reported on a randomized prospective study on the effectiveness of Apligraf (previously called Graftskin), a living skin equivalent, in treating noninfected nonischemic chronic plantar diabetic foot ulcers. Apligraf was applied at the beginning of the study and weekly thereafter for a maximum of 4 weeks (maximum of 5 applications) or earlier if complete healing occurred. At the 12-week follow-up visit, 63 (56%) Apligraf -treated patients achieved complete wound healing compared with 36 (38%) in the control group (p=0. The Kaplan-Meier method median time to complete closure was 65 days for Apligraf, significantly lower than the 90 days observed in the control group (p=0. The rate of adverse reactions was similar between the 2 groups with the exception of osteomyelitis and lower-limb amputations, both of which were less frequent in the Apligraf group. Pooling of data was performed because of the similarity and consistency of the 2 studies. Original Review Date: Dec 2007 Current Review: Jan 2016 Next Review: Jan 2017 11 Bio-Engineered Skin and Soft Tissue Substitutes longer in the European study (21 months vs 10 months in the U. Efficacy measures demonstrated superiority of Apligraf treatment over control-treated groups in both studies. In 2010, Kirsner et al reported on analysis of 2517 patients with diabetic neuropathic foot ulcers who were treated between 2001 and 2004. In this study, advanced biological therapy was used, on average, within 28 days from the first wound clinic visit and was associated with a median time to healing of 100 days. Wounds treated with engineered skin (Apligraf) as the first advanced biological therapy were 31. Wound size, wound grade, duration of wound, and time to initiation of advanced biological therapy affected the time to healing. All patients received pressure-reducing footwear and were encouraged to stay off their study foot as much as possible. At 12 weeks, the median percent wound closure for the Dermagraft group was 91% compared with 78% for the control group. Ulcers treated with Dermagraft closed significantly faster than ulcers treated with conventional therapy. Together, there was a lower rate of infection, cellulitis, and osteomyelitis in the Dermagraft-treated group (19% vs 32.
Therefore, the loss of these subjects did not significantly alter the evaluation of device safety or effectiveness. The pivotal clinical study included 35 Principal Investigators and 80 Sub-Investigators at sites that randomized subjects. The information provided does not raise any questions about the reliability of the data. Integra Wound Matrix Dressing (which contains the same dermal layer, but not the silicone layer of Integra Template), was cleared on September 10, 2002 for the same indications as the Integra Bilayer Matrix Wound Dressing. The submitted data provided a reasonable assurance that the device is effective for the treatment of partial and full-thickness neuropathic diabetic foot ulcers that are greater than six weeks in duration, with no capsule, tendon or bone exposed, when used in conjunction with standard diabetic ulcer care. The specific conclusions are: the study met the pre-specified primary effectiveness criterion of complete study ulcer closure, (as assessed by the investigator during the 16-week treatment period). Specifically, Integra Template was statistically superior in the: 1) percentage of subjects with complete study ulcer closure, as assessed by computerized planimetry. No significant differences between treatment groups were observed for General Health, Social Functioning, Role Emotional, Mental Health or Vitality Modules of this questionnaire. Review of baseline demographics and wound conditions, indicated that the two cohorts were well balanced. With the exception of baseline ulcer size and baseline ulcer age, no other study covariate. This observation is consistent with previous clinical studies of diabetic neuropathic foot ulcers. The submitted data provided a reasonable assurance that the device is safe for the treatment of partial and fullthickness neuropathic diabetic foot ulcers that are greater than six weeks in duration, with no capsule, tendon or bone exposed, when used in conjunction with standard diabetic ulcer care. The specific conclusions are: Safety assessments included clinical visits during the two week Pre-Treatment Phase, weekly assessments during the 16 week Treatment Phase, and monthly assessments during the three month Follow-up Phase. Serum chemistry parameters were also determined at baseline and the end of the Treatment Phase. Four Control subjects died during the study of causes unrelated to study treatment. Recognizing the limitations associated with reviewing safety information in the Integra LifeSciences Corporation Postmarketing Safety database, it appears that the types and incidence of adverse events observed with Integra (and similar products) are reported at a low level and do not raise any concerns for the proposed indication for use. Since the product has been on the market in various forms since 1996, it is also unlikely that further post market experience will provide different information as to safety of the device. Furthermore, there is no reason to expect that "real-world" experience will differ. Thus, the safety profile of Integra Template in seriously burned patients for the past 19 years was an important consideration. If wound closure can be achieved, it is likely to delay the need for surgical intervention and offer other benefits such as improvements in: productivity, mental outlook, social interactions, and time at work, as well as decreased mortality. The benefits of Omnigraft observed in this study were improved ulcer healing rates and patient condition. The risks associated with this product are well known and no new or unexpected risks were identified during the trial in this population. The safety and efficacy of this product in this population was superior to standard of care. Overall Conclusion the data in this application support the reasonable assurance of safety and effectiveness of this device when used in accordance with the indications for use. Hazard to Health from Use of the Device: See Indications, Contraindications, Warnings, and Precautions, Adverse Reactions in the device labeling. The dermal replacement layer consists of a porous, three-dimensional matrix, comprised of bovine collagen and chondtroitin-6-sulfate (C6S) that is designed with a controlled porosity and defined degradation rate. Omnigraft, also marketed as Integra Dermal Regeneration Template, is provided sterile and non-pyrogenic. Integra Dermal Regeneration Template is indicated for: the postexcisional treatment of life-threatening full-thickness or deep partial-thickness thermal injuries where sufficient autograft is not available at the time of excision or not desirable due to the physiological condition of the patient; repair of scar contractures when other therapies have failed or when donor sites for repair are not sufficient or desirable due to the physiological condition of the patient; and treatment of partial and full-thickness neuropathic diabetic foot ulcers that are greater than six weeks in duration with no capsule, tendon or bone exposed, when used in conjunction with standard diabetic ulcer care. Such use should occur only when the anticipated benefit clearly outweighs the risk.
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The pulse and blood pressure should be checked regularly if there is a debilitating blow over the spleen, liver, or kidneys and the athlete should be kept fasting and refrain from taking medications or fluids by mouth. If the athlete collapses or has clinical peritonism, they should be placed in a recumbent position, with their legs elevated to assist venous return and arrangements made for immediate transfer to hospital. If the patient is standing and appears to be functioning adequately, it is advisable to take the patient off the FoP for a formal examination and particularly if the patient is dazed or unsteady. Assess the patient noting if the patient is conscious, able to speak, in pain, cyanotic, or dyspneic. If there is any possibility of a cervical spine injury, carefully maintain inline immobilization of the head and neck while performing the primary survey. General inspection: Is there cyanosis, is the patient pale, in pain, or has breathing difficulty Are there open wounds, bleeding, foreign bodies, bruising, swelling, and signs of bony deformity in the lower thorax or pelvis Palpation: Observe pain on palpation of the abdomen, including its bony borders at the lower rib cage and pelvis (see Chapter 18). Initial percussion findings are unlikely to reveal serious pathology in the timeframe immediately after the injury, though pain may be elicited. Auscultation: Auscultation of the abdomen will probably reveal normal bowel sounds. Bowel sounds can be auscultated in the thorax in the presence of a diaphragmatic injury or a large pneumothorax (see Chapter 16). Remember: the back of the abdomen must also be inspected, palpated, and auscultated once the patient has been turned into the recovery position. Management: this usually involves stabilizing the patient and transferring to the fieldside for further evaluation. A better examination can usually be conducted in the more secluded environs of the athlete medical room. Administer high-flow oxygen at 15 L/min by facemask if the athlete is hypoxic and titrate the oxygen to keep saturation (SpO2) between 94% and 98% if a pulse oximeter is attached. Abdominal Wall Injuries Blows to the abdominal wall are not infrequent in sport and can be seen with "winding" or "solar plexus" punches. They may result in contusions in the abdominal wall muscles (usually the rectus abdominis muscle). Other injuries, such as lateral and rotatory stretching injuries, sudden explosive weight lifting, and hyperextension of the spine can cause partial muscle tears and contusions. Tennis players often suffer from myalgia in the rectus and transversus muscles, usually due to the rotations during serving. The diagnosis of myalgia is usually straightforward as the pain is often superficial and can be easily provoked by stretching the affected muscle. Tightening of the abdominal muscles will often cause discomfort in an abdominal wall lesion. At times, it can be difficult to differentiate between abdominal wall injuries and underlying minor organ injury, so beware! Some athletes, particularly unconditioned athletes or ones who have recently eaten, may experience lateral abdominal pain while running, so-called "side cramps" or "side stitches", or more precisely "exercise-related transient abdominal pain". The cause of this phenomenon is unknown and has previously assumed to be due to muscle cramping, though recent evidence seems to suggest that this is not the case. Diaphragmatic ischemia and rapid increase in hepatic venous flow have also been proposed as likely causes. There is no treatment for the condition, other than moral support and patience as the condition usually resolves itself within a few minutes. Winding Winding is a relatively common injury in contact sports resulting from a blow to the "solar plexus" of the abdomen. The exact pathophysiological mechanism is unknown; however, it is thought that external forces cause vagal stimulation and resultant temporary diaphragmatic spasm. Typically, the winded athlete doubles up and has difficulty breathing with short gasping breaths. As with "side cramps" the situation resolves itself quickly without any residual symptoms.
It may also occur in syndromes causing predominantly axial (as opposed to limb) rigidity. This nuchocephalic - 241 - N Nyctalopia reflex is present in infants and children up to the age of about 4 years. Beyond this age the reflex is inhibited, such that the head is actively turned in the direction of shoulder movement after a time lag of about half a second. Cross References Age-related signs; Primitive reflexes Nyctalopia Nyctalopia, or night blindness, is an impairment of visual acuity specific to scotopic vision, implying a loss or impairment of rod photoreceptor function. Patients may spontaneously complain of a disparity between daytime and nocturnal vision, in which case acuity should be measured in different ambient illumination. The nature of the nystagmus may permit inferences about the precise location of pathology. Observations should be made in the nine cardinal positions of gaze for direction, amplitude, and beat frequency of nystagmus. However, since it is the slow phase which is pathological, it is more eloquent concerning anatomical substrate. The intensity of jerk nystagmus may be classified by a scale of three degrees: 1st degree: present when looking in the direction of the fast phase; 2nd degree: present in the neutral position; 3rd degree: present when looking in the direction of the slow phase. Pendular or undulatory nystagmus: In which the movements of the eyes are more or less equal in amplitude and velocity (sinusoidal oscillations) about a central (null) point. This is often congenital, may be conjugate or disconjugate (sometimes monocular), but is not related to concurrent internuclear ophthalmoplegia or asymmetry of visual acuity. A slow phase with exponentially increasing velocity (high-gain instability, runaway movements) may be seen in congenital or acquired pendular nystagmus. The pathophysiology of acquired pendular nystagmus is thought to be deafferentation of the inferior olive by lesions of the red nucleus, central tegmental tract, or medial vestibular nucleus. Central vestibular: unidirectional or multidirectional, 1st, 2nd or 3rd degree; typically sustained and persistent. Cerebellar/brainstem: commonly gaze-evoked due to a failure of gaze-holding mechanisms. Congenital: usually horizontal, pendular-type nystagmus; worse with fixation, attention, and anxiety. Many pathologies may cause nystagmus, the most common being demyelination, vascular disease, tumour, neurodegenerative disorders of cerebellum and/or brainstem, metabolic causes. Pendular nystagmus may respond to anticholinesterases, consistent with its being a result of cholinergic dysfunction. Periodic alternating nystagmus responds to baclofen, hence the importance of making this diagnosis. These symptoms are thought to reflect critical compromise of optic nerve head perfusion and are invariably associated with the finding of papilloedema. Obscurations mandate urgent investigation and treatment to prevent permanent visual loss. Cross Reference Papilloedema Obtundation Obtundation is a state of altered consciousness characterized by reduced alertness and a lessened interest in the environment, sometimes described as psychomotor retardation or torpor. An increased proportion of time is spent asleep and the patient is drowsy when awake. Cross References Coma; Psychomotor retardation; Stupor Ocular Apraxia Ocular apraxia (ocular motor apraxia) is a disorder of voluntary saccade initiation; reflexive saccades and spontaneous eye movements are preserved. Ocular apraxia may be overcome by using dynamic head thrusting, with or without blinking (to suppress vestibulo-ocular reflexes): the desired fixation point is achieved through reflex contraversive tonic eye movements to the midposition following the overshoot of the eyes caused by the head thrust. Cross References Apraxia; Saccades Ocular Bobbing Ocular bobbing refers to intermittent abnormal vertical eye movements, usually conjugate, consisting of a fast downward movement followed by a slow return to the initial horizontal eye position.