Vitamin D and incident urinary incontinence in older adults.

BACKGROUND/OBJECTIVES: The aim of this study is to determine whether vitamin D status is associated with incident urinary incontinence (UI) among community-dwelling older adults. SUBJECTS/METHODS: The University of Alabama at Birmingham Study of Aging is a prospective cohort study of community-dwelling Medicare enrollees. Standardized assessment of UI was conducted using the validated Incontinence Severity Index. The analysis of 25-hydroxyvitamin D [25(OH)D] levels was performed on stored baseline sera. UI was assessed every 6-12 months for up to 42 months. The analyses included multivariable logistic regression and Cox proportional hazard models. RESULTS: Of 350 participants (175 male, 147 black, mean age 73.6±5.8), 54% (189/350) were vitamin D deficient (25(OH)D <20 ng/ml) and 25% (87/350) were vitamin D insufficient (25(OH)D: 20 ng/ml to <30 ng/ml). Among the 187 subjects with no UI at baseline, 57% (107/187) were vitamin D deficient and 24% (45/187) were vitamin D insufficient. A total of 175 of the 187 subjects had follow-up evaluation for incident UI over 42 months, and incident UI occurred in 37% (65/175). After adjustment, cumulative incident UI at 42 months was associated with baseline vitamin D insufficiency (P=0.03) and demonstrated a trend association with deficiency (P=0.07). There was no association between baseline vitamin D status and the time to incident UI. CONCLUSIONS: These preliminary results support an association between vitamin D and incident UI in community-dwelling older adults. Future studies may target specific at-risk groups, such as men with BPH or women with pelvic floor disorders for evaluation of the impact of vitamin D supplementation on urinary symptoms.

Behavioral therapy to treat urinary incontinence in Parkinson disease.

OBJECTIVE: To assess the feasibility and efficacy of exercise-based behavioral therapy to treat urinary incontinence (UI) in older adults with Parkinson disease (PD). METHODS: Participants with PD ≥50 years with ≥4 UI episodes on a 7-day bladder diary were recruited from movement disorders clinics. In 5 visits over 8 weeks, participants learned pelvic floor muscle exercises using computer-assisted EMG biofeedback, and bladder control strategies including urge suppression. Bladder diaries were used to reinforce techniques and monitor the primary outcome of UI frequency. Secondary outcomes included additional reporting of lower urinary tract symptoms, symptom bother, and quality of life (QOL) using the International Consultation on Incontinence Questionnaire for overactive bladder (ICIQ-OAB). RESULTS: Twenty participants were enrolled (90% male, age 66.5 ± 6.2 [mean ± SD], with PD for 6.9 ± 5.4 years) and 17 completed the study. The median (interquartile range) weekly frequency of baseline UI episodes was 9 (4-11) and following intervention was 1 (0-3), representing an 83.3% reduction (45.5-100.0, p = 0.0001). QOL scores on the ICIQ-OAB improved from 71.1 ± 23.9 to 54.7 ± 15.4 (p = 0.002). CONCLUSIONS: In this uncontrolled pilot study of an exercise-based, biofeedback-assisted behavioral intervention, older participants with PD demonstrated statistically significant and clinically meaningful reductions in frequency of UI and improvement in QOL. Randomized controlled trials to assess behavioral therapies for UI in patients with PD are warranted. CLASSIFICATION OF EVIDENCE: This study provides Class IV evidence that exercise-based, biofeedback-assisted behavioral intervention can reduce UI frequency in patients >50 years old with PD.

The association of nocturia with incident falls in an elderly community-dwelling cohort.

OBJECTIVE: The aim of this study was to examine the association of nocturia with incident falls in a population-based sample of community-dwelling elderly persons. METHODS: The University of Alabama at Birmingham Study of Aging is a prospective cohort study of 1000 community-dwelling older adults in the USA designed to examine factors associated with impaired mobility. Subjects were recruited from a stratified, random sample of Medicare beneficiaries to include equal numbers of black women, black men, white women and white men. Nocturia was assessed at baseline and falls were assessed at baseline and every 6 months for a total of 36 months of follow-up. RESULTS: A total of 692 individuals (mean age 74.5 +/- 6.2, 48% female, 52% black) did not fall in the 12 months prior to baseline. Of these 692, 214 (30.9%) reported falling at least once during the subsequent 3 years. In unadjusted analysis, three or more nightly episodes of nocturia were associated with an incident fall [RR = 1.27, 95% CI (1.01-1.60)]. After multivariable logistic regression, three or more episodes of nocturia were associated with an increased risk of falling [RR = 1.28, (1.02-1.59)]. DISCUSSION: In a racially diverse, community-based sample of older men and women who had not fallen in the previous year, nocturia three or more times a night was associated in multivariable analysis with a 28% increased risk of an incident fall within 3 years. While this study has several advantages over previous reports (longitudinal follow-up, performance-based measures of function, population-based sampling), causality cannot be ascertained. Further research is needed to ascertain the impact of treatments to reduce nocturia as part of a multi-component programme to reduce fall risk.

Psychological improvements associated with behavioral and drug treatment of urge incontinence in older women.

The purpose of this study was to explore changes in psychological distress associated with behavioral treatment and drug treatment for urge incontinence in community-dwelling older women. Participants were 197 ambulatory, nondemented women (aged 55 years or older) with persistent urge urinary incontinence. Participants were patients in a randomized clinical trial comparing biofeedback-assisted behavioral treatment, drug treatment with oxybutynin chloride, and a placebo-control condition. Psychological distress was measured before and after treatment using the Hopkins Symptom Checklist (SCL-90-R). Multivariate and univariate analyses of variance showed that the two treatment groups and the control group had similar significant improvements on the nine subscales and the global severity index. Analysis of individual SCL-90-R subscale scores revealed trends suggesting that behavioral treatment tended to produce the largest improvements. The reductions of distress were not correlated consistently with reduction of incontinence. The results of this study showed that psychological distress was significantly reduced after treatment, regardless of the type of treatment.

Reliability assessment of the bladder diary for urinary incontinence in older women.

BACKGROUND: A reliable method of documenting the frequency of incontinent episodes is essential for assessment of treatment outcome in both clinical practice and research studies. Bladder diaries, completed prospectively by the patient, have been widely used for this purpose. This study investigated the number of consecutive days of bladder diary reports of incontinence frequency necessary to obtain adequate internal consistency (reliability). METHODS: Participants were 214 community-dwelling women, aged 40 to 90 years, with a history of stress, urge, or mixed urinary incontinence, persisting at least 3 months with a frequency of two or more episodes of urine leakage per week. Each participant kept a 14-day bladder diary documenting the time and circumstances of each incontinence episode. RESULTS: The mean age of participants was 63.5 years; 16.9% were African American. Women with predominantly urge incontinence (n = 138) reported a daily frequency of 2.1 incontinent episodes. Although there was a statistically significant difference between Week 1 (2.4 episodes per day) and Week 2 (2.0 episodes per day; p < .0001), five days were necessary to obtain an internal consistency of .90 for Cronbach's alpha. Women with predominantly stress incontinence (n = 76) had no statistical difference between Week 1 and Week 2 in frequency of incontinence, reporting an average 2.2 accidents per week in Week 1 and 2.1 in Week 2. However, 7 days of bladder diary were required before adequate internal consistency was reached. CONCLUSION: Seven consecutive days of bladder diary provides a stable and reliable measurement of the frequency of incontinence episodes in community-dwelling women.

Measurement of postvoid residual urine with portable transabdominal bladder ultrasound scanner and urethral catheterization.

The study was a clinical series of 95 ambulatory women with urinary incontinence. After voiding, each subject was scanned with a BladderScan BVI 2500, then catheterized for postvoid residual (PVR) and then scanned again. The mean PVR obtained by ultrasound was 49 ml, significantly larger than the mean PVR of 32 ml obtained by catheterization. Correlation analysis showed that the difference was not related to age, weight, body mass index, parity, pelvic prolapse or prior incontinence surgery, but was associated with prior hysterectomy and uterine prolapse. Regression analysis revealed that the difference was independently related to prior hysterectomy only. Postcatheterization ultrasound detected a mean of 22 ml, suggesting that the difference between the PVR values may be due to residual urine not removed by catheterization. Finally, ultrasound had a sensitivity of 66.7% and a specificity of 96.5% in detecting PVR > or = 100 ml. Portable ultrasound scanners are quick, easy to use, reasonably sensitive, and very specific for determining elevated PVR.

Combined behavioral and drug therapy for urge incontinence in older women.

OBJECTIVE: The purpose of this study was to examine the effects of combining behavioral treatment and drug treatment for urge incontinence in community-dwelling older women. DESIGN: Modified crossover design (extension of a randomized clinical trial). Eligible subjects were stratified according to type and severity of incontinence and randomized to behavioral treatment, drug treatment, or a control condition (placebo). Subjects not totally continent or not satisfied after 8 weeks of a single treatment were offered the opportunity to cross over into combined therapy. SETTING: A university-based outpatient geriatric medicine clinic. PARTICIPANTS: Subjects in the clinical trial were 197 ambulatory, nondemented, community-dwelling women (age 55 years or older) with persistent urge urinary incontinence. Thirty-five subjects participated in combined treatment. INTERVENTION: One group of subjects received four sessions (over 8 weeks) of biofeedback-assisted behavioral training followed by 8 weeks of behavioral training combined with drug therapy (oxybutynin chloride individually titrated from 2.5 mg to 15 mg daily). The second group received drug therapy first, followed by 8 weeks of drug therapy combined with behavioral training. MEASUREMENTS: Bladder diaries completed by subjects before and after each treatment phase were used to calculate change in the frequency of incontinent episodes. RESULTS: Eight subjects (12.7%) crossed from behavioral treatment alone to combined behavioral and drug therapy. Additional benefit was seen in improvement from a mean 57.5% reduction of incontinence with single therapy to a mean 88.5% reduction of incontinence with combined therapy (P = .034). Twenty-seven subjects (41.5%) crossed from drug therapy alone to combined drug and behavioral treatment. They also showed additional improvement, from a mean 72.7% reduction of incontinence with single therapy to a mean 84.3% reduction of incontinence with combined therapy (P = .001). CONCLUSIONS: This study shows that combining drug and behavioral therapy in a stepped program can produce added benefit for patients with urge incontinence.

Pressure ulcers, hospital complications, and disease severity: impact on hospital costs and length of stay.

OBJECTIVE: To determine whether or not the development of a Stage II or greater pressure ulcer in-hospital is associated with increased hospital costs and length of stay after adjusting for admission severity of illness, comorbidities, nosocomial infections, and other hospital complications. DESIGN: Prospective, inception cohort study. SETTING: Tertiary care, urban, university teaching hospital. PARTICIPANTS: 286 patients identified within 3 days of admission to a tertiary care, urban teaching hospital were enrolled in a prospective, inception cohort study. Patients were age 55 or greater; expected to be confined to bed or chair or with a hip fracture; and expected to remain in hospital at least 5 days. MEASUREMENTS: Baseline data were collected within 3 days of admission. Weekly skin assessments were performed by study nurses to document the development of pressure ulcers. Medical record reviews, patient exams, and physician and nurse interviews were used to obtain baseline demographic, medical, functional, nutritional, and global measures of disease severity. The incidence of nosocomial infections and the number of other hospital complications were monitored by medical record reviews. Hospital costs were estimated using category-specific cost-to-charge ratios. Diagnostic-related group (DRG) adjusted length of stay was calculated by subtracting the mean length of stay for assigned DRGs from actual stays. RESULTS: Incident pressure ulcers were associated with significantly higher mean unadjusted hospital costs ($37,288 vs $13,924, P = 0.0001) and length of stay (30.4 vs 12.8 days, P = 0.0001). In addition to pressure ulcers, other independent predictors of hospital costs and length of stay after multivariable analyses included: admission to an intensive care unit or surgical service, younger age, nosocomial infection, the physician assessment of disease severity, and the number of other hospital complications. Compared with those who did not develop pressure ulcers, patients who developed pressure ulcers also were more likely to develop nosocomial infections (45.9% [17/37] vs 20.1% [50/249], P = 0.001) and other hospital complications (86.5% [32/37] vs 43.0% [107/249], P < 0.001). After adjusting for only the admission predictors of costs and length of stay by multivariable analyses, hospital costs, and length of stay for those who developed pressure ulcers remained significantly greater than for those who did not develop pressure ulcers ($14,260 vs $12,382, P = 0.03, and 16.9 vs 12.9 days, P = 0.02, respectively). The differences in costs and length of stay for those with and without incident pressure ulcers were even greater when adjusted for admission predictors and also the occurrence of nosocomial infections and other complications ($29,048 vs $13,819, P = 0.002, and 20.9 vs 12.7 days, P = 0.0001, respectively). CONCLUSION: Incident pressure ulcers are associated with substantial and significant increases in hospital costs and length of stay. Nosocomial infections and other hospital complications are additional significant independent predictors of health care utilization among patients at risk for pressure ulcers.

A comparison of an opaque foam dressing versus a transparent film dressing in the management of skin tears in institutionalized subjects.

Epidemiological studies suggest that at least 1.5 million skin tears occur each year in institutionalized adults. Despite this incidence, very little is known about the management of skin tears in elderly persons. Studies related to wound dressings and healing rates for these skin tears have rarely been reported in the medical literature. A randomized, prospective trial of 37 subjects compared the treatment of skin tears using either an opaque foam dressing or a transparent film dressing. Subjects had either a modified Payne-Martin Category II (25%-75% epidermal loss) or Category III (100% epidermal loss) skin tear. Category I skin tears (linear with no tissue loss) and skin tears greater than 48 hours old were excluded. Mean subject age was 85.1 +/- 9.7 years. Subjects were followed weekly until healed or for up to 21 days. Subjects in the comparison groups did not differ at baseline in age, sex, wound severity score, presence of diabetes, nutrition score, ambulation and mobility score, or mental status score. Complete healing occurred in 94% (16/17) of subjects treated with the foam dressing as opposed to 65% (11/17) of subjects treated with the film dressing (P < 0.05). Complete healing correlated only with dressing type (P < 0.05) and age (P < 0.01). No other factor was associated with the healing outcome. The number of dressing changes was similar in each group, 3.1 +/- 1.2 versus 3.4 +/- 1.1. Based on the results of this study, we conclude that this opaque foam dressing is a superior wound dressing for skin tears.

Behavioral vs drug treatment for urge urinary incontinence in older women: a randomized controlled trial.

CONTEXT: Urinary incontinence is a common condition caused by many factors with several treatment options. OBJECTIVE: To compare the effectiveness of biofeedback-assisted behavioral treatment with drug treatment and a placebo control condition for the treatment of urge and mixed urinary incontinence in older community-dwelling women. DESIGN: Randomized placebo-controlled trial conducted from 1989 to 1995. SETTING: University-based outpatient geriatric medicine clinic. PATIENTS: A volunteer sample of 197 women aged 55 to 92 years with urge urinary incontinence or mixed incontinence with urge as the predominant pattern. Subjects had to have urodynamic evidence of bladder dysfunction, be ambulatory, and not have dementia. INTERVENTION: Subjects were randomized to 4 sessions (8 weeks) of biofeedback-assisted behavioral treatment, drug treatment (with oxybutynin chloride, possible range of doses, 2.5 mg daily to 5.0 mg 3 times daily), or a placebo control condition. MAIN OUTCOME MEASURES: Reduction in the frequency of incontinent episodes as determined by bladder diaries, and patients' perceptions of improvement and their comfort and satisfaction with treatment. RESULTS: For all 3 treatment groups, reduction of incontinence was most pronounced early in treatment and progressed more gradually thereafter. Behavioral treatment, which yielded a mean 80.7% reduction of incontinence episodes, was significantly more effective than drug treatment (mean 68.5% reduction; P=.04) and both were more effective than the placebo control condition (mean 39.4% reduction; P<.001 and P=.009, respectively). Patient-perceived improvement was greatest for behavioral treatment (74.1% "much better" vs 50.9% and 26.9% for drug treatment and placebo, respectively). Only 14.0% of patients receiving behavioral treatment wanted to change to another treatment vs 75.5% in each of the other groups. CONCLUSION: Behavioral treatment is a safe and effective conservative intervention that should be made more readily available to patients as a first-line treatment for urge and mixed incontinence.

Acemannan hydrogel dressing versus saline dressing for pressure ulcers. A randomized, controlled trial.

Aloe vera has been used for centuries as a topical treatment for various conditions and as a cathartic. An amorphous hydrogel dressing derived from the aloe plant (Carrasyn Gel Wound Dressing, Carrington Laboratories, Inc., Irving, TX) is approved by the Food and Drug Administration for the management of Stages I through IV pressure ulcers. To evaluate effectiveness of this treatment, 30 patients were randomized to receive either daily topical application of the hydrogel study dressing (acemannan hydrogel wound dressing) or a moist saline gauze dressing. Complete healing of the study ulcer occurred in 19 of 30 subjects (63%) during the 10-week observation period. No difference was observed in complete healing between the experimental and the control groups (odds ratio 0.93, 95% CI 0.16, 5.2). This study indicates that the acemannan hydrogel dressing is as effective as, but is not superior to, a moist saline gauze wound dressing for the management of pressure ulcers.

Behavioral interventions for incontinence in ambulatory geriatric patients.

Behavioral intervention is a group of therapies used to modify stress, urge, or mixed urinary incontinence by changing patient bladder habits or by teaching new skills. Three broad categories of behavioral treatment are reviewed: pelvic muscle exercise, biofeedback, and bladder training. The literature concerning each of these methods indicates that the treatments are effective for most community-dwelling older adults. More research is needed to identify the best methods for implementing these treatments, to explore the role of various components of treatment packages, to examine issues of durability, and to improve adherence to behavioral protocols necessary for long-term effectiveness.

Pharmacologic treatment of lower urinary tract dysfunction in geriatric patients.

Medications to treat lower urinary tract dysfunction in older adults are selected to alter specific physiologic parameters. Pharmacotherapy alone results in modest clinical improvement. Because of the high prevalence of adverse drug reactions and polypharmacy in the geriatric population, medication should be used for those conditions that do not respond sufficiently to behavioral therapy. For stress incontinence, medications with alpha-adrenergic agonist properties are the mainstay of pharmacotherapy because they increase outlet resistance. Pharmacotherapy of urinary frequency and urge incontinence aims to decrease detrusor irritability and increase bladder capacity by inhibiting cholinergic stimulation of the bladder. In addition to these medications, in postmenopausal women, estrogen seems to have an additive effect for both urge and stress incontinence. More randomized, placebo-controlled, double-blinded clinical trials are needed that compare various pharmacologic agents and combinations, as well as pharmacotherapy with other forms of treatment for lower urinary tract dysfunction.

Pressure ulcers. Local wound care.

Local care of pressure ulcers includes wound cleansing, débridement, and dressings. Wound cleansing should remove loose debris and exudate but should not damage viable tissue. Saline irrigation is the standard. Débridement is often necessary for Stage III and IV pressure ulcers and can be performed autolytically, mechanically, enzymatically, or sharply. Prompt débridement is essential for infected wounds. Dressings should keep the wound bed continuously moist, should not be toxic to granulation tissue, and should keep the surrounding intact skin dry. Randomized, controlled clinical trials are necessary to define optimal local wound care further.

Hospital-acquired pressure ulcers and risk of death.

OBJECTIVE: To evaluate the impact of in-hospital pressure ulcer development on mortality among older, high-risk, hospitalized patients up to 1 year post-hospital discharge, after adjusting for baseline patient characteristics, disease severity, hospital complications, and discharge activity level. DESIGN: A prospective, inception, cohort study. SETTING: An urban, tertiary, acute care, university teaching hospital. PATIENTS: A total of 286 patients aged 55 or older, expected to be confined to bed or chair for at least 5 days, who were admitted to the hospital without a Stage 2 or greater pressure ulcer. MEASUREMENTS: The primary outcome measurement was time to death from admission to 1-year post-hospital discharge. Baseline information included demographic, medical, functional, and nutritional variables known to be associated with increased mortality. Measures of global disease severity and co-morbidity included the admitting physician's estimate of illness severity and life expectancy, the acute physiology score of APACHE II, the Co-morbidity Damage Index, and the Medicus Nursing Classification Score. Baseline infections, incident infections, and noninfectious hospital complications were determined. Functional activity level was determined at hospital discharge. Post-discharge vital status was determined by telephone interviews at 3,6,9, and 12 months after discharge and confirmed by death certificate review. MAIN RESULTS: Development of an in-hospital pressure ulcer was associated with greater risk of death at 1 year (59.5% vs 38.2%, P = .02). However, pressure ulcer development did not remain independently associated with decreased survival after adjusting for other predictors of mortality. Predictors of mortality at hospital admission by multivariate Cox regression analysis included weight loss in the 6 months before admission (RR 2.4, CI 1.6, 3.6), physician estimate of life expectancy (RR 2.1, CI 1.7, 2.6), and the Co-morbidity Damage Index (RR 1.1, CI 1.0, 1.2). Multivariate predictors of 1-year mortality at discharge included physician estimate of life expectancy (RR 2.2, CI 1.8,2.6), weight loss in the 6 months before admission (RR 2.2, CI 1.5,3.2), remaining confined to bed or chair (RR 1.9, CI 1.2,3.1), and the total number of hospital complications (RR 1.3, CI 1.2,1.5). CONCLUSIONS: Pressure ulcers that develop during acute hospitalization are not associated with reduced 1-year survival among high risk older persons after adjusting for nutritional and functional status, global measures of disease severity and co-morbidity, and noninfectious hospital complications.

Pressure ulcer risk factors among hospitalized patients with activity limitation.

OBJECTIVE: To identify specific demographic, medical, functional status, and nutritional characteristics that predict the development of stage 2 or greater pressure ulcers among patients whose activity is limited to bed or chair. DESIGN: Prospective inception cohort study. SETTING: Tertiary care, urban, university teaching hospital. PATIENTS: A total of 286 patients fulfilling the following criteria: admitted to the hospital within the previous 3 days, age 55 years or more, expected to be confined to bed or chair for at least 5 days or had a hip fracture, and without a stage 2 or greater pressure ulcer. MAIN OUTCOME MEASURE: Time to in-hospital development of a stage 2 or greater pressure ulcer. RESULTS: Total cumulative incidence of pressure ulcers was 12.9% (n = 37) after a median time of 9 days from admission to final skin examination. Age of 75 years or more, dry skin, nonblanchable erythema (a stage 1 pressure ulcer), previous pressure ulcer history, immobility, fecal incontinence, depleted triceps skinfold, lymphopenia (lymphocyte count < 1.50 x 10(9)/L), and decreased body weight (< 58 kg) were significantly associated with pressure ulcer development by univariate Kaplan-Meier survival analyses (P < .05 by log-rank test). Risk ratios (and 95% confidence intervals) for predictors (P < or = .05) of pressure ulcer development after multivariable Cox regression analysis included the following: nonblanchable erythema, 7.52 (1.00 to 59.12); lymphopenia, 4.86 (1.70 to 13.89); immobility, 2.36 (1.14 to 4.85); dry skin, 2.31 (1.02 to 5.21); and decreased body weight, 2.18 (1.05 to 4.52). The 3-week cumulative incidence of pressure ulcers with none, one, two, or three or more of these characteristics was 0%, 11.4%, 39.6%, and 67.9%, respectively (P < .001 by log-rank test). CONCLUSIONS: These results suggest that nonblanchable erythema, lymphopenia, immobility, dry skin, and decreased body weight are independent and significant risk factors for pressure ulcers in hospitalized patients whose activity is limited to bed or chair.

Tissue repair processes in healing chronic pressure ulcers treated with recombinant platelet-derived growth factor BB.

Cellular and molecular mechanisms responsible for the observed vulnerary effects of recombinant human platelet-derived growth factor BB (rP-DGF-BB) in man have not been elucidated. In a double-blinded trial, patients having chronic pressure ulcers were treated topically with either rPDGF-BB or placebo for 28 days. To explore how rPDGF-BB may induce chronic wounds to heal, biopsies were taken from the ulcers of a cohort of 20 patients from the trial and evaluated in a blinded fashion by light microscopy for 1), fibroblast content, 2) neovessel formation, and 3), collagen deposition. Electron microscopy also was used to assess fibroblast activation and collagen deposition. Before initiation of therapy most wounds had few fibroblasts and most of those present were not activated. When mean scores for the total active treatment phase (days 8, 15, and 29) for rPDGF-BB-treated ulcers were compared with the scores for placebo-treated ulcers, fibroblast content was significantly higher for the rPDGF-BB-treated ulcers (P = 0.03, Kruskal-Wallis test). More significant differences in fibroblast and neovessel content were observed when six nonhealing wounds were eliminated from the analysis (three placebo, three treatment). Thus, in all healing wounds, rPDGF-BB therapy significantly increased fibroblast (P = 0.0007) and neovessel (P = 0.02) content. These results were correlated with increased collagen fibrillogenesis by fibroblasts from healing rPDGF-BB-treated wounds, as assessed by intracellular procollagen type I immunostaining, and by electron microscopy, and were concordant with clinical measurements (eg, area of ulcer opening and ulcer volume) which showed greater healing in rPDGF-BB-treated wounds. These results suggest induction of fibroblast proliferation and differentiation is one mechanism by which rPDGF-BB can accelerate wound healing and that rPDGF-BB can augment healing responses within a majority of, but not all, nonhealing chronic pressure ulcers in man.

A phase II study to evaluate recombinant platelet-derived growth factor-BB in the treatment of stage 3 and 4 pressure ulcers.

OBJECTIVE: To determine the efficacy of the daily topical application of recombinant platelet-derived growth factor-BB (rPDGF-BB), a recognized vulnerary agent, in the treatment of deep pressure ulcers. DESIGN: Prospective, randomized, double-blind trial. SETTING: Patients were treated in a nursing home or a hospital setting before transfer to a nursing home. PATIENTS: Eligibility criteria included a clean pressure ulcer that had been adequately debrided and the absence of severe cardiac, pulmonary, or renal conditions. The causes of the ulcers were not related to a venous or arterial vascular disorder. The patients were elderly (mean age, 68 to 74 years). INTERVENTIONS: After randomization, patients were given daily topical aqueous rPDGF-BB (dosage, 100 or 300 micrograms/mL) or placebo and saline gauze dressings were applied daily in addition to frequent turning. MAIN OUTCOME MEASURE: Serial volume measurements of the healing wounds were taken using alginate molds. RESULTS: The ulcers of 41 patients were analyzed. At the end of 28 days, median ulcer volumes had decreased to 83%, 29%, and 40% of the initial size in the groups receiving placebo, rPDGF-BB, 100 micrograms/dL, and rPDGF-BB, 300 micrograms/mL, respectively. When adjusted for initial volume, ulcer volume after 28 days of treatment was smaller in the rPDGF-BB-treated groups compared with the placebo group (analysis of covariance, P = .056). Ulcers in the two rPDGF-BB-treated groups were significantly smaller in volume compared with those in the placebo group, using a linear contrast procedure. CONCLUSIONS: Data from this small trial suggest that local application of rPDGF-BB may be of therapeutic benefit in accelerating the healing of chronic pressure ulcers.

The prevention and management of pressure ulcers.

Pressure ulcers are a common problem for older persons. Complications associated with pressure ulcers include infection and even death for some patients. Pressure is the primary pathogenic factor, but shearing forces, friction, and moisture are also important. Immobility, nutritional status, and age-related factors seem to be significant risk factors. Preventive care includes use of assessment tools to identify high risk patients, frequent repositioning, air or foam mattresses that reduce pressure over bony prominences, as well as careful attention to optimizing the overall patient condition. When pressure ulcers do develop, the treatment plan should include adequate nutrition including protein, vitamin C, and zinc supplements as indicated; systemic antibiotics for sepsis, cellulitis, osteomyelitis, or the prevention of bacterial endocarditis; and local wound care that eliminates necrotic tissue, decreases bacterial load, and provides a physiologic, pressure-free environment allowing the wound to heal. Specialized beds may be considered in some patients, particularly those with larger ulcers. Surgery is an option in older persons who are operative candidates. For some patients with pressure ulcers, appropriate treatment goals may focus on providing comfort rather than curing the ulcer.