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Biomedical subjects

R L Rutan

Publications and source records attributed to R L Rutan.

At least 19 recordsLinked to original sources
PubMed1997

Academic surgeons' knowledge of Food and Drug Administration regulations for clinical trials.

OBJECTIVES: To identify knowledge levels of academic surgeons about Food and Drug Administration (FDA) and Institutional Review Board (IRB) regulations for clinical research and to determine whether being a member in an IRB, conducting or participating in clinical trials, or being a member in surgical societies affected knowledge levels. DESIGN: Survey of surgical department faculty members in 20 universities. RESULTS: Sixty-five responses were received from 14 sites. Overall mean (+/- SEM) correct score was 6.7 +/- 0.2 of a possible 20 points. The best predictor of overall score was being a primary investigator of a clinical trial (P < .001), followed by being or having been a member of an IRB (P < or = .02). The total mean score of members of the Surgical Infection Society (8.2 +/- 0.5) was significantly higher (P < .001) than that of nonmembers (6.1 +/- 0.2), a phenomenon not observed with other surgical societies. In certain hypothetical clinical scenarios, all respondents were mistakenly willing to conduct clinical trials without obtaining appropriate approval from the FDA. Four (22%) of 18 IRB member respondents and 16 (25%) of the 65 respondents were willing to conduct human research without appropriate approval from patients, the IRB, or both. CONCLUSIONS: Knowledge deficits exist in the academic surgical community about the role and requirements of the FDA and local IRBs for conducting clinical research. Further study is required to determine the reasons for this deficit and to identify appropriate interventions.

Clinical Trials as Topic↗
PubMed1994

Recent advances in burn care.

Over the past few decades, the mortality related to thermal injuries has been significantly reduced. This has been accomplished through an increased understanding and subsequent management of inhalation injury, the postburn hypermetabolic response, and immunocompromise. In addition, the prompt excision of the burn wound and early permanent closure has decreased the length of hospital stay and has facilitated timely social reintegration of the burned patient.

Burns↗
PubMed1994

Recombinant human growth hormone accelerates wound healing in children with large cutaneous burns.

OBJECTIVE: Two forms of recombinant growth hormone that accelerate the healing of skin graft donor sites in severely burned children were evaluated. SUMMARY BACKGROUND DATA: Growth hormone has been shown to reduce wound healing times in burned pediatric patients. Through genetic engineering, several different forms have been synthesized; however, not all are marketed currently. Two forms of growth hormone were used in these studies, Protropin (Genentech, Inc., San Francisco, CA), a commercially available product that possesses a N-terminal methionine residue not found in the second form Nutropin (Genentech, Inc., San Francisco, CA), which, as yet, is not commercially available. Through the use of recombinant human growth hormone, rapid wound healing may reduce the hypermetabolic period, the risk of infection, and accelerate the healing of donor sites used for grafting onto burned areas. The two structurally different forms of growth hormone were tested for their efficacy in healing donor sites in severely burned children. METHODS: Forty-six children, with a > 40% total body surface area and > 20% total body surface area full-thickness burn were entered in a double-blind, randomized study to receive rhGH within 8 days of injury. Twenty received (0.2 mg/kg/day) Nutropin or placebo by subcutaneous or intramuscular injection beginning on the morning of the initial excision. Eighteen patients who failed the entry criteria for receiving Nutropin received Protropin therapeutically (0.2 mg/kg/day). Donor sites were harvested at 0.006 to 0.010 inches in depth and dressed with Scarlet Red impregnated fine mesh gauze (Sherwood Medical, St. Louis, MO). The initial donor site healing time, in days, was reached when the gauze could be removed without any trauma to the healed site. RESULTS: Donor sites in patients receiving Nutropin (n = 20) or Protropin (n = 18) healed at 6.8 +/- 1.5 and 6.0 +/- 1.5 (mean +/- SD) days, respectively, whereas those receiving placebo (n = 26) had a first donor site healing time of 8.5 +/- 2.3 days. Both groups receiving rhGH showed a significant reduction in donor site healing time compared with placebo at p < 0.01. When subgroups were compared, no difference in healing times could be shown with regards to age or time of admission after injury. CONCLUSION: Our results indicate that both forms of rhGH are effective in reducing donor site healing time compared with placebo and suggest that accelerating wound healing is of clinical benefit because the patients' own skin becomes rapidly available for harvest and autografting. With this increase in the rate of wound healing, the total length of hospital stay can be reduced by more than 25%.

Adolescent↗
PubMed1992

Candida infection with and without nystatin prophylaxis. A 11-year experience with patients with burn injury.

The incidence of opportunistic infections after thermal injury is high. Since 1985, we have been practicing Candida prophylaxis using nystatin "swish-and-swallow" and topical therapy. Patients treated between 1980 and 1984 served as controls and received no Candida prophylaxis. Although mean burn size, full-thickness injury, and age were comparable, the incidence of Candida colonization (26.7% vs 15.6%), infection (21.3% vs 10.0%), and sepsis (12.2% vs none) was significantly different between control and nystatin-treated groups, respectively. With prophylaxis, the incidence of Candida wound infection has been significantly reduced, and systemic candidiasis has been eradicated, eliminating the need for toxic systemic antifungal agents.

Administration, Buccal↗
PubMed1992

Incidence of HIV seroconversion in paediatric burn patients.

A retrospective review of paediatric patients treated for acute burn injuries and receiving blood/blood products between 1978 and 1985, identified 52 patients at risk for HIV infection. Over 50 per cent of the identified population had received 3 or more units of blood/blood products during their acute hospital stay. A total of 214 patients (36.8 per cent) have been tested for HIV seroconversions: five tested HIV positive by ELISA and four were confirmed by Western Blot, yielding a 1.9 per cent incidence. The four confirmed patients received 2-9 total body blood volume turnovers during their postburn period in hospital. At 4 years post-exposure, two patients show active disease, one is currently asymptomatic and one has died from AIDS-related sepsis.

Adolescent↗
PubMed1992

Effect of prostaglandin E on immune function in normal healthy volunteers.

Prostaglandin E (PGE) has been hypothesized to be the endogenous metabolite that results in the immunosuppression seen in patients with tumor and trauma. This has resulted in multiple investigators proposing that administration of PGE inhibitors, such as aspirin and indomethacin, might improve immune function in such patients. We administered a long acting PGE analog, misoprostol, to nine normal healthy volunteers for five days and assayed immune function before and after therapy. The PGE analog improved lymphocyte blastogenesis and increased tumor necrosis factor production. The PGE analog also resulted in the volunteers having symptoms similar to those seen in patients with sepsis. The results of these studies indicate that elevated levels of PGE do not seem to result in impairment of immune function, but may be the endogenous metabolite responsible for the symptologic factors seen in infected patients.

Adult↗
PubMed1992

Effect of recombinant human growth hormone on catabolic hormones and free fatty acids following thermal injury.

Severe burn injury elicits the release of catabolic hormones that contribute to negative nitrogen balance, protein wasting, and impaired wound healing. Previous studies have shown that burn patients receiving recombinant human growth hormone (rhGH) therapy have an increase in the rate of skin donor site healing and a shorter hospital stay. The mechanism by which rhGH exerts its effects, however, is not clearly understood. This study examines the effects of rhGH on circulating levels of catabolic hormones and nonesterified fatty acids in pediatric burn patients. Patients with greater than 40% total body surface area burn were randomly assigned to receive placebo (n = 8) or 0.2 mg/kg/day rhGH (n = 6) throughout their hospitalization. All patients had early morning blood samples assessed for catecholamines (CAT), cortisol, insulin, glucagon, and free fatty acid (FFA) levels during a period of hypermetabolism. No differences could be demonstrated in age, burn size, postburn day of evaluation, resting energy expenditure per kilogram, respiratory rate, heart rate, respiratory quotient, serum cortisol, and serum glucose between placebo- and rhGH-treated patients. The rhGH-treated group did show a significant elevation (p less than 0.05) in insulin-like growth factor-1 (55.9 +/- 14.5 vs. 168 +/- 23.7 mU/mL), total catecholamines (1,817 +/- 177 vs. 1,117 +/- 137 pg/mL), norepinephrine (1,257 +/- 121 vs. 867 +/- 113 pg/mL), epinephrine (385 +/- 175 vs. 147 +/- 36 pg/mL), insulin (32.8 +/- 3.3 vs. 25.0 +/- 3.0 mU/mL), glucagon (215 +/- 18 vs. 158 +/- 22 pg/mL), and free fatty acids (0.74 +/- 0.01 vs. 0.59 +/- 0.04 mEq/L) compared with the placebo group (data expressed as mean +/- SE).(ABSTRACT TRUNCATED AT 250 WORDS)

Burns↗
PubMed1992

The effect of erythropoietin in normal healthy volunteers and pediatric patients with burn injuries.

BACKGROUND: Surgical procedures result in blood loss that can require replacement transfusions. Such therapy may result in multiple adverse sequelae, including transmission of infectious diseases and immune impairment. Alternative therapies are therefore desirable. METHODS: We evaluated the ability of recombinant human erythropoietin (rEPO) to increase red blood cell production in both normal healthy volunteers and patients with burn injuries. The effect of rEPO on immune function in the volunteers was also evaluated. The volunteers received 150 units/kg rEPO daily for 7 days, with immune function and hematopoiesis assayed on days 0, 7, and 14. The patients with burn injuries received either 500 units/kg/day rEPO with iron supplementation or merely the iron. RESULTS: rEPO increased erythropoiesis in both the volunteers and the patients with burn injuries. Failure to provide iron supplementation to the volunteers resulted in significant depletion of iron stores with a concomitant impairment in immune function that paralleled the iron depletion. CONCLUSIONS: rEPO therapy offers the potential to increase red blood cell production in surgical patients. Failure to provide iron supplementation in patients receiving rEPO can lead to a rapid depletion of iron stores and may contribute to an immune dysfunction.

Adult↗
PubMed1991

Class C firework injuries in a pediatric population.

Class C fireworks are those which can be readily purchased by the public. Between July 1971 and August 1988, 23 patients were admitted to our institution with firework injuries. Fourteen patients (60.9%) sustained injuries related to Class C fireworks. All patients were males with a mean age of 9.0 +/- 3.6 years, with a total body surface area (TBSA) burn of 18 +/- 20% with 10 +/- 15% being full thickness. Thirteen of the 14 patients required hospitalization. Five patients were admitted acutely and eight patients were referred to our institution at least 3 days postinjury. All patients required operative intervention in order to obtain wound closure. Patients admitted acutely showed a decrease in length of hospital stay and patient morbidity when compared to referral patients. Our data suggest that class C firework injuries, although small in terms of TBSA burned, result in full-thickness wounds that warrant aggressive surgical management.

Burns↗
PubMed1991

Ischemic intestinal complications in patients with burns.

Enteral bacterial translocation has been implicated as a major cause of morbidity in instances of trauma, but little clinical evidence of the loss of intestinal mucosal integrity has been documented. A retrospective review of the medical and autopsy records of all patients admitted between 1982 and 1988 was performed to describe the incidence of intestinal pathologic findings. Of all deaths, a total of 53 per cent of adults (greater than 18 years old) and 61 per cent of children (zero to 17 years old) were noted to have ischemic intestinal pathologic findings on autopsy, ranging from superficial necrosis to full thickness mucosal necrosis extending into the omentum. More than 80 per cent of these patients were septic at the time of death, with endogenous intestinal flora species most frequently identified as the causative agent. Less than 1 per cent (n = 16) of the patients admitted were clinically identified with intestinal pathologic examination, surgically explored and underwent resection of the intestine. Despite intervention, this group suffered a 69 per cent mortality rate. Although the documentation of bacterial translocation in a human model may be obscured by other potential sources of contamination, for example, burn wound, in combination with the immunosuppression inherent to the thermally injured, may lead to bacterial contamination of the systemic circulation and, therefore, may be a significant contributor to morbidity and mortality after thermal injury.

Adolescent↗
PubMed1990

Growth delay in postburn pediatric patients.

Dampened height and weight velocities have been observed in our postburn pediatric population. To validate this phenomenon, the medical records of 80 patients who had sustained a greater than 40% total body surface area burn, were older than 2 years of age at the time of the burn, and were at least 1 year post burn were reviewed. All patients were treated with early excision of the burn wound within 72 hours of injury and received standard post burn resuscitational and nutritional support. Admission height and weight plots were within normal distribution parameters. Yearly growth velocities were calculated for up to 3 years after the burn. Despite adequate nutritional support and maximal exercise and/or long-bone stresses, a profound growth arrest was noted during postburn year 1, which slowly resolved to near normal distribution by postburn year 3. This retrospective study demonstrates that severe thermal injury is associated with a growth delay in the pediatric population. The exact cause of this phenomenon remains unknown.

Acute Disease↗
PubMed1990

Early burn wound excision significantly reduces blood loss.

The hypothesis that near-total early excision of large burns in children can be performed safely with a reduction in blood loss was tested. Of 1662 acutely burned patients admitted to this institution between 1982 and 1989, 594 underwent near-total excision of cutaneous flame or scald burn injuries in a single procedure. Operations took less than 3 hours and there were no operative deaths. Blood losses in burns of more than 30% total body surface area (TBSA) were significantly less at 0.40 +/- 0.06 mL/cm2 and 0.49 +/- 0.49 mL/cm2 excised when surgery was performed within the first 24 hours or after the 16th day after burn, respectively, when compared to 0.75 +/- 0.02 mL/cm2 for those excised between 2 and 16 days after burn (p less than 0.05). Blood loss for burns of less than 30% TBSA was of 1.19 +/- 0.13 mL/cm2. Early excision did not increase mortality rate when compared to later excision times. We suggest that near-total excision of large burns within the first 24 hours reduces blood requirements and morbidity without adversely altering hemodynamic stability or increasing mortality risks.

Blood Transfusion↗
PubMed1990

Effects of recombinant human growth hormone on donor-site healing in severely burned children.

The beneficial effects of growth hormone on wound healing in severely burned children were studied. Forty patients who were 2 to 18 years old, with 40% or more total body surface area (TBSA) and 20% or more TBSA full-thickness flame or scald burns, were randomized in a double-blind study to receive placebo or 0.1 mg/kg/day recombinant human growth hormone (rHGH) until the first donor site healed or to receive 0.2 mg/kg/day rHGH or placebo from admission throughout hospitalization. Patients receiving 0.2 mg/kg/day rHGH demonstrated significantly higher serum IGF-1 levels at 4.8 +/- 1.7 U/mL compared to placebos at 1.6 +/- 0.4 U/mL (p less than 0.05) and a significant decrease in donor-site healing times compared to placebo (p less than 0.05). Length of hospital stay (LOS/%TBSA) was decreased from 0.80 +/- 0.10 days/%TBSA burned in the placebo group to 0.54 +/- 0.04 days/%TBSA burned in the 0.2 mg/kg/day treatment group (p less than 0.05). This translates, for the average 60% TBSA burned patient, to a decrease in LOS from 46 to 32 days.

Adolescent↗
PubMed1990

The scalp as a donor site: revisited.

The scalp cannot be used as skin graft donor site with impunity. A review of 2,620 charts identified 194 pediatric patients whose scalps served as donor sites for split-thickness skin grafts for the treatment of acute burns. The overall incidence of alopecia was 32%. However, the incidence of alopecia in unburned scalps was 13%. The occurrence of alopecia in this group was associated with larger burn area requiring more frequent use of the scalp and shorter intervals between graft harvests (p less than 0.05). Among this group of patients (n = 15), nine had mild spotty alopecia, four had surgically correctable alopecia, and two had global patchy alopecia not amenable to surgical correction. In the patients with concomitant burns to their scalps, the incidence of alopecia was 61%. Whether the burn or the graft harvest caused alopecia could not be established. Meticulous donor site care is mandatory in this latter group when the scalp donor site is indicated.

Adolescent↗
PubMed1989

Managing smoke inhalation injuries.

Inhalation injuries most often occur with cutaneous burns, and the likelihood of an inhalation injury increases incrementally with age of the patient and size of the burn. Damage to the pulmonary parenchymal tissue manifests as increased capillary permeability leading to excessive lung fluid formation and increasing hypoxia. An inhalation injury may be diagnosed using observation of indirect criteria in conjunction with fiberoptic bronchoscopy, xenon 133 radiospirometry, and/or measurement of extravascular lung water. Initially, carbon monoxide poisoning threatens the patient's oxygenation capacity. High-flow oxygen therapy reduces the half-life of carbon monoxide to an acceptable period. The patient proceeds through three stages: pulmonary insufficiency, pulmonary edema, and bronchopneumonia. Treatment is directed toward supporting oxygenation using endotracheal intubation with mechanical ventilation, humidification of inspired air, early mobilization, chest physiotherapy, antibiotics for documented infection, and adequate systemic hydration.

Bronchopneumonia↗
PubMed1989

A comparison of conservative versus early excision. Therapies in severely burned patients.

Early excision and grafting of small burn wounds is a generally accepted treatment. Early excision of burn injuries greater than 30% total body surface area (TBSA) in adults, however, has not been universally accepted. In this study, 85 patients whose ages ranged from 17 to 55 years with greater than 30% total body surface area (TBSA) burns were randomly assigned to either early excision or topical antimicrobial therapy and skin grafting after spontaneous eschar separation. Mortality from burns without inhalation injury was significantly decreased by early excision from 45% to 9% in patients who were 17 to 30 years of age (p less than 0.025). No differences in mortality could be demonstrated between therapies in adult patients older than 30 years of age or with a concomitant inhalation injury. Children (n = 259) with similar large burns treated by early excision showed a significant increase in mortality with increasing burn size and with concomitant inhalation injury (p less than 0.05). The mean length of hospital stay of survivors was less than one day per per cent of TBSA burn in both children and adults.

Adolescent↗
PubMed1989

Longitudinal assessment of breast development in adolescent female patients with burns involving the nipple-areolar complex.

Long-term follow-up of breast development in adolescent female patients with burns of the anterior chest wall is poorly documented. Between 1971 and 1976, 28 female patients with photographic documentation of burns to the anterior chest wall involving the nipple-areolar complex were reviewed. All patients were followed at least until their early teens. The mean age at the time of thermal injury was 5.9 +/- 2.5 years, with a mean follow-up time of 8.9 +/- 2.6 years. Thirteen patients (46 percent) were admitted to the Shriners Burns Institute in Galveston for acute care of their burns. Fifteen patients (54 percent) were referred for long-term follow-up or specific reconstructive procedures following care of the acute burns. In spite of significant thermal injury to the anterior chest wall with involvement of the nipple-areolar complex, no patient failed to develop breasts. Twenty patients (71 percent) required releases of the anterior chest wall to assist breast development. All anterior chest wall releases were accomplished with the use of skin grafts or local skin flaps.

Adolescent↗