William L. Hickerson

Multicenter postapproval clinical trial of Integra dermal regeneration template for burn treatment.

The safety and effectiveness of Integra Dermal Regeneration Template was evaluated in a postapproval study involving 216 burn injury patients who were treated at 13 burn care facilities in the United States. The mean total body surface area burned was 36.5% (range, 1-95%). Integra was applied to fresh, clean, surgically excised burn wounds. Within 2 to 3 weeks, the dermal layer regenerated, and a thin epidermal autograft was placed. The incidence of invasive infection at Integra-treated sites was 3.1% (95% confidence interval, 2.0-4.5%) and that of superficial infection 13.2% (95% confidence interval, 11.0-15.7%). Mean take rate of Integra was 76.2%; the median take rate was 95%. The mean take rate of epidermal autograft was 87.7%; the median take rate was 98%. This postapproval study further supports the conclusion that Integra is a safe and effective treatment modality in the hands of properly trained clinicians under conditions of routine clinical use at burn centers.

A multicenter clinical trial of a biosynthetic skin replacement, dermagraft-TC, compared with cryopreserved human cadaver skin for temporary coverage of excised burn wounds

This multicenter study compared the use of a biosynthetic human skin substitute with frozen human cadaver allograft for the temporary closure of excised burn wounds. Dermagraft-TC (Advanced Tissue Sciences, Inc.) (DG-TC) consists of a synthetic material onto which human neonatal fibroblasts are cultured. Burn wounds in 66 patients with a mean age of 36 years and a mean burn size of 44% total body surface area (28% total body surface area full-thickness) were surgically excised. Two comparable sites, each approximately 1% total body surface area in size, were randomized to receive either DG-TC or allograft. Both sites were then treated in the same manner. When clinically indicated (> 5 days after application) both skin replacements were removed, and the wound beds were evaluated and prepared for grafting. DG-TC was equivalent or superior to allograft with regard to autograft take at postautograft day 14. DG-TC was also easier to remove, had no epidermal slough, and resulted in less bleeding than did allograft while maintaining an adequate wound bed. Overall satisfaction was better with DG-TC.

Fournier's gangrene : Therapeutic impact of hyperbaric oxygen

&NA; Many controversial issues exist surrounding the disease pathogenesis and optimal management of Founiers gangrene. In Fourniers original descriptions, the disease arose in healthy subjects without an obvious cause. Most contemporary studies, however, are able to identify definite urologic or colorectal etiologies in a majority of cases. To investigate disease presentation, treatment modalities, and overall mortality, a retrospective analysis of Fourniers gangrene from a single institution is presented. Since 1990, 26 cases of Fourniers gangrene have been diagnosed at the University of Tennessee. An evaluation of intercurrent disease revealed that 38 percent of the patients had diabetes mellitus, 35 percent manifested ethanol abuse, and 12 percent were systemically immunosuppressed. Fifteen patients (58 percent) presented with identifiable etiologies for their disease: 31 percent (8) urethral disease or trauma, 19 percent (5) colorectal disease, and 8 percent (2) penile prostheses. Management in all cases involved prompt surgical debridement with initiation of broad‐spectrum antibiotics. Multiple debridements, orchiectomy, urinary diversion, and fecal diversion were performed as clinically indicated. Fourteen patients received hyperbaric oxygen as adjuvant therapy. Statistically significant results were noted with mortality rates of 7 percent in the group receiving hyperbaric oxygen (n = 14) versus 42 percent in the group not receiving hyperbaric oxygen (n = 12). Overall mortality was 23 percent. Controversy still surrounds disease pathogenesis in Fourniers gangrene, particularly in regard to etiology. Our study corroborates current trends in that a clear focus of origin was identified in a majority of the cases. Although a grim prognosis usually accompanies the diagnosis, this study shows significant improvement combining traditional surgical and antibiotic regimens with hyperbaric oxygen therapy. (Plast. Reconstr. Surg. 101: 94, 1998.)

Cultured epidermal autografts and allodermis combination for permanent burn wound coverage

Cultured epidermal autografts (CEA) have been shown to be an effective permanent skin replacement for major burn injuries, but are more sensitive to adverse conditions than split thickness grafts (Clarke et al., 1988). Cuono et al. (1986, 1987) have described the successful use of engrafted allodermis as a wound bed for cultured grafts. We report on a method of preparing allodermis and grafting CEA in five patients with major burns (48-70 per cent TBSA, average 59.6 per cent). The average age was 38.8 years (20-60 years). All full thickness wounds were excised down to fat within 7 days of admission, and covered with meshed split thickness cryopreserved homograft. Over the ensuing 2-3 weeks, the homograft became engrafted. At surgery, the allo-epidermis was removed, leaving the dermal components as a viable bed for the CEA. Keratinocytes derived from a full thickness biopsy were grown to confluence by the method of Rheinwald and Green (1975), and 25 cm2 sheets were stapled to Vaseline gauze backings and applied to freshly excised wounds. Seven to 10 days after surgery, the gauze backings were removed. The average take ranged from 87-100 per cent (average 93.6 per cent). Follow-up for up to 4 years shows supple skin that has been durable, and resistant to trauma and infection.

Regional Variations of Laser Doppler Blood Flow in Ischemic Skin Flaps

An island skin flap was designed on the left inferior epigastric neurovascular bundle of anesthetized male rats. Blood flow was measured in situ with a laser Doppler flowmeter at 20 discrete points on a grid system (5 points in each quadrant of the flap) before and after surgery, or before vascular occlusion, during reperfusion, and 48 to 72 hours later. Two series of experiments were performed. In the first series, the raised flap was placed in a bath containing heated Ringers solution and the left pedicle was cross-clamped. After 30 minutes, adenosine at a concentration that produced supramaximal vasodilatation, or its vehicle, was added to the bath. After 1 hour total occlusion time, the vascular clamp was released and adenosine treatment was continued for the first 30 minutes of reperfusion. In the second series, the protocol was similar except that adenosine, or its vehicle, was infused into the ischemic flap by means of the distal stump of the right inferior epigastric artery. After 48 to 72 hours, fluorescein was injected IV. The data showed a significant regional variation in baseline laser Doppler blood flow that was further altered by surgically raising the flap. Whereas proximal axial laser Doppler blood flow was essentially unchanged from the preoperative baseline, distal axial laser Doppler blood flow decreased 10 to 50 percent, and proximal and distal dependent laser Doppler blood flow decreased 50 to 80 percent. Thus no single value accurately reflected total flap perfusion. Necrosis occurred only in the dependent flap regions, which confirmed previous work. In the dependent regions, especially along the incision line, postoperative laser Doppler blood flow was lowest. Fluorescein penetration at 48 to 72 hours was strongly correlated with laser Doppler blood flow if a correction factor of 2.3 was considered. With adenosine treatment, in contrast to its vehicle, laser Doppler blood flow tended to increase during the postoperative period. We conclude (1) that surgical construction of a skin flap can aggravate a regional variation in perfusion that can be detected with a laser Doppler flowmeter, (2) that continuous monitoring of laser Doppler blood flow at a single site could be misleading unless tissue perfusion is uniform, and (3) that adenosine has a potential beneficial effect in ischemic skin tissue.

A comparison of the mechanical, kinetic, and biochemical properties of fibrin clots formed with two different fibrin sealants.

The objective of the present study was to compare the mechanical, kinetic, and biochemical properties of fibrin clots produced using EVICEL Fibrin Sealant (Human) and TISSEEL Fibrin Sealant. The stiffness/elasticity and strength of fibrin clots formed with EVICEL and TISSEEL were assessed using applied mechanical force and thromboelastography (TEG). The factor XIII content of the fibrin clots was also evaluated. Mean Young modulus and tensile strength of the fibrin clots produced by EVICEL were significantly higher than those of clots produced by TISSEEL (P < 0.05 for both). The mean time to initial clot formation and mean time to the predefined level of clot formation were numerically shorter for EVICEL compared with TISSEEL. Furthermore, mean maximal amplitude of the clots formed with EVICEL was significantly greater than that for the clots formed with TISSEEL. Mean concentration of factor XIII for the EVICEL fibrinogen samples tested was 9 IU/ml compared with undetectable concentrations of factor XIII for the TISSEEL fibrinogen samples. Fibrin clots formed with EVICEL have a much higher resistance to stretching and tensile strength and are more capable of maintaining their structure against applied force than those formed with TISSEEL. EVICEL also allows more rapid development of fibrin clots than TISSEEL. This superior clot strength and resilience obtained with EVICEL relative to TISSEEL may be due in large part to the presence of factor XIII.

Imipenem pharmacokinetics in patients with burns

The pharmacokinetics of imipenem were studied in 11 adult patients with severe burns who were receiving a therapeutic regimen of imipenem‐cilastatin 500 mg intravenously every 6 hours. Serial blood samples for measuring imipenem and 24‐hour urine collections for creatinine clearance (CrCl) were obtained after the initial dose and after multiple dosing. Plasma was assayed for imipenem by use of HPLC. A two‐compartment model provided a superior fit to the data compared with a one‐compartment model in 9 of the 11 patients. There was no significant difference in any pharmacokinetic parameter between the initial dose and after multiple dosing (p > 0.05). Combined mean (±SD) parameter estimates for the two dosing periods were as follows: Vc, 0.11 ± 0.06 L/kg; Vss, 0.22 ± 0.06 L/kg; CL, 12.5 ± 3.6 L/hr/1.73 m2; t½α, 0.18 ± 0.13 hr; t½β, 1.12 ± 0.44 hr. Mean clearance in two patients with creatinine clearance values >150 ml/min/1.73 m2was 17.7 L/hr/1.73 m2. Mean clearance in two patients with creatinine clearance values <50 ml/min/1.73 m2 was 8.5 L/hr/1.73 m2. No pharmacokinetic parameter was significantly different from previously reported parameters in normal volunteers (p > 0.05). Creatinine clearance ranged from 17 to 218 ml/min/1.73 m2. Imipenem clearance was significantly related to creatinine clearance (CL = 63 + 0.059 CLCR; r2 = 0.60, p = 0.0001). No significant association was found between total body surface area burns and imipenem clearance (p > 0.05). Our data suggest imipenem pharmacokinetics in patients with burns are comparable to those in normal volunteers although substantial intersubject variability exists. Measured creatinine clearance values may be useful in estimating imipenem clearance clinically.

A comparison of renal phosphorus regulation in thermally-injured and multiple trauma patients receiving specialized nutrition support

To compare phosphorus intake and renal phosphorus regulation between thermally injured patients and multiple trauma patients, 40 consecutive critically ill patients, 20 with thermal injury and 20 with multiple trauma, who required enteral tube feeding were evaluated. Phosphorus intakes were recorded for 14 days from the initiation of tube feeding which was started 1 to 3 days postinjury. Serum for determination of phosphorus concentrations was collected at days 1, 3, 7, and 14 of the study period. A 24-hour urine collection was obtained during the first and second weeks of nutrition support for urinary phosphorus excretion, fractional excretion of phosphorus, renal threshold phosphate concentration, and phosphorus clearance. Average total daily phosphorus intake during the 14-day study for thermally injured patients and multiple trauma patients was 0.99+/-0.26 mmol/kg/d vs 0.58+/-0.21 mmol/kg/d, respectively, p < .001. Serum phosphorus concentration on the third day of observation was significantly lower in the thermally injured group than those with multiple trauma (1.9+/-0.8 mg/dL vs 3.0+/-0.8 mg/dL, p < or = .01). A trend toward hypophosphatemia in the thermally injured group persisted by the seventh day of feeding (2.7+/-1.2 mg/dL vs 3.3+/-0.6 mg/dL, p < or = .04). Differences in urinary phosphorus excretion was not statistically significant between the thermally injured and multiple trauma groups (271+/-213 mg/d vs 171+/-181 mg/d for week 1, and 320+/-289 mg/d vs 258+/-184 mg/d for week 2, respectively). Urinary phosphorus clearance, fractional excretion of phosphorus, or renal threshold phosphate concentrations were also not significantly different between thermally injured and multiple trauma patients. During nutrition support, serum phosphorus concentrations are lower in thermally injured patients compared with multiple trauma patients despite receiving a significantly greater intake of phosphorus. Renal phosphorus regulation does not significantly contribute to the profound hypophosphatemia observed in thermally injured patients when compared with multiple trauma patients during nutrition support.

Surgical management of the burn wound and use of skin substitutes: an expert panel white paper.

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . e61 Payer Policies: Problems and Solutions . . . . . e61 Medicare . . . . . . . . . . . . . . . . . . . . . . . . . . . .e61 Nongovernment Payers . . . . . . . . . . . . . . . . .e62 Every Burn Patient is Unique . . . . . . . . . . . . e62 Burn Care: A National Resource . . . . . . . . . . e62 Wound Classification: Burns as Acute Wounds . . e62 Burns vs Chronic Wounds . . . . . . . . . . . . . . . e62 Types of Burns . . . . . . . . . . . . . . . . . . . . . . . e63 Burn Depth and Classification . . . . . . . . . . . . e63 Skin Diagram . . . . . . . . . . . . . . . . . . . . . . . . e64 First-Degree (Superficial or Epidermal) Burns . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . e64 Second-Degree (Partial-Thickness) Burns . . . e64 Third-Degree (Full-Thickness) Burns . . . . . . e64 Overview of Daily Evaluation and Management . e64 Burn Wound Care . . . . . . . . . . . . . . . . . . . . . e64 Care of Operated and Nonoperated Wounds . . . e64 Evaluation and Management: Critical Care Services . . . . . . . . . . . . . . . . . . . . . . . . . . . . . e65 Care of Unrelated Conditions . . . . . . . . . . . . e65 Surgical Treatment of Burns . . . . . . . . . . . . . . . e65 Escharotomy . . . . . . . . . . . . . . . . . . . . . . . . . e65 Subsequent Surgical Excision of Burn Wound . . . . . . . . . . . . . . . . . . . . . . . . .e66 Debridement of Burn Wounds . . . . . . . . . . . . e66 Excision of Burn Wounds . . . . . . . . . . . . . . . e66 Singleand Multiple-Stage Excision and Grafting . . . . . . . . . . . . . . . . . . . . . . . . . e66 Single-Stage Excision and Grafting . . . . . . .e66 Multiple-Stage Excision and Grafting . . . . .e68 Case Study: Acute Care of Burn Wounds . . .e69 Burn Wound Coverage . . . . . . . . . . . . . . . . . . . e70 Skin Substitutes and Skin Replacements . . . . . e70 Temporary Wound Coverage . . . . . . . . . . . . . e71 Permanent Wound Coverage . . . . . . . . . . . . . e71 Table of Indications: Integra and Alloderm . . . . . . . . . . . . . . . . . . . . . . . . . . . .e72 Postoperative Daily Evaluation and Management . . . . . . . . . . . . . . . . . . . . . . . . . . . e72 Operated Burn Wounds . . . . . . . . . . . . . . . . . e72 Care of Burn Wounds Unrelated to Previously Operated Wounds . . . . . . . . . . . . . e73 Unrelated Conditions . . . . . . . . . . . . . . . . . . e73 Postdischarge Burn Wound Management . . . . . e73 Discharge and Follow-Up . . . . . . . . . . . . . . . e73 Case Study: Burn Wound Care Postacute Care Discharge . . . . . . . . . . . . . . . . . . . . . . .e74 Conclusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . e75 Appendix 1 . Glossary . . . . . . . . . . . . . . . . . . . . e75 Appendix 2 . Burn Center Referral Criteria . . . . e76 Appendix 3 . James Barrett Brown Paraphrase . . . . . . . . . . . . . . . . . . . . . . . . . . . . e77 Appendix 4 . Correct Coding and Payment for Burn Excision and Grafting Following National Guidelines for CPT Primary and Add-on Secondary Codes . . . . . . . . . . . . . . . . . e77 AMA/CPT Guidelines for Add-on Codes . . . e78 Payer Guidelines with Examples . . . . . . . . . . e78 Case Study: Acute Care of Burns . . . . . . . . . .e79 Example 2: Coding Burn Excision Followed by Application of Acellular Dermal Replacement and Later Grafting of Tissue Cultured Epidermal Autografts (CEA) . . . . . . . . . . . . . . . . . . . . .e79 From the *Department of Surgery, Shriners Hospitals for Children, Cincinnati, Ohio; †University of Cincinnati College of Medicine, Cincinnati; ‡Department of Surgery, University of Arizona College of Medicine, Phoenix; §Department of Surgery, University of Minnesota Medical School, Minneapolis; ‖Department of Plastic Surgery, University of Tennessee Health Science Center, Memphis; ¶Department of Surgery, Wake Forest Baptist Health, Winston-Salem, North Carolina; #Department of Plastic Surgery, University of Kansas Medical Center, Kansas City; **Department of Trauma Surgery Services, Bronson Methodist Hospital, Kalamazoo, Michigan; ††Karen Zupko & Associates, Inc ., Chicago, Illinois; ‡‡Medical Communications Management Group, Albuquerque, New Mexico . . Copyright

Quality burn rehabilitation: cost-effective approach.

As funding for health care becomes a national concern, and workmans compensation and private health insurance companies attempt to limit their expenditures in the treatment of the client with burns, it may become the responsibility of the burn specialists to create a cost-effective approach to quality burn rehabilitation. Our outpatient rehabilitation program has taken a cost-effective approach that limits the use of inpatient rehabilitation, emphasizes the burn team guiding the client to a quick functional return to home and work, and concentrates costs for therapy rather than room and board. This cost-effective rehabilitation approach emphasizes an intensive 6-hours-per day, 5-days-per-week outpatient program that begins immediately after discharge. In a 2 1/2-year follow-up of this cost-effective program, the following were identified. (1) A 40% reduction in costs for third-party payers and (2) clients returning to work an average of 4 months after their injury. In the cost-effective rehabilitation approach, 82% of the health care costs are concentrated for therapy. In the traditional inpatient rehabilitation program, room and board costs comprise 57% of the charges. Because it is the responsibility of the burn specialists to educate the health care payers, a program description to implement the cost-effective approach to burn rehabilitation is provided.