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1.
An innovated elastic compression hemostasis technique for extremity excision in patients with extensive burns: A prospective clinical randomized controlled trial
Shen C, Liu X, Zhang B, Cai J, Sun T, Li D, Deng H, Yuan H
Surgery. 2023
Abstract
OBJECTIVE To introduce an innovative elastic compression hemostasis technique for extremity excision in extensively burnt patients and investigate its effectiveness. METHODS Ten patients were included and divided into 2 groups: the control group (4 patients, 12 extremities) receiving the conventional hemostasis technique and the experimental group (6 patients, 14 extremities) receiving the innovative technique. General data of the patients were collected, excision size measured, hemostasis time recorded, average blood loss per 1% total body surface area of the excised wound calculated, incidence of subcutaneous hematoma and take rate determined. RESULTS The 2 groups had no statistical difference in the baseline data. Average blood loss per 1% total body surface area of the excised wound in the upper and the lower extremities was (62.1 ± 11.5) mL and (35.6 ± 11.0) mL in the experimental group, significantly less than (94.3 ± 6.9) mL and (82.3 ± 6.2) mL in the control group; a reduction of 34.1% and 56.8% respectively. Hemostasis time in the upper and the lower extremities were (5.0 ± 0.7) min/1% total body surface area and (2.6 ± 0.3) min/1% total body surface area, respectively, in the experimental group, significantly less than (7.4 ± 0.6) min/1% total body surface area and (4.0 ± 0.9) min/1% total body surface area in the control group; a reduction of 31.8% and 34.9% respectively. The incidences of subcutaneous hematoma were 7.1% and 8.3%, and the take rate (85.9 ± 6.0)% and (86.5 ± 4.8)% in the experimental and the control group, respectively, with no statistically significant differences. CONCLUSION The innovative elastic compression hemostasis technique is a reliable new method that significantly reduces blood loss during extremity excision in patients with extensive burns and is worth wider understanding and application.
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2.
Effect of single dose intravenous tranexamic acid on blood loss in tangential excision of burn wounds - A double blind randomised controlled trial
K, S. A., Kumar, P., Subair, M., Sharma, R. K.
Burns : Journal of the International Society for Burn Injuries. 2022;48(6):1311-1318
Abstract
INTRODUCTION This study was carried out to evaluate role of intravenous tranexamic acid (TXA) in reducing blood loss during tangential excision of burns. METHODS This was a single center, prospective double-blinded parallel arm superiority randomized placebo-controlled trial. Patients (15-55 years) with deep dermal thermal burns <30% undergoing tangential excision were randomly assigned (1:1) to TXA and placebo groups. Patients in TXA and placebo groups received injection TXA 15 mg/kg and 10 ml saline respectively, 10 min preoperatively. Primary outcome was volume of blood loss per square centimeter area of burn excised. Secondary outcomes were total volume of blood loss, postoperative hemoglobin, intraoperative fluid requirement, blood transfusion, graft take and length of hospitalization (LOH). RESULTS Thirty patients were included. Both groups were comparable in terms of Body Mass Index (BMI) preoperative hemoglobin, area of burn excised, duration of surgery and the intraoperative temperature. The average blood loss per square centimeter burn area excised was found to be significantly lower in TXA when compared to placebo group (mean difference: 0.28 ± 0.025 ml/cm(2); p = 0.000). The total volume of blood loss was lower in TXA group (258.7 ± 124.10 ml vs 388.1 ± 173.9 ml; p = 0.07). None of the patients required transfusion. The requirement of intra-operative fluids was similar between the two groups (crystalloids: p = 0.236; colloids: p = 0.238). Postoperative hemoglobin, length of hospitalization and graft-take were comparable between the two groups. CONCLUSION TXA reduced blood loss per unit burn area of tangential excision in <30%TBSA burn, however, we found no significant effect on postoperative Hb and transfusion.
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3.
EHTIC study: evaluation of a new hemostatic agent based on tissue factor in skin grafting procedures
Rojas S, Perez Del Caz MD, Esteban Vico JR, Villaverde E, Llinas A, Martinez JR, Brage C, Valero J, Gonzalez Rodriguez A, Garcia Barreiro J, et al
Burns : Journal of the International Society for Burn Injuries. 2017;43((4):):780-788
Abstract
BACKGROUND Excessive bleeding is a major concern in scar debridement and grafting procedures. TT-173 is a new topical hemostatic agent based on recombinant human tissue factor that has shown promising results in patients who underwent tooth extraction. EHTIC study sought to evaluate the efficacy and safety of TT-173 to reduce the bleeding in donor sites of skin grafting procedures. METHODS EHTIC study was a phase II, randomized, parallel, double blind, placebo controlled trial. Patients received TT-173 (n=38) or placebo (n=33) sprayed over donor site after graft harvest. Time to hemostasis and incidence of adverse events were recorded. Systemic absorption of the product and its immunogenicity were also measured during the follow up of the subjects. RESULTS Treatment with TT-173 significantly reduced the bleeding time from 7 to 3min (Log-Rank p<0.0001). Moreover, bleeding stopped within the 10min of evaluation period in all the patients that received TT-173. In contrast, 24.24% of patients from placebo group required additional measures to arrest hemorrhage (Fisher p=0.0013). Product related adverse events, systemic absorption into blood stream, interferences with the healing of the donor site or immunogenic reaction against TT-173 were not observed. CONCLUSION The new hemostatic agent TT-173 has proven efficacious and safe to reduce the bleeding from donor site. This study paves the way for further investigation of the product as topical hemostatic treatment in plastic surgery and other surgical indications.
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4.
Controlling intraoperative hemorrhage during burn surgery: a prospective, randomized trial comparing NuStat(R) hemostatic dressing to the historic standard of care
Butts CC, Bose K, Frotan MA, Hodge J, Gulati S
Burns : Journal of the International Society for Burn Injuries. 2016;43((2):):374-378
Abstract
INTRODUCTION One of the primary intraoperative challenges during burn surgery is to adequately excise the burn while avoiding massive hemorrhage. This has become increasingly important, as we see more burn patients that are older and with more medical comorbidities. While adequate excision down to healthy tissues for deep burns is essential for skin graft to take, it also leads to active bleeding that can be a challenge to control. Good hemostasis is imperative as a hematoma is the most common cause of graft loss. Several new products have become available to help control intraoperative hemorrhage. A new hemostatic dressing, NuStat(R), is available and approved by FDA in United States. METHODS A single institution prospective randomized control trial was completed at Regional Burn Center of the University of South Alabama comparing NuStat(R) with the institutional historic standard of care. Twenty such patients were included in our study. A cost analysis was also completed as part of the study retrospectively. RESULTS For dressings used to treat the burn site, blood loss on the side treated with NuStat(R) was on average less (27g/100cm2) than the side treated with our historic standard of care (31g/100cm2), though it was not statistically significant (p=0.81). Similarly, on the donor site, blood loss on the side treated with NuStat(R) was on average less (14g/100cm2) than the side treated with our historic standard of care (15g/100cm2), but it was also not statistically significant (p=0.92). Average total blood loss from both excision and donor sites was also less with NuStat(R) (10g/100cm2) compared to the historic standard of care (12g/100cm2), but it was also not significant (p=0.77). There was no difference in the number of cycles required to achieve hemostasis for either the burn (1.15 NuStat(R) vs. 1.1 for historic standard of care, p=0.70) or the donor site (1 vs. 1, p=1.0). When comparing the cost of NuStat(R) versus the historic standard of care, the actual costs incurred for the wounds was less for the portion treated with NuStat(R) ($148.43) when compared to the historic standard of care ($186.45) (p<0.001). CONCLUSIONS Based on these findings, NuStat(R) hemostatic action should be comparable to the historic standard of care, and these newer hemostatic agents evaluated further in burn surgery and bleeding during other procedures such as trauma surgery.
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5.
Efficacy and safety of a fibrin sealant for adherence of autologous skin grafts to burn wounds: results of a phase 3 clinical study
Foster K, Greenhalgh D, Gamelli RL, Mozingo D, Gibran N, Neumeister M, Abrams SZ, Hantak E, Grubbs L, Ploder B, et al
Journal of Burn Care & Research : Official Publication of the American Burn Association. 2008;29((2):):293-303.
Abstract
The objective of this phase 3, multicentered, prospective, randomized, evaluator-blinded, clinical study was to compare skin graft adherence utilizing a fibrin sealant containing 4 IU/ml thrombin (FS 4IU VH S/D [FS 4IU VH S/D will be marketed under the trade name ARTISS upon licensure in the United States]) to graft adherence utilizing staples in burn patients requiring wound excision and skin grafting. FS 4IU VH S/D was compared with staples in 138 patients. Patients had burn wounds measuring < or =40% of total body surface area with two comparable test sites measuring between 1 and 4% total body surface area each. Wound closure at day 28 was assessed using test site planimetry and review of day 28 photographs by three independent blinded evaluators (primary endpoint analysis). Secondary efficacy measures included hematoma/seroma on day 1, engraftment on day 5, and wound closure on day 14. Investigator and patient-reported outcomes were also assessed. The proportion of test sites with complete wound closure at day 28 was 70. 3% in FS 4IU VH S/D treated sites and 65. 8% in stapled sites, as assessed by planimetry. Blinded review of day 28 photographs confirmed that the rate of complete wound closure was similar between the two treatments, although the overall assessed rates of closure were lower than those determined by planimetry: FS 4IU VH S/D (43. 3%) and staples (37. 0%). The lower limit of the 97. 5% confidence interval of the difference between FS 4IU VH S/D and staples was -0. 029, which is above the predefined noninferiority margin of -0. 1. Therefore, FS 4IU VH S/D is at least as efficacious as staples at the 97. 5% one-sided level for complete wound closure by day 28. Hematoma/seroma on day 1 occurred at significantly (P < . 0001) fewer FS 4IU VH S/D-treated sites (29. 7% [95% CI 22. 2-38. 1%]) compared with stapled sites (62. 3% [95% CI 53. 7-70. 4%]). Engraftment on day 5 was deemed to be 100% in 62. 3% (95% CI 53. 7-70. 4%) of the FS 4IU VH S/D-treated sites and 55. 1% (95% CI 46. 4-63. 5%) of the stapled sites (P = . 0890). Complete wound closure by day 14 occurred in 48. 8% (95% CI 39. 9-57. 8%) of the FS 4IU VH S/D treated sites and 42. 6% (95% CI 34. 0-51. 6%) of the stapled sites (P = . 2299). FS 4IU VH S/D scored significantly better than staples for all investigator-assessed outcomes, namely quality of graft adherence (P < . 0001), preference for method of fixation (P < . 0001), satisfaction with graft fixation (P < . 0001), and overall quality of healing (P < . 0001). Likewise, FS 4IU VH S/D scored significantly better than staples for all patient-assessed outcomes, namely anxiety about pain (P < . 0001) and treatment preference (P <. 0001). The safety profile of FS 4IU VH S/D was excellent as indicated by the lack of any related serious adverse experiences. These findings demonstrate that FS 4IU VH S/D is safe and effective for attachment of skin grafts, with outcomes at least as good as or better than staple fixation.
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6.
Recombinant Factor VIIa decreases perioperative blood transfusion requirement in burn patients undergoing excision and skin grafting--results of a single centre pilot study
Johansson PI, Eriksen K, Nielsen SL, Rojkjaer R, Alsbjorn B
Burns. 2007;33((4):):435-40.
Abstract
BACKGROUND Excision of burn wounds is frequently associated with a large volume of blood loss requiring allogeneic blood transfusion. We conducted a pilot study to investigate the effect of activated recombinant coagulation factor VII (rFVIIa) on the reduction of blood transfusion requirements in burn patients undergoing excision and skin grafting. METHODS Eighteen consecutive patients scheduled for the surgery were randomised to receive either placebo or 40 microg/kg rFVIIa administered at first skin incision, and a second dose (40 microg/kg) at 90 min later. Blood transfusion requirements during, and up to 24h post-surgery per patient and percentage full thickness wound excised were compared. In addition, postoperative complications commonly seen in patients with burns as well as adverse events related to rFVIIa were monitored. RESULTS rFVIIa significantly decreased the total number of units of blood components transfused per patient and percentage full thickness burn wound excised compared with placebo (0. 9 versus 2. 2, p=0. 0013) including significant fewer red blood cell units (0. 5 versus 1. 1, p=0. 004). We further observed a trend towards improved graft survival (p=0. 1) and a reduction in multiple organ failures (p=0. 08) in the rFVIIa-treated group. There were no adverse events, in particular thromboembolic events. CONCLUSION rFVIIa might be useful in decreasing blood transfusion requirements in burn patients undergoing excision and skin grafting.
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7.
Comparison of fibrin sealant and staples for attaching split-thickness autologous sheet grafts in patients with deep partial- or full-thickness burn wounds: a phase 1/2 clinical study
Gibran N, Luterman A, Herndon D, Lozano D, Greenhalgh DG, Grubbs L, Schofield N, Hantak E, Callahan JD, Schiestl N, et al
Journal of Burn Care & Research : Official Publication of the American Burn Association. 2007;28((3):):401-8.
Abstract
We undertook a multicenter, randomized, controlled, phase 1/2 clinical study to investigate the safety and efficacy of a fibrin sealant containing 4 IU/ml thrombin (FS 4IU) for the attachment of autologous sheet grafts in patients with deep partial-thickness or full-thickness burn wounds. Fibrin sealant (FS 4IU) was compared with staples for adherence of sheet grafts in 40 patients. Patients had to have burn wounds measuring 40% TBSA or less with two comparable test sites measuring between 1% and 4% TBSA each. Wound beds were prepared before treatment assignment, which was randomized. Percent area of hematoma/seroma at Day 1 (P = . 0138) and questionable viability at Day 5 (P = . 0182) were significantly less for FS 4IU-treated sites. Median percent area of graft survival on Day 14 was 100% for both treatments (P = . 3525). The percentage of completely closed sites generally was greater for FS 4IU-sites on Days 5 to 91; the maximum difference occurred at Day 28 (79. 5% vs 59%; P = . 0215). The safety profile of FS 4IU was excellent as indicated by the lack of any related serious adverse experiences. These findings indicate that FS 4IU is safe and effective for fixation of skin grafts, with outcomes similar to or better than staple fixation. The data suggest that FS 4IU is a promising candidate for further clinical studies focusing on skin graft adhesion and burn wound healing.
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8.
A prospective double blind randomized study comparing the need for blood transfusion with terlipressin or a placebo during early excision and grafting of burns
Mzezewa S, Jönsson K, Aberg M, Sjöberg T, Salemark L
Burns. 2004;30((3):):236-40.
Abstract
INTRODUCTION Early excision and skin grafting has become the standard of good burn management, but it is associated with major blood loss. AIM: To determine the haemostatic effect of terlipressin compared with placebo. MATERIAL AND METHODS Fifty-one patients with burns of 10-20% total body surface area had early excision and split skin grafting of deep burns. The surface area of the burn wound and of the healed graft were measured by planimetry. The patients were randomly allocated to medication, either terlipressin or placebo. Blood loss and number of transfused units of blood were recorded. RESULTS Twenty-one patients received terlipressin, 13 received terlipressin late (cross-over) and 17 received placebo. Six out of 21 patients exposed to terlipressin were transfused with eleven units of packed red blood cells. Seven out of 13 patients crossed over from placebo to terlipressin (late terlipressin) were transfused with 17 units of blood. Eight out of 17 patients exposed to the placebo were transfused with 22 units of blood (P < 0. 05). Graft healing was 1055 +/- 609 cm2 out of 1452 +/- 11 cm2 in terlipressin and 914 +/- 633 cm2 out of 1288 +/- 720 cm2 in the placebo group (n.s.). CONCLUSION Terlipressin reduced the need for blood transfusion by a factor of 2. 5 compared to a placebo without impairment of graft healing.
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9.
A multicenter clinical trial to evaluate the topical hemostatic efficacy of fibrin sealant in burn patients
Nervi C, Gamelli RL, Greenhalgh DG, Luterman A, Hansbrough JF, Achauer BM, Gomperts ED, Lee M, Navalta L, Cruciani TR
Journal of Burn Care & Rehabilitation. 2001;22((2):):99-103.
Abstract
Current surgical management of deep partial-thickness and full-thickness burn wounds involves early excision and grafting. Blood loss during these procedures can be profound, thus prompting the use of topical hemostatic agents to control and minimize hemorrhage during grafting. The primary endpoint of this multicenter trial was to evaluate the efficacy of fibrin sealant as a topical hemostatic agent during skin grafting. The secondary endpoint was to obtain data to support the existing safety profile of a human fibrin sealant (FS) in participating patients as indicated by the type, severity, and frequency of any adverse events within the 24-hour postoperative period. A multicenter prospective, open label, Phase III multicenter, randomized, comparative clinical trial evaluated the use of fibrin sealant in burn patients undergoing skin graft procedures. Each patient served as his or her own control in this randomized, unblinded study of the effect on time to hemostasis in donor sites treated with the investigational FS product. At operation, 1 contiguous donor skin harvest site was bisected into 2 equal halves, 1 of which was then randomly selected and treated with fibrin sealant. At the end of the fibrin sealant application, the time to hemostasis in each of the donor site halves was identified by the operating surgeon and recorded by the research coordinator. The use of any other topical hemostatic agents was prohibited. A significant difference (P < .001) was demonstrated in the mean time to hemostasis between the fibrin sealant treated donor sites when compared painwise to the control sites. The significant difference was consistent across the 6 participating study centers. There were no adverse events associated with the use of fibrin sealant. The investigational FS product was shown to be efficacious, because it significantly decreases the time to hemostasis at the donor skin harvest site in patients undergoing skin grafting and was noted not to cause any adverse reactions.
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10.
Multicenter trial to evaluate the safety and potential efficacy of pooled human fibrin sealant for the treatment of burn wounds
Greenhalgh DG, Gamelli RL, Lee M, Delavari M, Lynch JB, Hansbrough JF, Achauer BM, Miller SF, MacPhee M, Bray GL
Journal of Trauma-Injury Infection & Critical Care. 1999;46((3):):433-40.
Abstract
OBJECTIVE The primary purpose of this multicenter study was to evaluate the safety and potential efficacy of a solvent/detergent-treated commercial fibrin sealant (human) for topical hemostasis in skin grafting. METHODS The study involved a prospective evaluation of changes in viral titers in patients with burns less than 15% after treatment with fibrin sealant (human). Each patient served as his/her own control for an unblinded, randomized comparison of donor site hemostasis and healing. Preoperative serum was obtained to screen for viral titers. At autografting, the recipient site and one of two randomly chosen donor sites were treated with fibrin sealant (human). The use of other hemostatic agents, including epinephrine was prohibited. Each donor site was covered with gauze to collect blood for estimation of the relative amount of bleeding. The healing of the graft and donor sites was observed. Viral titers and wounds were checked monthly for 6 months, and at 9 and 12 months postoperatively. RESULTS Viral titers for human immunodeficiency virus; hepatitis A, B, and C; Epstein-Barr virus; and cytomegalovirus were obtained before and after treatment. Of 47 patients, 34 completed the full year of observation. After treatment, there were no seroconversions to any of the aforementioned viruses. Bleeding at the recipient site appeared well controlled with fibrin sealant (human). Although investigators felt that fibrin sealant (human) improved donor site hemostasis, differences in hemoglobin measurements of blood-soaked dressings failed to reach significance. No differences were noted with regard to acceleration of donor site healing, graft take, or scar maturation at the two groups of donor sites. Anecdotally, the maturation of the recipient site appeared to be accelerated. CONCLUSION Fibrin sealant (human) is safe for use during excision and grafting, and its topical hemostatic potential needs to be examined in patients with larger burns. Its role in scar maturation also needs to be investigated.