A randomized prospective trial of hyperbaric oxygen in a referral burn center population. Recombinant FVIIa decreases perioperative blood transfusion requirement in burn patients undergoing excision and skin grafting--results of a single centre pilot study. Double-blind randomized phase II study of hyperbaric oxygen in patients with radiation-induced brachial plexopathy. Randomized trial comparing cryopreserved cultured epidermal allografts with hydrocolloid dressings in healing chronic venous ulcers. Hyperbaric oxygen therapy in the management of crush injuries: a randomized double-blind placebo-controlled clinical trial. Comparative study of leg wound skin closure in coronary artery bypass graft operations. A pilot study of the effects of Vivostat patient-derived fibrin sealant in reducing blood loss in primary hip arthroplasty. The effect of postoperative wound drainage reinfusion in reducing the need for blood transfusions in elective total joint arthroplasty: a prospective, randomized study. Treatment of diabetic foot ulcers: a comparative study of extracorporeal shockwave therapy and hyperbaric oxygen therapy.
Various studies of the effect of hyperbaric oxygen (HBO) in a wide variety of disease entities have been carried out. In the treatment of burns, animal and human studies have yielded somewhat contradictory results. Controlled studies in humans are limited. A randomized study on the effect of HBO was conducted involving 125 burn patients admitted within 24 hours of injury who were matched by age, burn size, and presence or absence of inhalation injury. Patients in the treatment arm received oxygen at two atmospheres of pressure for 90 minutes twice a day for a minimum of 10 treatments and a maximum of one treatment per total body surface per cent burn. The control group was treated in a similar fashion, except for the absence of HBO. There were no statistically significant differences between the two groups for the outcome measures of mortality, number of operations, and length of stay for the survivors. In this large clinical trial, we were unable to demonstrate any significant benefit to burn patients from the use of HBO. 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.
                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.
                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.
                rFVIIa might be useful in decreasing blood transfusion requirements in burn patients undergoing excision and skin grafting. Radiation-induced brachial plexopathy (RIBP) is an untreatable complication of curative radiotherapy for early breast cancer, characterized by chronic neuropathic pain and limb paralysis. Hyperbaric oxygen (HBO2) therapy is known to promote healing of tissue rendered ischaemic by radiotherapy, but is untested in RIBP.
                Thirty four eligible research volunteers suffering from RIBP were randomized to HBO2 or control group. The HBO2 group breathed 100% oxygen for 100 min in a multiplace hyperbaric chamber on 30 occasions over a period of 6 weeks. The control group accompanied the HBO2 group and breathed a gas mixture equivalent to breathing 100% oxygen at surface pressure. All volunteers and investigators, except the operators of the hyperbaric chamber and the trial statistician, were blind to treatment assignments. The warm sensory threshold, which measures the function of small sensory fibres, was selected as the primary endpoint.
                Pre-treatment neurophysiological tests were grossly abnormal in the affected hand compared to the unaffected hand in both HBO2 and control groups, as expected, but no statistically significant differences were noted in either group at any time up to 12 months post-treatment. However, normalization of the warm sensory threshold in two of the HBO2 group was reliably recorded. Two cases with marked chronic arm lymphoedema reported major and persistent improvements in arm volume for at least 12 months after treatment with HBO2. IINTERPRETATION: There is no reliable evidence to support the hypothesis that HBO2 therapy slows or reverses RIBP in a substantial proportion of affected individuals, although improvements in warm sensory threshold offer some suggestion of therapeutic effect. Improvement in long-standing arm lymphoedema was not anticipated, and justifies further investigation. Cultured epidermal allografts have been successfully used to treat a variety of wounds. Their postulated mechanism of action is through release of cytokines that stimulate epithelialization. On the basis of previous experience we expected ulcers treated with cryopreserved cultured allografts (CCAs) to be healed by 6 weeks. Hydrocolloid dressings (HCDs) have also been reported to be effective in the treatment of venous ulcers.
                Our purpose was to compare the effectiveness of CCAs with HCDs in healing chronic venous ulcers.
                Forty-three patients with 47 ulcers were enrolled in a randomized controlled trial. Ulcers not healed by 6 weeks were changed to the other treatment.
                No difference in the number of healed ulcers between the two groups was observed at 6 weeks. Healing rate, percent reduction of initial ulcer size, and radial progression toward wound closure were significantly greater for CCAs than for HCDs. Pain relief was not significantly different.
                CCAs achieve more rapid healing and greater reduction in ulcer size than HCDs. Hyperbaric Oxygen (HBO) therapy is advocated for the treatment of severe trauma of the limbs in association with surgery because of its effects on peripheral oxygen transport, muscular ischemic necrosis, compartment syndrome, and infection prevention. However, no controlled human trial had been performed until now to specify the role of HBO in the management of crush injuries. Thirty-six patients with crush injuries were assigned in a blinded randomized fashion, within 24 hours after surgery, to treatment with HBO (session of 100% O2 at 2.5 atmosphere absolute (ata) for 90 minutes, twice daily, over 6 days) or placebo (session of 21% O2 at 1.1 ata for 90 minutes, twice daily, over 6 days). All the patients received the same standard therapies (anticoagulant, antibiotics, wound dressings). Transcutaneous oxygen pressure (PtCO2) measurements were done before (patient breathing normal air) and during treatment (HBO or placebo) at the first, fourth, eighth, and twelfth sessions. The two groups (HBO group, n = 18; placebo group, n = 18) were similar in terms of age; risk factors; number, type or location of vascular injuries, neurologic injuries, or fractures; and type, location, or timing of surgical procedures. Complete healing was obtained for 17 patients in the HBO group vs. 10 patients in the placebo group (p < 0.01). New surgical procedures (such as skin flaps and grafts, vascular surgery, or even amputation) were performed on one patient in the HBO group vs. six patients in the placebo group (p < 0.05). Analysis of groups of patients matched for age and severity of injury showed that in the subgroup of patients older than 40 with grade III soft-tissue injury, wound healing was obtained for seven patients (87.5%) in the HBO group vs. three patients (30%) in the placebo group (p < 0.05). No significant differences were found in the length of hospital stay and number of wound dressings between groups. For the patients with complete healing, the PtCO2 values of the traumatized limb, measured in normal air, rose significantly between the first and the twelfth sessions (p < 0.001). No significant change in PtCO2 value was found for the patients whose healing failed. The Bilateral Perfusion Index (BPI = PtCO2 of the injured limb/PtCO2 of the uninjured limb) at the first session increased significantly from 1 ata air to 2.5 ata O2 (p < 0.05). In patients with complete healing, the BPI was constantly greater than 0.9 to 2.5 ata O2 during the following sessions, whereas the BPI in air progressively rose between the first and the twelfth sessions (p < 0.05), reaching normal values at the end of the treatment. In conclusion, this study shows the effectiveness of HBO in improving wound healing and reducing repetitive surgery. We believe that HBO is a useful adjunct in the management of severe (grade III) crush injuries of the limbs in patients more than 40 years old. A prospective randomised study of four different methods of leg wound skin closure after removal of the long saphenous vein was carried out in 113 patients undergoing coronary artery bypass grafting. These methods were: (1) continuous nylon vertical mattress suture (27 patients); (2) continuous subcuticular absorbable (Dexon) suture (29 patients); (3) metal skin staples (Autosuture) (27 patients); and (4) adhesive sutureless skin closure ("Op-site") (30 patients). All wounds were examined by two independent observers at five, 10, and 45 days after operation. At five days, inflammation, extent of oedema, discharge, and infection were assessed. At 10 days attention was paid to the state of wound healing and at 45 days to the final cosmetic appearance. The use of continuous subcuticular suture resulted in significantly less discharge than did the use of metal staples, nylon vertical mattress suture, or Op-site. The incidence of established wound infection was 4.5% overall, with no infection in the wounds closed with Dexon. Assessment of the healing process showed subcuticular Dexon to be more effective than metal staples or vertical mattress nylon suture. The final cosmetic result showed continuous subcuticular suture to be superior to nylon vertical mattress suture and skin staples but as effective as Op-site sutureless skin closure. A pilot study evaluated the effectiveness of Vivostat patient-derived fibrin sealant in reducing blood loss in patients who underwent primary hip arthroplasty. Eighty adult patients undergoing elective surgery were randomized to receive either Vivostat sealant or control (no additional hemostatic treatment). Patients allocated Vivostat sealant donated 120 mL of blood, which was then processed perioperatively to produce a fibrin sealant that was applied to the bleeding wound surfaces just before closure. Transfusion requirements, blood loss during surgery, drain volumes, and daily hematocrit and hemoglobin levels were measured. Hospitalization times, adverse events, and postoperative wound complications were also monitored. Blood loss during surgery and wound drainage volume was lower in the Vivostat group than in the control group, although the differences were not significantly different. Transfusion requirements (median, 270 mL of packed red blood cells) and hospitalization times (both median 7 days) were the same for both groups. No adverse events related to the use of Vivostat occurred. There were indications of a possible reduction in the incidence of postoperative wound oozing (15% vs 25%) and hematomas (6% vs 11%) with the use of Vivostat compared with the control group, although differences were not statistically significant. In conclusion, in this pilot study, use of Vivostat patient-derived fibrin in hip arthroplasty was not associated with a significant reduction in blood loss. Further studies, with larger numbers of patients, may be warranted to investigate a possible benefit of Vivostat in reducing postoperative wound complications. A prospective, randomized study was conducted in 24 patients using the Solcotrans Orthopaedic Drainage Reinfusion System (Smith & Nephew Richards Inc, Memphis, Tenn) for postoperative blood salvage in total joint arthroplasty. The amount of postoperative autologous blood salvage averaged 946 mL. Only 25% of the study group required postoperative transfusions, compared to 83% of the control group (P = .016). In total knee arthroplasties, only 11% of the study group required transfusions, compared to 78% of the control group (P = .018). There were no transfusion reactions, infectious complications, or coagulopathies. Postoperative blood salvage is a safe, reliable, and effective source of autologous blood. This study compared the effectiveness of extracorporeal shockwave therapy (ESWT) and hyperbaric oxygen therapy (HBOT) in chronic diabetic foot ulcers.
                The ESWT group (39 patients/44 feet) received shockwave therapy twice per week for total six treatments. The HBOT group (38 patients/40 feet) received hyperbaric oxygen therapy daily for total 20 treatments. Evaluations included clinical assessment, blood flow perfusion scan and histopathological examination.
                The overall clinical results showed completely healed ulcers in 57% and 25% (P = 0.003); ≥ 50% improved ulcers in 32% and 15% (P = 0.071); unchanged ulcers in 11% and 60% (P < 0.001) and none worsened for the ESWT and the HBOT group respectively. The blood flow perfusion rates were comparable between the two groups before treatment (P = 0.245), however, significant differences were noted after treatment favoring the ESWT group (P = 0.002). Histopathological examination revealed considerable increases in cell proliferation and decreases in cell apoptosis in the ESWT group as compared to the HBOT group.
                ESWT is more effective than HBOT in chronic diabetic foot ulcers. ESWT-treated ulcers showed significant improvement in blood flow perfusion rate and cell activity leading to better healing of the ulcers relative to HBOT in chronic diabetic foot ulcers.
                Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.
There is a lack of high quality, valid research evidence regarding the effects of HBOT on wound healing. Whilst two small trials suggested that HBOT may improve the outcomes of skin grafting and trauma these trials were at risk of bias. Further evaluation by means of high quality RCTs is needed.