A Prospective Multicenter Randomized Controlled Trial to Evaluate the Efficacy of Chitosan Hydrogel Paste in Comparison to Commercial Hydroactive Gel as a Wound Bed Preparation.

Background This clinical trial aimed to evaluate the clinical efficacy of chitosan derivative hydrogel paste (CDHP) as a wound bed preparation for wounds with cavities. Methods This study enrolled 287 patients, with 143 patients randomized into the CDHP group (treatment) and 144 patients randomized into the commercial hydroactive gel (CHG) group (control). The granulation tissue, necrotic tissue, patient comfort, clinical signs, symptoms, and patient convenience during the application and removal of the dressing were assessed. Results The study was completed by 111 and 105 patients from the treatment and control groups, respectively. Both groups showed an increasing mean percentage of wound granulation over time when the initial wound size and comorbidity were adjusted (F(10,198) = 4.61; p < 0.001), but no significant difference was found between the groups (F(1,207) = 0.043; p = 0.953). The adjusted mean percentage of necrotic tissue of both groups showed a significant decrease over time (F(10,235) = 5.65; p <0.001), but no significant differences were found between the groups (F (1,244) = 0.487; p = 0.486). Conclusion CDHP is equivalent to CHG and is an alternative in wound management and wound bed preparation for wounds with cavities.

Functional outcome and quality of life following treatment for post-traumatic osteomyelitis of long bones.

INTRODUCTION: The clinical outcomes and factors associated with treatment failure of post-traumatic osteomyelitis have been investigated in many studies. However, limb functionality and quality of life following treatment for this condition have not been thoroughly studied. METHODS: This cross-sectional study included 47 patients with post-traumatic osteomyelitis of the lower limb. Functional outcome was assessed using the Lower Extremity Functional Score (LEFS), and quality of life was assessed using the validated Malay version of the Short Form-36 questionnaire version 2. RESULTS: The mean follow-up period was 4.6 (range 2.3-9.5) years, and the median age of the patients was 44 years. Osteomyelitis was located in the tibia for 26 patients and in the femur for 21 patients. Osteomyelitis was consequent to internal infection in 38 patients and due to infected open fractures in nine patients. 42 (89.4%) patients had fracture union and control of infection. Bone defect was found to be a significant contributing factor for treatment failure (p = 0.008). The median LEFS for the success group was 65, compared to 49 for the failure group. Although the success group showed better scores with regard to quality of life, the difference between the two groups was not statistically significant. CONCLUSION: Treatment of post-traumatic osteomyelitis of the lower limb had a high success rate. The presence of a bone defect was associated with treatment failure. Successfully treated patients had significantly better functional outcomes than in those in whom treatment failed.

Predictors of major lower limb amputation among type II diabetic patients admitted for diabetic foot problems.

INTRODUCTION: Diabetes mellitus (DM) is the most common cause of amputations in Malaysia. This study aimed to identify the predictive factors for major lower limb amputation among patients with type 2 DM (T2DM) who were admitted to a hospital, in order to reduce its likelihood. METHODS: This cross-sectional study involved 218 patients with T2DM who were admitted to Hospital Tengku Ampuan Afzan, Kuantan, Malaysia, for diabetic foot problems from June 2011 to July 2012. A form was developed to document the patients' profiles, comorbidities, complications, investigations, treatment and clinical outcomes. The predictors for major lower limb amputations were determined using univariate and stepwise logistic regression analysis. RESULTS: A total of 31 patients underwent major lower limb amputations (25 transtibial, 6 transfemoral). The following factors were found to be associated with the incidence of major lower limb amputations: T2DM duration ≥ 10 years, diabetic neuropathy, diabetic nephropathy, presentation with gangrene, diabetic foot conditions of Wagner grade 4 or 5, and necrotising fasciitis. Patients who underwent major amputations had significantly lower haemoglobin and albumin levels, and higher total white blood cell counts, erythrocyte sedimentation rates, and C-reactive protein, urea and creatinine levels. However, only T2DM duration ≥ 10 years, positive bacterial culture and albumin levels were significant on stepwise logistic regression analysis. CONCLUSION: T2DM duration ≥ 10 years, positive bacterial culture and low albumin levels were found to be significant predictive factors for major lower limb amputation among patients with T2DM admitted for diabetic foot problems.

Factors associated with the outcome of open tibial fractures.

BACKGROUND: Although open tibial fractures are common in Malaysia, the outcomes for these patients have not been evaluated in the literature. This retrospective study was conducted to examine the factors associated with infection and non-union in open tibial fractures managed at Hospital Tengku Ampuan Afzan (HTAA), Kuantan, in 2009. METHODS: From 1 January until 31 December 2009, the Department of Orthopaedics of HTAA managed 58 patients with open tibial fracture who had a minimum of a one year follow-up period. The median age was 24.5 years (range: 4 to 72 years). The open tibial fractures were graded using the Gustilo open fracture classification as follows: 4 grade I, 21 grade II, 24 grade IIIA and 9 grade IIIB. All open fractures were subjected to a standard treatment protocol at HTAA, which includes the use of prophylactic antibiotics, emergency debridement, fracture stabilisation, wound coverage, and bone reconstruction when required. The mean time from injury to the initial debridement was 29.7 hours (range: 13 to 216 hours). RESULTS: Seventeen (29%) cases were complicated by infection, and 10 patients (17%) developed non-union. The grade of the open fracture was significantly associated with infection, and age and the time interval between the injury and the initial wound debridement were significantly associated with non-union. CONCLUSION: The high rates of infection and non-union, particularly in severe open fractures, indicate that there is a need to improve the management of open tibial fractures treated at HTAA. The time to initial debridement is an important factor that can be readily amended to improve the outcome. Further studies with larger sample sizes are likely needed to replicate and confirm our findings.

Outcomes of infected grade IIIB open tibial fractures.

INTRODUCTION: Infection following grade IIIB open tibial fracture is common. The primary aim of managing this condition is to achieve control of infection before the bone reconstruction procedure is performed. The outcomes for such patients have not been evaluated in the literature. This study was conducted to examine the outcome of a multi-stage procedure for the treatment of infected grade IIIB open tibial fractures. METHODS: Between 2004 and 2008, we treated 11 patients with infected grade IIIB open tibial fractures in our unit. The management of infected grade IIIB open tibial fracture comprised three stages, which included serial debridement, wound closure by local flap surgery and bone reconstruction. The margin of resection and the type of bone reconstruction depended on the anatomical location of the disease, the extent of osteomyelitis and patient preference regarding treatment options. Bone reconstruction procedures included bone grafting, plating, interlocking nail, hybrid and monolateral external fixator, and Ilizarov bone transport. RESULTS: Gram-negative organisms were isolated from all patients. Pseudomonas aeruginosa (P. aeruginosa) (44%) was the most common organism cultured. Infection was resolved in all patients. Nine fractures achieved union, with a mean union time of 15 months. Two patients with P. aeruginosa infection developed non-union of the fracture and refused additional surgery after three years of treatment. CONCLUSION: The multi-stage management approach is well-accepted and effective in controlling infection in infected grade IIIB open tibial fractures.

Percutaneous plating in paediatric tibial fractures.

BACKGROUND: Although non-operative treatment is a mainstay of tibial fracture management in children, certain fractures require a surgical approach. However, choices concerning optimal methods and implants are difficult. The purpose of this study was to determine the effectiveness of percutaneous plating of tibial fractures in children. MATERIALS AND METHODS: Sixteen tibial fractures treated using the percutaneous plating technique between 2000 and 2007 were reviewed. The mean age at operation was 10 years 9 months (range: 6-16 years). There were eight open and closed fractures each. Operative indications were acute fractures with associated injuries or fractures, open fractures and compartment syndrome. Nonunions or failures following other treatments were also indicated. Without exposing the fracture sites, the plates were fixed through a subcutaneous tunnel from remote incisions. RESULTS: All fractures healed without a bone graft. The mean time required for union was 13 weeks (range: 8-24 weeks). No major complications such as malunion, implant failure or deep infection occurred. With the exception of one case with a 15-mm overgrowth, no discrepancy in leg length over 10mm was encountered. Other minor complications included one case each of transient superficial infection and skin irritation caused by the plate. All patients achieved an excellent or satisfactory clinical outcome with no limping. SUMMARY: Percutaneous plating technique is a safe alternative treatment for paediatric tibial fractures that are difficult to manage using other methods.

Distal tibial reconstruction with use of a circular external fixator and an intramedullary nail. The combined technique.

BACKGROUND: Distal tibial reconstruction with use of an external fixator when there is bone loss, limb-length discrepancy, and/or ankle instability is associated with many problems. The technique of limb-lengthening, ankle arthrodesis, and segmental transfer over an intramedullary nail has been introduced to overcome these problems. The present study investigates this combined technique. METHODS: Between 2002 and 2005, six patients, who ranged from seventeen to seventy years old, underwent distal tibial reconstruction and ankle arthrodesis with use of a circular external fixator and an intramedullary nail to treat a distal tibial defect following resection for chronic osteomyelitis or tumor or to treat a limb-length discrepancy combined with ankle instability. Functional and radiographic results were evaluated, with use of the criteria described by Paley et al., at an average follow-up of thirty-four months. RESULTS: The mean size of the bone defects in three patients was 5.3 cm (2, 7, and 7 cm), and the mean amount of the limb-shortening in four patients was 5.25 cm (range, 4 to 6 cm). The mean external fixation time was 3.5 months, and the mean external fixator index was 0.57 mo/cm. There was no recurrence of infection in the two patients with osteomyelitis. All six patients had excellent bone results, and the functional results were excellent for two patients and good for four patients. There were four complications, three of which were categorized, according to Paley, as a problem (a difficulty that occurs during lengthening and is resolved without operative intervention) and one that was categorized as an obstacle (a difficulty that occurs during lengthening and needs operative treatment). CONCLUSIONS: The combined technique is an improvement over the classic external fixation techniques of distal tibial reconstruction with ankle arthrodesis. It reduces the duration of external fixation, thus increasing patient acceptance, and it is associated with a low complication rate facilitating more rapid rehabilitation.