Open fractures of the tibia, particularly Gustilo Anderson type III injuries, represent a major therapeutic challenge because of combined soft-tissue damage with high contamination risk and compromised vascularity. These factors together confer a substantial risk of deep infection and increase the chances of post-traumatic osteomyelitis [1]. Preventing osteomyelitis after such injuries is critical: infection prolongs hospitalization, increases morbidity, complicates definitive skeletal reconstruction, and substantially raises health-care costs and the likelihood of amputation [1]. Traditional management principles such as early and thorough debridement, stabilization, timely soft-tissue coverage, and appropriate systemic antibiotics are the basis of treatment. However, despite modern multidisciplinary care, the infection rates for severe open tibial fractures remain unacceptably high [1].  Vacuum-assisted closure (VAC) or Negative pressure wound therapy (NPWT) was proposed in the late 1990s and quickly became popular as a treatment to use alongside complex wounds [2]. The method places controlled sub-atmospheric pressure on the wound using a sealed foam dressing and suction apparatus, which encourages the removal of exudate, edema, enhances perfusion, and stimulates the formation of granulation tissue [2]. Initial animal and early clinical studies revealed that negative pressure led to faster granulation and fewer bacteria in experimental wounds, and had a mechanistic explanation of applying VAC to contaminated traumatic wounds [2]. The use of VAC as a temporary or adjunctive modality in the treatment of high-energy open tibial fractures, in particular, Gustilo-Anderson type III injuries in which early soft-tissue coverage can be delayed by patient instability or the unavailability of immediate reconstructive alternatives, has become increasingly popular over the past 20 years (3-5). There are also some observational series and comparative cohort studies that have put forward NPWT as potentially reducing the level of deep infection and decreasing the need to perform complex flap operations through enhancing the wound bed and reducing contamination as definitive soft-tissue reconstruction is scheduled (4,5). Retrospective analysis on this subject has also shown that the incidence of deep infections is lower with NPWT compared with conventional dressings after accounting for injury severity [4].

Prospective study data availability is limited; however, it has been shown that in cases of high-energy open fractures, NPWT has supported positive dynamics in prevention of deep infection and wound complications, but the heterogeneity of study design, device settings, treatment period, and definitive closure makes their interpretation more complicated (3). Systematic reviews and narrative summaries shed light on a consistent message that VAC enhances the local wound conditions and, potentially, allows decreasing infection and flap rates in the selected cohorts of Gustilo III fractures. However, authors warn that high-quality and sufficiently powered randomized trials comparing standardized NPWT protocols to modern wound care are scarce (5). Mechanistically, NPWT treats many pathophysiologic causes of infection in open fractures by the elimination of wound exudates that contain bacteria and inflammatory cytokines, the reduction of interstitial edema that impedes microcirculation, and the promotion of the development of strong granulation tissue that leads to ultimate definitive closure (2,6). However, NPWT is a supplement and not a replacement for a careful surgical debridement, skeletal stabilization, and timely final soft-tissue reconstruction; the inappropriate use of long-term temporary therapy without definitive coverage can allow continuing contamination and biofilm development (3,7). With the current load of osteomyelitis following Gustilo Anderson type III tibial fracture and the promising yet inconclusive effects of NPWT, there is a need to conduct a systematic study of NPWT in standardized protocols, the optimal time to convert to definite soft-tissue cover, and comparative benefits to current substitutive strategies. This research will help to reveal the effects of the use of VAC in the prevention of osteomyelitis after serious open tibial fractures, synthesizing the currently available clinical evidence and analyzing the results within the framework of an institutional cohort.

This prospective observational study was conducted in the Department of Orthopedics, Prathima Institute of Medical Sciences, Naganoor, Karimnagar, Telangana. Institutional Ethical approval was obtained for the study after explaining the nature of the study in the vernacular language. Voluntary participation was ensured with the freedom of the patient to withdraw from the study.

Inclusion Criteria

1. Patients with Gustilo–Anderson type IIIA, IIIB, or IIIC open fractures of the tibia.
2. Aged 18 years and above
3. Males and Females.
4. Present to the hospital within 24 hours of injury
5. Provided informed consent and complied with follow-up examinations.

Exclusion Criteria

1. Patients with pathological fractures
2. Patients with pre-existing osteomyelitis or chronic bone infection
3. Osteoporosis
4. Polytrauma with life-threatening injuries
5. Peripheral vascular disease of uncontrolled diabetes mellitus

Based on the inclusion and exclusion criteria, a total of 30 patients with Gustilo–Anderson type III open fractures of the tibial shaft were included in the study. The cases were selected consecutively using a convenience sampling method. The sample size was determined based on feasibility and the availability of eligible patients during the study period of 2 years.

All patients underwent standardized initial management according to Advanced Trauma Life Support (ATLS) principles. Broad-spectrum intravenous antibiotics were administered at presentation and modified based on wound culture and sensitivity reports. Tetanus prophylaxis was given as indicated.

Surgical Intervention and VAC Therapy: After stabilization, emergency surgical debridement was done under appropriate anesthesia in all the patients. Thorough irrigation using normal saline was done, and all the devitalized tissues were removed. External fixation or intramedullary nailing was used to stabilize the fracture, which depended on the fracture pattern and the condition of the soft tissues. VAC therapy to the wound was done after debridement. A sterile foam dressing of polyurethane was inserted into the wound cavity, followed by an adhesive drape and attached to a negative pressure apparatus. Constant negative pressure of -125 mmHg was applied. Sterile dressing changed after every 48-72 hrs. VAC therapy was maintained till the wound had healthy granulation tissue or was found fit to be covered by definite soft tissue.

Definitive Soft-Tissue Covers: Delayed primary closure, split-thickness skin grafts, or flap cover with the surgery team were used to initiate definitive wound coverage depending on the characteristics of the wound. The date and mode of coverage were recorded.

The main outcome measure was the incidence of osteomyelitis, which was determined by clinical symptoms, radiography, and microbiological identification in follow-up. Time to wound healing, the number of debridements, length of stay in hospital, and the necessity to undergo more surgical procedures were all secondary outcomes. The follow-up was carried out at 2 weeks, 6 weeks, 3 months, and 6 months after the injury. Each visit had a clinical assessment and radiological assessment to determine the wound condition, fracture healing, and signs of infection.

Statistical Analysis: All the available data were refined, segregated, and uploaded to an MS Excel spreadsheet and analysed by Statistical Package for the Social Sciences (SPSS) 26 version software in Windows format. The continuous variables were expressed as Mean, standard deviation, frequency, and percentage. The categorical variables were calculated by the Chi-square test, with values of p <0.05 considered significant.

The baseline demographic and injury profile of the cases in the study is given in Table 1. The mean age of the cohort was 38.5 ± 12.4 years (range: 18–65 years). The frequently involved age group was 31–50 years (46.7%), which is considered the economically active age group, followed by 18–30 years (36.7%). This pattern showed that a high incidence of severe open tibial fractures is common in young as well as middle-aged groups. The overall males were 80% and females 20% indicating male dominance in high-energy trauma.

The primary cause of high-grade open fractures was road traffic accidents (the most prevalent mechanism of injury, 73.3%). Less common were falls out of height (20.0) and crush injuries (6.7). In terms of the severity of fracture, Gustilo-Anderson type IIIB fractures made up the majority (50.0%), type IIIA (40.0%), and type IIIC (10.0%), which means that most injuries resulted in massive soft-tissue damage. The average time of the first debridement was 8.2 ± 4.1 hours, and in 53.3% of the patients, debridement was done within 6 hours. The incidence of related injuries in the patients was 30.0%, which may have played a role in postponing the final management and augmenting the risk of complications.

Details of treatment and Surgical parameters are presented in Table 2.  The option of external fixation was also the most commonly used mode of initial fracture stabilization in 60.0% participants, and this shows that the procedure was appropriate in highly contaminated wounds and in terminal soft tissue conditions. Of the cases in which the soft-tissue conditions allowed intramedullary nailing, 40.0% were employed. There were early VAC therapies, and the mean interval between debridement and VAC therapy was 2.1 ± 1.0 hours, indicating good compliance with early wound management protocol. The complexity of these injuries was that most patients underwent two surgical debridements (53.3%), and the mean was 2.1 ± 0.8 debridements. The VAC time was 10.5 ± 3.2 days, which gave sufficient time to prepare the wound to a satisfactory state before final closure. The most prevalent techniques are soft-tissue covers (43.3%), delayed primary closure (33.3%), and flap procedures (23.3%). Its definitive coverage was obtained at an average of 12.8 ± 4.5 days after injury.

Primary and Secondary Outcomes are given in Table 3. Osteomyelitis was found to occur in 13.3% and all patients had culture and histopathological confirmation of the diagnosis. The relatively low rate of infection, in the presence of a high percentage of injuries associated with type IIIB, indicates the possibility of the protective effect of VAC therapy when used in conjunction with timely debridement and proper handling of the soft tissue. The mean wound healing time was 7.2 ± 2.5 weeks, and the mean length of stay was 18.6 ± 6.8 days, showing the long but satisfactory recovery of severe open fractures. 30% of the patients required bone grafting, and fracture union took an average of 6.8 ± 1.9 months. Non-infectious complications were fewer, and the most common of them, which were due to infection, were pin-site infections (16.7%) and wound dehiscence (10.0%). There were low non-union (6.7%) and malunion (3.3%).

Factors associated with the development of osteomyelitis are given in Table 4. There was a higher probability of patients with severe fractures (100% type IIIB/IIIC) developing osteomyelitis. The other contributory factors for osteomyelitis were delayed debridement (more than 6 hours), a higher number of debridements, extended VAC therapy, and delayed definitive coverage (after 14 days). These results imply that the severity of injuries and postponements in significant measures of management continue to be the major predisposing factors to infection, despite VAC therapy.

Microbiological Profile of the four osteomyelitis cases is given in Table 5. The most common organism was Staphylococcus aureus, with MRSA found in 50% of patients who were infected, and Pseudomonas aeruginosa. The infection was diagnosed between 38 and 56 days after the surgery, which confirmed the significant necessity of further monitoring even in the early stages of postoperative time.

The Gustilo–Anderson type III open tibial fracture is characterized by a high frequency of infection as well as osteomyelitis as a result of widespread soft tissue destruction, contamination, and loss of local vascularity [8]. Although trauma care has advanced, the rate of infection reported in the literature is between 10% and 30%, especially in the case of type IIIB and IIIC injuries [9]. The current research compared the effectiveness of applying Vacuum-Assisted Closure (VAC) therapy as an adjunct to prevent osteomyelitis in high-risk fractures. The results of this study showed an incidence of osteomyelitis of 13.3% which is relatively lower than what was reported in the past regarding similar patterns of injury. The demographic background of the cohort was shown as (young adult males and road accidents as the key cause of trauma as the leading injury mechanism), which fits the available epidemiological evidence about high-energy lower limb injuries [10]. The fact that type IIIB fractures accounted for most (50%) of the injuries represented indicates the severity of the injuries included and strengthens the relevance of the findings. Late presentation and related injuries, which are witnessed in a good number of patients, are well-known causes of risk of infection [11].

 Early debridement is the cornerstone of managing an open fracture [8]. In this study, even though half of the patients underwent debridement more than six hours after injury, the risk of infection was less due to early application of VAC therapy during debridement, which would control the contamination of the wound and provide the optimal wound condition. Previous experimental and clinical research has shown that negative pressure wound therapy decreases tissue edema, enhances microcirculation and granulation tissue growth, which enhances host defense mechanisms [12,13]. In this research, the mean period of VAC treatment was about 10 days, which is comparable to other clinical series in this field [14]. Notably, patients developing osteomyelitis needed much more VAC therapy and debridements, which were evidence of more severe injury, rather than ineffectiveness of the method. These results favor the idea of VAC therapy being an addition but not a replacement of comprehensive soft-tissue coverage, which is the principle emphasized in earlier research [15]. Definitive soft-tissue coverage was attained at an average of 12.8 days. Split-thickness skin grafting is the most common method. In the current study, delayed coverage (more than two weeks) was closely related to osteomyelitis, which is not unique since it was found that early flap or graft coverage is a crucial factor in lowering the incidence of infection in severe open fractures [16]. This indicates the significance of synchronized orthoplastic treatment despite the use of VAC therapy. The microbiological profile identified Staphylococcus aureus as the most common pathogen that comprises methicillin-resistant strains, which is consistent with the trends of post-traumatic osteomyelitis [17]. The late introduction of infection highlights the importance of such long-term clinical control of severe open fracture patients. In general, the research results of this study indicated that VAC therapy, when combined with a complex management regimen including early debridement, proper stabilization, and prompt definitive coverage, could help to decrease osteomyelitis rates in Gustilo Anderson type III open tibial fractures. The limitations of the study were due to its sample size, and a control group was not included for comparison. Long-term multi-center comparative studies of this kind are required for generalization of the results.

Within the limitations of the current study, the results showed that Vacuum-assisted closure therapy appears to be a valuable adjunct in the management of Gustilo–Anderson type III open tibial fractures. The application of which results in a lower incidence of osteomyelitis when combined with thorough debridement and fracture fixation, as well as definitive soft-tissue coverage. The overall factors increasing the risk of osteomyelitis were the severity of fractures, delayed debridement, multiple surgical interventions, and delayed time for coverage despite application of VAC therapy. Larger controlled studies are warranted to further define standardized protocols and long-term outcomes.

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