Treatment of Infection With Improved Pulsed Lavage

Objective. To develop a more effective surgical lavage technique to improve the efficacy of treatment for infections after a tibia/fibula fracture. Methods. A retrospective analysis was performed on 46 patients who received pulsed lavage with a side-hole double-valve lavage tube in the Second Hospital of Tangshan, Tangshan, China. Patients with the same injury treated with conventional lavage techniques in the same period were used as controls. The lavage success rate and the infection cure rate were analyzed to evaluate this therapy. Results. All patients showed wound healing by first intention, and there was no recurrence during the follow-up period of > 12 months. Compared to the control group, the group that received pulsed lavage showed higher lavage success rates and cure rates. Conclusion. Pulsed lavage therapy with a side-hole double-valve lavage tube can improve the efficacy of treatment infections after tibia/fibula fractures and constitutes an effective modification to conventional lavage techniques.

Tibia/fibula fractures are usually caused by a traumatic accident. As the fracture sites often have poor soft tissue coverage and blood supply, complex infections frequently occur as a result of nonhealing tissue defects and bone exposure or internal fixation. Hence, infections after tibia/fibula fracture are difficult to treat. Previously, lavage debridement therapy was used for the treatment of such infections,¹ but conventional lavage therapy has a low rate of efficacy due to the potential for detachment and clogging of the drainage and lavage tubes. A pulsed lavage therapy technique with a side-hole double-valve lavage tube was designed to overcome these difficulties.   In the present study, a retrospective analysis of 46 patients who received the new pulsed lavage therapy in the Second Hospital of Tangshan, Tangshan, China, between March 2001 and May 2008 was performed. Patients treated with conventional surgery during the same period were used as controls. The lavage success rate and the infection cure rate were analyzed to evaluate the use of pulsed lavage therapy in the management of tibia/fibula fractures.

Diagnosis of infection post-tibia/fibula fracture. Informed consent was obtained from all individuals included in this study. This study complies with the ethic guidelines of the institution involved. The standard criteria for the diagnosis of orthopedic postoperative infection have yet to be determined. Hence, an integrated approach is used for diagnosis,² and the selected cases met at least 2 of the following criteria: 1) local pain, swelling, fistula formation, and repeated pus-stained exudate, sometimes associated with a systemic fever; 2) bacterial pathogens were grown in the bacterial culture of secretions or material removed from the lesion; 3) laboratory analyses of leukocyte count (WBC), C-reactive protein (CRP), and erythrocyte sedimentation rate (ESR) that support the diagnosis of infection; and 4) X-ray images that show bone destruction, a periosteal reaction, or sequestrum formation at the site of the infection.   Case selection. Cases of infection after fracture of the tibia/fibula treated with lavage therapy in the study period were selected retrospectively from the medical records. Patients were excluded from the analysis if they had diabetes, any neoplasm, a history of immunodeficiency, or incomplete clinical records. All patients had the lesions in the tibia/fibula cadres. The test group included 28 cases of open fractures and 18 cases of closed fractures, while the control group included 26 cases of open fractures and 20 cases of closed fractures. The data were input into a database using Microsoft Excel software. The patients were preliminarily divided into 2 groups: the test group in which the patients were treated with the pulsed lavage therapy with a side-hole double-valve lavage tube, and the control group in which the patients were treated with conventional lavage therapy. In addition to treatment time period, sex, and age, patients were matched between the 2 groups based on the infection course (acute infection, ≤ 2 weeks; chronic infection, > 2 weeks) and fracture sites. Patients who did not have a matched pair were excluded from the study. The final case number was 46 for each group. For all patient pairs, the treatment period was < 1 year. Analysis of the medical indices did not reveal any significant difference between the 2 groups (P > 0.05) (Table 1).   Surgical procedures. For the test group, all infected tissue, necrotic tissue, and pathological dead space was eliminated during the surgical process. For patients who underwent internal fixation, the fixation was removed according to the degree of infection. The side-hole double-valve lavage tube was made of a standard disposable and sterile blood transfusion device. During surgery, the device was opened and holes were cut under sterile conditions. Based on the size of the infected area, side holes were made on the tube in a spiral arrangement with an interval of 0.5 cm -1 cm (Chinese National Patent No. ZL201020122624.8). The side holes had a diameter that was between one-third and one-fourth that of the tube. As shown in Figure 1, the lavage tube was inserted through the healthy skin, at least 5 cm away from the area of infection, with the side holes within the infected area. Each end of the tube had a connector and a transfusion rate-limiting valve. The lavage tube was connected to the lavage bottle at one end and to a disposable suction drainage bottle at the other end (Weigao Inc, Shandong, China). The thread for the pipe fixation had a 2 cm - 3 cm margin to allow the tube to slide to some extent within the lesion. In the case of a large area of infection, 2 sets of lavage tubes could be placed at different sites.   During the postoperative hospitalization, antibiotics were administered intravenously based on bacterial susceptibility until symptoms resolved and physical and laboratory examinations were normal. The wound dressing was changed once a day. Saline was used as the lavage fluid (5,000-8,000 ml/day), and the lavage speed could be controlled by patients or nursing staff. Normally, the lavage was continuous at a speed of 60 drops per minute, and the pulse lavage was given once per hour. During the pulsed lavage, the 2 valves were maximally opened. The drainage valve was closed when the eluate became clear, and reopened when the patient felt pain. The procedure was repeated 2 to 3 times. Overnight, lavage was given at a slower speed. If the lavage tube clogged, a doctor following strict sterile technique gently rotated and manipulated the lavage tube to release the blocklage. Depending on the extent of the infection, the lavage period normally lasted 2-3 weeks.   Before the lavage tube was extubated, the following criteria needed to be reached: 1) if the patient felt pain within 2-3 seconds of the lavage valve being opened and the drainage valve closed, there was no discharge at the sites of lavage, and there was no clogging, then the pathological dead space can be determined as eliminated; and 2) the drainage fluid was clear, and a negative bacterial test result was confirmed after 2 to 3 bacterial cultures.   The lavage and drainage tubes were removed gradually. After they were both thoroughly disinfected and it was confirmed they could freely slide, the tube was cut at the lavage end, pulled out from the drainage end in stages over 2-3 days, and completely removed by the third day.   The surgery and lavage treatment in the control group were similar to the test group, with the following exceptions: the lavage tube and the drainage tube were separate, any clogging was removed using a pressure suction method or an injection syringe, and the lavage liquid itself contained antibiotics.

Lavage success rate. For the test group, no tube detachment occurred during the lavage period, and tube clogging was rapidly solved using the method previously described. Hence, the lavage was performed with a 100% success rate. In the control group, there were 2 cases of tube detachment and 16 cases of incomplete lavage caused by tube clogging, resulting in a significantly lower success rate of 61% (P < 0.05).   Secondary infection. For the test group, there were 6 cases of secondary infection at the lavage and drainage sites. All infections were controlled within 3-5 days by redressing and disinfection. As a result, the extubation time and wound healing were unaffected. In the control group, there were 5 cases of secondary infections that did not cause long-term sequelae and were managed conservatively. There was no significant difference in the rate of secondary infections between the 2 groups (P > 0.05).   Infection cure rate. By the end of the 1-5 year follow-up period (median value: 18 months for the test group, 21 months for the control group), there was no recurrent infection in the test group, which gave a cure rate of 100%. In contrast, 12 recurrent infections developed within 6 months after the initial treatment in the conventional lavage group, leading to a significantly lower cure rate of 74% (P < 0.05). Two typical cases are shown in Figures 2 and 3.

In the present study, cases were selected based on integrated criteria. Although bacterial culture has been used as a conventional approach for the diagnosis of infection, it cannot be the sole method due to the large variation caused by sampling and cultivation variability. Soultanis et al³ showed, in a series of 5 cases of infection following the removal of internal fixation, 2 cases were positive for bacterial growth in the second, but not the initial, culture. Kirkpatrick et al⁴ suggested the formation of exudates and sinuses following internal fixation should always raise the suspicion of infection, until proven otherwise. Hence, basing the case selection for this study on integrated criteria improved the accuracy of the diagnosis.   In recent years, research regarding infection after a tibia/fibula fracture has been focused on bone segment slip technology, antibiotic implantation, and the vacuum sealing drainage approach. Although these therapies have certain advantages, their application has been inhibited by associated limitations, such as high cost, long duration of treatment, significant pain, and limited indications to enable development.^5,6 Compared to these therapies, the lavage therapy is much cheaper and is simpler to perform. In many cases, lavage therapy can be used in combination with these therapies to achieve a better overall efficacy.   At present, the commonly used lavage techniques can be classified into 2 types: the single-tube and double-tube lavage systems, in which the lavage and drainage tubes are separated. For the latter, larger areas of detached tissues and blood clots can be easily sucked into the tube as the size of the drainage tube entry site is the same as the tube diameter. This can lead to the tube becoming clogged. With a single-tube approach, although there is less clogging, the lavage fluid can “short-circuit” the system, which in turn results in low efficacy rates. Although great efforts have been made to improve lavage techniques, progress has been limited. As a result, some surgeons use open lavage as a substitute.   With the side-hole double-valve lavage tube system, a drainage valve is added to the single-tube lavage technique. In this study, the authors found the presence of negative pressure during surgery meant that the liquid in the single-tube mode was almost all eluted through the short-circuit, but not through the side holes; in contrast, when the drainage valve was closed, liquid could pass through the side holes and fill the lesion within a few seconds. With the intermittent opening of the drainage valve, a pulsed lavage mode can be achieved with full lavage followed by full drainage. This technique can effectively avoid the short-circuiting of the lavage liquid and subsequently improve the efficiency of the process.   Previous studies by Beam⁷ and Anglen⁸ have suggested it is unnecessary to supplement the lavage liquid with antibiotics. Consistent with this notion, the authors did not apply antibiotics in the lavage liquid but still achieved high rates of efficacy in this series.   Importantly, the side-hole double-valve lavage tube is based on a single tube and thus avoids the risk of tube detachment. Furthermore, the size of the side holes is smaller than the tube diameter, which avoids clogging; the rare cases of clogging can be resolved simply by rotating and sliding the tube. The authors’ results indicate that although the sliding of the tube can increase the risk of infection at the insertion site, these infections were far enough from the internal site of infection and could be easily cured by careful dressing and conservative treatment as a result of the drainage function of the tube.

The treatment of infection after fracture of the tibia/fibula is complex, as a consequence of the long treatment times, high costs, and risk of long-term physical disability. Therefore, greater efforts should be made to prevent the occurrence of postoperative infections and to improve the management of these infections when they do occur. In the present study, the authors demonstrated that the pulsed lavage therapy with a side-hole double-valve lavage tube can improve the efficacy of treatment of infection following tibia/fibula fractures, and constitutes an effective modification to conventional lavage techniques. Therefore, this novel technique gives a useful adjunct to the currently used lavage-based methods of treatment.

The authors thank Medjaden Bioscience Limited (Hong Kong) for assisting in the preparation of this manuscript with proofreading and editing services.

The authors are from the Second Hospital of Tangshan, Tangshan, China.

Address correspondence to: Zuoming Yang, MD Department of Orthopedics The Second Hospital of Tangshan Tangshan 063000, China yangzuoming@126.com

Disclosure: The authors disclose no financial or other conflicts of interest.