INTRODUCTION

Ankle fractures are among the most common fractures in older adult patients that need surgical treatment. As a result of aging populations, the incidence of these fractures in patients with frailty is rising.1–3 The risk of surgical site infections (SSIs) after ankle fracture surgery ranges between 0.5% and 30%; SSI incidence is higher among older adults.4–15 Outcomes of operative treatment of ankle fractures and the possibility of SSI in older adults remains unpredictable because of comorbidities such as peripheral arterial occlusive disease (PAOD), diabetes mellitus, and cardiovascular disease.16–18 Little is known about risk factors associated with higher postoperative wound complications. Age may be an independent risk factor for SSI6,16,19–21 and was recently described as such by Spek et al11 in their retrospective cohort study.

Not only do SSIs have significant consequences for subjective functional outcomes at 1 year postoperation, but they also necessitate prolonged intravenous antibiotic therapy and wound care.22 Reducing the risk of SSIs is beneficial for reducing healthcare costs. Depending on the type of surgery, an infection could incur additional costs of between £814 and £6,626 due to prolonged hospitalization, readmissions, wound care, and/or additional surgical debridement.23,24 Therefore, SSIs are a financial burden for an already stressed healthcare system.25–27

Because of the increasing incidence of operable ankle fractures and unavoidable associated infections, it is critical to determine risk factors and establish the optimal postoperative wound care to prevent SSIs. Although closed-incision vacuum therapy (CIVT; also known as negative-pressure wound therapy) has established value in prosthetic surgery, literature about its preventive role after orthopedic trauma surgery is limited.28,29

The CIVT modality promotes wound healing by reducing edema and exudate.30 The authors’ hypothesis is that this postoperative wound care lowers the risk of SSIs in traumatic ankle surgery. They performed a pilot study with a CIVT system; the study’s aim was to examine the feasibility of CIVT among older adult patients after ankle fracture surgery.

METHODS

In 2021, the authors conducted a prospective pilot (feasibility) study in a nonacademic teaching hospital in the Netherlands. Patients older than 70 years who presented at the ED with a bimalleolar or trimalleolar ankle fracture were evaluated for possible inclusion in the study. Exclusion criteria were an open fracture, known PAOD (Fontaine classification 2B or higher), paralysis of the fractured side, requiring cast treatment after surgery, revision surgery, and suspicion of or proven cognitive impairment. If a patient met the inclusion criteria, the treating surgeon would explain the study concept, standard treatment, and experimental treatment using CIVT.

Because this small pilot study evaluated a therapy that was already used in this hospital, albeit not for geriatric trauma surgery, the institutional review board determined that no particular approval was required. Patients provided informed consent to participate and could opt out at any time during the study period. A total of 10 eligible patients older than 70 years with a bimalleolar or trimalleolar ankle fracture provided informed consent and were included in the study.

Surgery was performed within 24 hours after trauma in case of a fracture dislocation or postponed due to swelling of surrounding tissue. Postponed surgeries were performed when the surgeon or resident performing the surgery determined the swelling was sufficiently diminished to avoid the impossibility of wound closing, a range of 13 to 20 days. During surgery, an open reduction and internal fixation was performed. Surgeries were performed by two residents under the direct supervision of a consultant trauma surgeon.

After closure of the bilateral wounds with skin staples, a CIVT bandage (Avelle; ConvaTec) was applied to the lateral incision, delivering −80 ± 20 mm Hg continuous negative pressure to the incision. The vacuum bandage was changed after 1 week and applied for another week for a total duration of 2 weeks. The medial incision was covered with a conventional bandage after closure with staples. Staples were removed after 3 weeks, after which the patient was allowed to start weight bearing.

Follow-up was conducted in the outpatient clinic at 1, 2, 3, and 6 weeks postoperatively. During every visit, an author took a conventional photograph of the incision; X-rays were performed after 6 weeks. The authors collected data from patients’ electronic health records in the outpatient clinic regarding patient and wound characteristics, including the general well-being of the patient, possible fever, existence of pain, use of painkillers, redness at the wound edges, possible production of exudate, possible formation of crustae, possible swelling, and expert opinion of wound healing (progression). At the 6-week follow-up, patients completed a short questionnaire addressing their satisfaction with the treatment. The questionnaire included questions regarding pain, wearability, daily experience, general approval of the device, and an open section for any commentary. The authors performed late follow-up between 1 and 2 years postoperatively.

In this facility, SSI is defined as a deep infection involving the tissues under the skin that occurs within 30 days of injury.31 All SSIs after open reduction and fixation of an ankle fracture are therefore approached and treated as deep infections.

RESULTS

Of the 10 participants, the average age was 76.5 years, nine were women, 30% were tobacco users, and one patient had diabetes mellitus. No patients had proven PAOD or used immunosuppressive medication (Table 1). Two patients were operated on within 24 hours of fracture; the mean time until surgery was 13.5 days, with the longest time until surgery being 20 days. Nine patients experienced uncomplicated wound healing of the lateral incision. One patient (10%) developed an SSI 2 weeks after the procedure after premature removal of the vacuum system because of technical failure (see Discussion section; Table 2).

Table 1. - PATIENT CHARACTERISTICS (N = 10) Variable % or Mean (Range) Female 90 Age, y 76.5 (70–86) Diabetes mellitus 10 Smoking habit 30 Peripheral arterial occlusive diseases (Fontaine score ≥ 2B) 0 Immunosuppressive therapy 0 Time until surgery, d 13.5 (1–20)
Table 2. - PATIENT OUTCOMES (N = 10) Outcome % Surgical site infection 10 Transient problems with bandage/pump 40 Satisfied with treatment 6 wk postoperation 100

Six weeks postoperatively, overall satisfaction with the CIVT was high; none of the participants described incapacitating discomfort or disruptive limitations in postsurgical recovery. They disclosed little to no pain and no difference compared with the medial wound side that was treated in the traditional way. Four patients complained of problems with the bandage or pump battery, which had to be changed twice, although these patients did finish therapy. Two patients had discomfort wearing the pump in daily life and said they would prefer a different carry-on system without suggesting specific adjustments. Generally, patients were content with the alternative treatment.

During late follow-up, the first author contacted eight patients (mean, 485 ± 281 days; range, 404-577 days). Three of eight patients (37.5%) could not remember the vacuum therapy. Four of eight patients (50%) specifically recalled the tube being too long and the absence of a user-friendly carry-on system. These were the only practical issues mentioned. Average total costs for the CIVT were €400; this included the materials needed for the bandage change.

DISCUSSION

One patient developed an SSI. This patient was eventually diagnosed with PAOD. Because of the technical failure of the bandage, which was changed after 1 week, vacuum therapy was terminated 8 days postsurgery. No clear cause for the failure was found; there was no excessive production of wound exudate or receding wound edges. Two weeks later, providers suspected a superficial SSI with good secondary healing tendency. Conservative treatment with oral antibiotics was started. Five weeks later, an ankle-brachial index was measured because of stagnant wound healing. Although the patient’s ankle-brachial index was 0.82 at the affected site, follow-up revealed arterial insufficiency. In addition to the patient’s smoking habit, this arterial insufficiency probably played a role in the development of the SSI. After revascularization of significant stenoses in the common iliac artery and the superficial femoral artery, the wound healed well. Fracture and soft tissue healing took 6 months in total to fully recover after the initial trauma. Given this case, the authors advocate the implementation of a standard preoperative vascular evaluation in older adult patients with ankle fractures. This could be a combination of anamnesis and physical examination with an ankle-brachial index to identify possible PAOD.

Based on the authors’ own unpublished data, they anticipated a 25% to 30% chance of SSI in this population.32 However, only one patient developed an SSI. This is lower than the authors’ experience and the incidences found in the literature given standard wound care. Zhou et al33 performed a retrospective study of operated unstable ankle fractures in 76 patients with diabetes that compared CIVT and standard moist wound care. Baseline characteristics of the two groups were not significantly different. The incidence of SSI in the CIVT group was 4.6% compared with 27.8% in the standard wound care group (χ2, 5.076; P = .024). The adjusted odds ratio for the total SSI rate between CIVT and standard wound care was 0.324 (95% CI, 0.092 to 0.804; P = .021).

Canton et al34 conducted a prospective randomized study with 65 patients to compare negative-pressure wound therapy against a conventional dressing. Between the two groups, no need for surgical reintervention or major complications were observed. There was a positive trend in minor complications in the vacuum therapy group (12.6% vs 34.7%).

Limitations

One major limitation of the current analysis is the study design and the small number of patients. This article describes a pilot study and has no statistically significant outcomes. The results cannot be compared with a control group. The authors did not perform a trial randomizing patients to CIVT or conventional dressing groups and thus cannot compare different therapy strategies. As this is a pilot feasibility study, the authors did not perform cost analyses regarding nursing time, possible extra outpatient clinic visits, and time for patient education.

CONCLUSIONS

This small pilot study shows promising results for CIVT after ankle fracture surgery in older adult patients. The intervention appears to be a feasible, safe, and generally well-tolerated therapy to prevent SSIs in postoperative wound healing after open reduction and internal fixation of ankle fracture. Randomized controlled clinical trials need to be conducted to determine the effect of CIVT on wound healing and define which subgroups could benefit the most from this technique.

REFERENCES 1. Kannus P, Palvanen M, Niemi S, Parkkari J, Jrvinen M. Increasing number and incidence of low-trauma ankle fractures in elderly people: Finnish statistics during 1970-2000 and projections for the future. Bone 2002;31(3):430–3. 2. Court-Brown CM, McBirnie J, Wilson G. Adult ankle fractures—an increasing problem? Acta Orthop Scand 1998;69(1):43–7. 3. Thur CK, Edgren G, Jansson KÅ, Wretenberg P. Epidemiology of adult ankle fractures in Sweden between 1987 and 2004. Acta Orthop 2012;83(3):276–81. 4. Lynde MJ, Sautter T, Hamilton GA, Schuberth JM. Complications after open reduction and internal fixation of ankle fractures in the elderly. Foot Ankle Surg 2012;18(2):103–7. 5. Schepers T, de Vries MR, van Lieshout EMM, van der Elst M. The timing of ankle fracture surgery and the effect on infectious complications; a case series and systematic review of the literature. Int Orthop 2013;37(3):489–94. 6. Kelly EG, Cashman JP, Groarke PJ, Morris SF. Risk factors for surgical site infection following operative ankle fracture fixation. Ir J Med Sci 2013;182(3):453–6. 7. Wukich DK, Lowery NJ, McMillen RL, Frykberg RG. Postoperative infection rates in foot and ankle surgery. J Bone Joint Surg 2010;92(2):287–95. 8. Miller AG, Margules A, Raikin SM. Risk factors for wound complications after ankle fracture surgery. J Bone Joint Surg Am 2012;94(22):2047–52. 9. Ovaska MT, Mäkinen TJ, Madanat R, et al. Risk factors for deep surgical site infection following operative treatment of ankle fractures. J Bone Joint Surg Am 2013;95(4):348–53. 10. Shao J, Zhang H, Yin B, Li J, Zhu Y, Zhang Y. Risk factors for surgical site infection following operative treatment of ankle fractures: a systematic review and meta-analysis. Int J Surg 2018;56:124–32. 11. Spek RWA, Smeeing DPJ, van den Heuvel L, et al. Complications after surgical treatment of geriatric ankle fractures. J Foot Ankle Surg 2021;60(4):712–7. 12. Dodd AC, Lakomkin N, Attum B, et al. Predictors of adverse events for ankle fractures: an analysis of 6800 patients. J Foot Ankle Surg 2016;55(4):762–6. 13. Srinivasan CMS, Moran CG. Internal fixation of ankle fractures in the very elderly. Int J Care Injured 2001;32:559–63. 14. Anderson SA, Li X, Franklin P, Wixted JJ. Ankle fractures in the elderly: initial and long-term outcomes. Foot Ankle Int 2008;29(12):1184–8. 15. Aigner R, Salomia C, Lechler P, Pahl R, Frink M. Relationship of prolonged operative time and comorbidities with complications after geriatric ankle fractures. Foot Ankle Int 2017;38(1):41–8. 16. SooHoo NF, Krenek L, Eagan MJ, Gurbani B, Ko CY, Zingmond DS. Complication rates following open reduction and internal fixation of ankle fractures. J Bone Joint Surg 2009;91(5):1042–9. 17. Zaghloul A, Haddad B, Barksfield R, Davis B. Early complications of surgery in operative treatment of ankle fractures in those over 60: a review of 186 cases. Injury 2014;45(4):780–3. 18. Rammelt S. Management of ankle fractures in the elderly. EFORT Open Rev 2016;1(5):239–46. 19. Fisichella L, Fenga D, Rosa MA. Surgical site infection in orthopaedic surgery: correlation between age, diabetes, smoke and surgical risk. Folia Med (Plovdiv) 2014;56(4):259–63. 20. Olsen LL, Møller AM, Brorson S, Hasselager RB, Sort R. The impact of lifestyle risk factors on the rate of infection after surgery for a fracture of the ankle. Bone Joint J 2017;99-B(2):225–30. 21. Varenne Y, Curado J, Asloum Y, Salle de Chou E, Colin F, Gouin F. Analysis of risk factors of the postoperative complications of surgical treatment of ankle fractures in the elderly: a series of 477 patients. Orthop Traumatol Surg Res 2016;102(4):S245–8. 22. Badia JM, Casey AL, Petrosillo N, Hudson PM, Mitchell SA, Crosby C. Impact of surgical site infection on healthcare costs and patient outcomes: a systematic review in six European countries. J Hosp Infect 2017;96(1):1–15. 23. Plowman R, Graves N, Griffin MAS, et al. The rate and cost of hospital-acquired infections occurring in patients admitted to selected specialties of a district general hospital in England and the national burden imposed. J Hosp Infect 2001;47(3):198–209. 24. Coello R, Charlett A, Wilson J, Ward V, Pearson A, Borriello P. Adverse impact of surgical site infections in English hospitals. J Hosp Infect 2005;60(2):93–103. 25. Korim MT, Payne R, Bhatia M. A case-control study of surgical site infection following operative fixation of fractures of the ankle in a large UK trauma unit. Bone Joint J 2014;96-B(5):636–40. 26. De Lissovoy G, Fraeman K, Hutchins V, Murphy D, Song D, Vaughn BB. Surgical site infection: incidence and impact on hospital utilization and treatment costs. Am J Infect Control 2009;37(5):387–97. 27. Whitehouse JD, Friedman ND, Kirkland KB, Richardson WJ, Sexton DJ. The impact of surgical-site infections following orthopedic surgery at a community hospital and a university hospital adverse quality of life, excess length of stay, and extra cost. Infect Control Hosp Epidemiol 2002;23(4):183–9. 28. Karlakki SL, Hamad AK, Whittall C, Graham NM, Banerjee RD, Kuiper JH. Incisional negative pressure wound therapy dressings (iNPWTd) in routine primary hip and knee arthroplasties. Bone Joint Res 2016;5(8):328–37. 29. Cooper HJ, Bas MA. Closed-incision negative-pressure therapy versus antimicrobial dressings after revision hip and knee surgery: a comparative study. J Arthroplasty 2016;31(5):1047–52. 30. Kunze KN, Hamid KS, Lee S, Halvorson JJ, Earhart JS, Bohl DD. Negative-pressure wound therapy in foot and ankle surgery. Foot Ankle Int 2020;41(3):364–72. 31. Horan TC, Andrus M, Dudeck MA. CDC/NHSN surveillance definition of health care-associated infection and criteria for specific types of infections in the acute care setting. Am J Infect Control 2008;36(5):309–32. 32. Dettmers R, Chu G, Weil N, et al. Post-operative infections after open reconstruction internal fixation of ankle fractures; a retrospective analysis. In: EFORT Congress. EFORT Congress; 2016. 33. Zhou ZY, Liu YK, Chen HL, Liu F. Prevention of surgical site infection after ankle surgery using vacuum-assisted closure therapy in high-risk patients with diabetes. J Foot Ankle Surg 2016;55(1):129–31. 34. Canton G, Fattori R, Pinzani E, Monticelli L, Ratti C, Murena L. Prevention of postoperative surgical wound complications in ankle and distal tibia fractures: results of incisional negative pressure wound therapy. Acta Biomed 2020;91:1–12.