Orthopedics

Feature Article 

Negative Pressure Incisional Therapy and Infection After Direct Anterior Approach Primary Total Hip Arthroplasty

Vineet Tyagi, MD; Joseph Kahan, MD; Patrick Huang, BS; Michael P. Leslie, DO; Lee E. Rubin, MD; David H. Gibson, MD

Abstract

With the aging of the US population, total hip arthroplasty (THA) is becoming an increasingly common procedure. A major concern after THA is reducing infection rates, as infections can cause devastating complications. Improved sterile technique, standardized infection control protocols, and novel dressings have been used to reduce postoperative surgical site infections (SSIs). The use of either silver-impregnated dry dressings or easily applied incisional negative pressure dressings is aimed at reducing the rates of SSIs after primary anterior THA. The authors retrospectively reviewed the medical records of 275 patients who underwent anterior THA at their institution during a 1-year period. Patients were separated into groups based on their surgical dressing. Rates of SSI were documented, and the effects of various factors, including age, sex, body mass index, and comorbidities, were compared between the 2 cohorts. The authors also analyzed high-risk patients to determine whether easily applied incisional negative pressure dressings reduced infections. The use of easily applied incisional negative pressure dressings after primary anterior THA did not have a statistically significant impact on SSI rate (P=.42). There was also no difference in SSI, readmission, or reoperation in the high-risk group. The goal of using an incisional negative pressure wound therapy device is to help further decrease the risk of SSI. This study's findings suggest that the SSI rate in this group did not differ from that in the standard dressing group, such that the prophylactic use of a negative pressure wound therapy device is not indicated for either standard or high-risk patients undergoing primary anterior approach THA. [Orthopedics. 2019; 42(6):e539–e544.]

Abstract

With the aging of the US population, total hip arthroplasty (THA) is becoming an increasingly common procedure. A major concern after THA is reducing infection rates, as infections can cause devastating complications. Improved sterile technique, standardized infection control protocols, and novel dressings have been used to reduce postoperative surgical site infections (SSIs). The use of either silver-impregnated dry dressings or easily applied incisional negative pressure dressings is aimed at reducing the rates of SSIs after primary anterior THA. The authors retrospectively reviewed the medical records of 275 patients who underwent anterior THA at their institution during a 1-year period. Patients were separated into groups based on their surgical dressing. Rates of SSI were documented, and the effects of various factors, including age, sex, body mass index, and comorbidities, were compared between the 2 cohorts. The authors also analyzed high-risk patients to determine whether easily applied incisional negative pressure dressings reduced infections. The use of easily applied incisional negative pressure dressings after primary anterior THA did not have a statistically significant impact on SSI rate (P=.42). There was also no difference in SSI, readmission, or reoperation in the high-risk group. The goal of using an incisional negative pressure wound therapy device is to help further decrease the risk of SSI. This study's findings suggest that the SSI rate in this group did not differ from that in the standard dressing group, such that the prophylactic use of a negative pressure wound therapy device is not indicated for either standard or high-risk patients undergoing primary anterior approach THA. [Orthopedics. 2019; 42(6):e539–e544.]

Total hip arthroplasty (THA) is a highly successful treatment for primary osteoarthritis, with greater than 95% survivorship at 10-year follow-up.1 The demand for THA continues to grow in the United States, and it is estimated that 500,000 primary THAs will be performed annually by 2030.2

Infections are a devastating complication after arthroplasty, being associated with substantial patient morbidity and a large financial burden on the health care system. The incidence of infection in primary hip replacement is approximately 1% to 2%.3 Medical conditions such as obesity, diabetes, and rheumatologic disease have been reported as consistent risk factors for infections after THA.4 As the population ages and the prevalence of these risk factors increases,5 complications surrounding THA are expected to increase.6

The economic consequences of revision arthroplasty have been well studied. The cost of revision surgery grew significantly in less than 10 years, being approximately $55,000 in 2006 and having increased to more than $75,000 by 2013.7 By 2020, it is estimated that the total medical cost of revision arthroplasty surgery in the United States will exceed $1.62 billion.2

Since the advent of THA, many innovative infection control measures have been seen. The efficacy of prophylactic antibiotics for joint arthroplasty has been widely accepted for more than 40 years.8 Minimizing operative time has also been shown to be an effective strategy for reducing the risk of postoperative complications.9 Other clinical countermeasures such as “space suits” or laminar flow-equipped operating rooms have also been successful.5 Additional perioperative measures have recently been undertaken in an attempt to further reduce complications associated with surgical site infections (SSIs).

Negative pressure wound therapy (NPWT) is one intervention that is being used to decrease wound drainage, which theoretically will lead to a decrease in deep wound infection.10 Traditionally used for complicated and non-healing wounds11 or as a bridge between debridement and surgical closure, NPWTs are thought to assist the healing process through several mechanisms, including increasing blood flow, decreasing edema, stimulating angiogenesis, and inducing collagen transcription.12

Currently, the most commonly accepted use of NPWT is for the prophylaxis of wound complications in high-risk closed surgical wounds. There is no research providing specific guidelines or indications for the use of incisional NPWT (iNPWT) after primary anterior approach THA. The authors seek the ability to preoperatively determine candidates at higher risk for prolonged wound drainage and postoperative infection in order to help surgeons determine which arthroplasty patients could benefit most from iNPWT. The authors hypothesized that there would be a lower postoperative SSI rate in patients who were treated with a negative pressure incisional dressing (Prevena; Acelity/KCI, San Antonio, Texas) vs the current “standard” occlusive, antibacterial surgical site dressing (Aquacel; Convatec, Bridgewater, New Jersey), and that this would especially be the case for patients considered to be at high risk for infection.

Materials and Methods

Study Design

The objective of this study was to compare the infection rates between iNPWT (Prevena) and a silver-impregnated occlusive island dressing (Aquacel) after primary THA. After receiving institution review board approval, the authors retrospectively reviewed the electronic medical records of 275 patients who underwent primary THA via a direct anterior approach at their institution from January 2015 to January 2018.

Inclusion criteria were primary THA via a direct anterior approach, using a traction table and fluoroscopy, at the authors' institution performed by a single surgeon (M.P.L.). Exclusion criteria were revision hip arthroplasty, postoperative follow-up of less than 3 months, conversion of a hemiarthroplasty to a THA, and age younger than 18 years. The primary outcome was development of any postoperative SSI. The secondary outcomes were length of stay, readmission, and need for reoperation. Age, sex, American Society of Anesthesiologists (ASA) class, and specific surgical dressing used were determined by reviewing each patient's record. Additional data, including body mass index (BMI), tobacco use, history of autoimmune disease, preoperative international normalized ratio, and procedure details, were also obtained directly from patient records.

Surgical Technique

All THAs were performed by a single surgeon who employed a direct anterior approach using the G7 acetabular cup and press-fit Avenir stem (Zimmer Biomet, Warsaw, Indiana). The surgical technique remained the same throughout the duration of this study, with routine use of a traction table and fluoroscopy during the procedure. The surgeon used a Prevena iNPWT on his primary THAs but switched to a silver-impregnated island (Aquacel) dressing after the implementation of a standardized protocol at the authors' institution in March 2017 for use of this dressing in primary arthroplasty patients.

Statistical Analysis

The authors performed a pre hoc power analysis using infection rates from prior studies13 and determined that 221 patients were needed in both the Prevena and the Aquacel treatment arms. Patient and procedure characteristics were tabulated, and differences between the groups were assessed using Pearson's chi-square test or Fisher's exact test to compare patient demographics, ASA class, and procedure types for patients based on dressing category. All calculations were performed using Stata 13.1 software (StataCorp, College Station, Texas), and the threshold for significance was a type I error rate of 0.05. A separate subgroup analysis was performed by risk-stratifying patients into “standard” and “high risk” patient groups, with the latter defined as patients with a BMI of 30 kg/m2 or greater and/or ASA class of 3 or greater, to determine whether high-risk patients would benefit from iNPWT dressings.

Results

Between January 2015 and January 2018, a total of 275 patients met the study's inclusion/exclusion criteria and underwent a total of 275 THAs via the anterior approach. For 86 patients, iNPWT was used. For 189 patients, silver-impregnated occlusive dressing was used. Patient demographics and baseline characteristics are listed in Table 1. There was no difference in age, sex, ASA class, history of diabetes, smoking status, or autoimmune disease between the 2 groups. Patients who received iNPWT had a higher BMI (mean, 30.9 kg/m2) than patients who received an occlusive dressing (mean, 28.7 kg/m2; P=.00).

Demographics and Baseline Characteristics of the Study Groups

Table 1:

Demographics and Baseline Characteristics of the Study Groups

Overall, there was no difference in the rate of SSI (total, superficial, or deep) between the 2 groups. The overall SSI rate, superficial SSI rate, and deep SSI rate seen in this direct anterior approach THA cohort of 275 cases was 1.45%, 0.72%, and 0.72%, respectively. There was a trend toward higher overall readmission rate in the iNPWT group compared with the occlusive dressing group (9.30% vs 3.70%), but it was not statistically significant (P=.12). When excluding readmissions for reasons unrelated to primary surgery, the readmission rates were similar between the 2 groups (3.49% vs 1.59%; P=.32). There was a trend toward reoperation in the iNPWT group, but this was not statistically significant (P=.18). There was no difference in administration of tranexamic acid, operative time, or length of stay between the 2 groups (Table 2).

Surgical Site Infections, Outcomes, and Operative Data of the Study Groups

Table 2:

Surgical Site Infections, Outcomes, and Operative Data of the Study Groups

In the subgroup analysis of high-risk patients, defined by BMI of 30 kg/m2 or greater and ASA class of 3 or greater, the authors found no statistically significant difference in overall infection rate between the patients treated with iNPWT vs occlusive dressings (2.33% vs 1.06%; P=.42) (Table 2). Each group had 2 infections (1 superficial and 1 deep), and there was no difference in the rate of reoperation or readmission between high-risk patients treated with either kind of dressing. The operative time and length of stay were longer in patients who had a iNPWT dressing (114.9 minutes vs 100.2 minutes), but this difference did not reach statistical significance (P=.16) (Table 3).

Subgroup Analysis of Outcomes in High-Risk Patients

Table 3:

Subgroup Analysis of Outcomes in High-Risk Patients

The high-risk patients accounted for all of the infections (Table 4). Negative pressure wound therapy was used more often in the high-risk group (46.8%) than in the non–high-risk group (31.6%).

Comparison of Prevena Use Between Risk Groups

Table 4:

Comparison of Prevena Use Between Risk Groups

The authors built a multivariate logistic regression with SSIs as their independent variable (Table 5), with a pseudo R of 0.32. The only significant variable was BMI.

Multivariate Logistic Regression With Surgical Site Infection as Independent Variablea,b

Table 5:

Multivariate Logistic Regression With Surgical Site Infection as Independent Variable,

Discussion

Negative pressure wound therapy was initially pioneered in plastic surgery, being subsequently adopted by other surgical fields, including vascular, cardiothoracic, and abdominal surgery.14 More recently, NPWT has been used for clean closed incision management, applied prophylactically to surgical wounds.15

The goal of iNPWT is to help decrease the risk of SSI. Although all infections observed within this study occurred in the high-risk patient cohort, the use of iNPWT did not decrease the incidence of infection. These findings suggest that the prophylactic use of NPWT is not indicated for standard or high-risk patients undergoing primary anterior THA.

Research involving high-risk patients has shown both a reduced incidence of infection and a reduced severity of postoperative hematoma and seroma when NPWT is used.16 However, research specifically examining NPWT in orthopedic surgery is scarce, and NPWT has been infrequently studied regarding its role in reducing prosthetic joint infections in primary THA. Because NPWT devices may add significantly to the overall costs of arthroplasty care, understanding their use for primary THA is worth investigating.

Pachowsky et al17 performed a randomized control trial examining the use of prophylactic NPWT in primary THA. They found a significant improvement in the seroma volume for the group of patients using NPWT. However, this study only investigated development of seroma and did not specifically examine prosthetic joint infection.17 A randomized control trial by Karlakki et al18 examining NPWT in primary total hip and knee arthroplasty found decreased wound exudate and trends toward decreased length of stay and wound-related complications. The study also found that there were fewer dressing changes, as expected, in the NPWT group. Karlakki et al18 did not, however, comment on the cost-effectiveness when compared with standard dressings because they thought that a more detailed analysis would be necessary for financial modeling. Further subgroup analysis showed that NPWT was beneficial in reducing wound complications specifically for higher risk patients with ASA class of 3 or greater and BMI of 35 kg/m2 or greater.13 This was echoed by Siqueira et al,19 who, in a review of the literature, found that NPWT may be most beneficial in those patients deemed high risk for wound complications. These patient-specific factors that they found to be important included high risk of bleeding/hemorrhage postoperatively, patient size/weight, and intraoperative tissue quality.19

Redfern et al20 performed a study comparing a prospective cohort of patients treated with NPWT after primary THA and TKA with a historical control group treated with standard gauze dressings. They found that there was no difference in deep infection rate between the 2 groups, but that the NPWT group had a statistically significantly lower rate of superficial infections. For this study, the baseline characteristics of sex, site of surgery, and several comorbidities were not significantly different between the 2 groups. The study also did not make use of silver-impregnated antimicrobial dressings.15 Cooper and Bas21 showed that, when compared with standard dressings, NPWT did decrease wound complications and total SSIs in patients after revision THA. They also found a trend toward decreased superficial wound dehiscence, deep prosthetic joint infections, and reoperation rate in the NPWT group.

The cost of a standard Prevena dressing has been quoted as $495, while the cost of a standard Aquacel dressing is $15.22 At the authors' institution in June 2018, the acquisition cost was $486 for a Prevena dressing and $39 for an Aquacel dressing. Based on this cost difference, using Aquacel instead of Prevena in the current cohort would have saved nearly $40,000. In addition, the theoretical cost of using Prevena NPWT for all 275 cases would have been $133,650, compared with $10,725 for Aquacel. This would have yielded a cost difference of $122,925, with no improvement in primary THA SSI reduction observed in the data for the more expensive NPWT dressings.

The main limitations of this study were its retrospective design and its underpowered patient enrollment. However, to the authors' knowledge, this study represents the largest comparison between NPWT and other dressings in the literature. To further investigate their effects on postoperative infections, especially for high-risk patients, a prospective multicenter study examining wound dressings and clinical outcomes is needed.

Studies have shown that the learning curve for the anterior approach is approximately 100 cases, with complication rates decreasing after this threshold.23–25 The current surgeon had been using the anterior approach for all of his primary THA cases for more than 5 years. He had performed well more than 100 cases using this approach by the time this study was initiated. However, the study of a single surgeon's cases, while intended to eliminate any variables of surgical technique or inconsistent patient selection, is not ideal. A larger cohort may have led to expanded data collection and further strengthened the current results. Randomized studies with more surgeons are needed to further elucidate the role of NPWT in primary anterior approach THA.

To the authors' knowledge, this is the first study examining NPWT in a large cohort of primary anterior approach THAs. The study was designed such that the data were internally peer reviewed by 2 senior surgeons who did not perform any cases in the cohort, which also served to further strengthen the analysis. Despite the limitations of this study mentioned above, the reported results are an important addition to the literature.

Conclusion

These findings suggest that the use of iNPWT did not lead to a reduced rate of SSI in patients undergoing primary anterior approach THA. Also, the authors found no difference in infections in a high-risk patient subgroup within the cohort. Given the significant difference in acquisition costs between these 2 types of dressings, these data do not lend objective justification to continued use of iNPWT dressings. As a result of these data, the authors have since abandoned the use of iNPWT for primary anterior approach THA. Further study is needed regarding the use of iNPWT dressings in high-risk and revision hip arthroplasty cases.

References

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Demographics and Baseline Characteristics of the Study Groups

CharacteristicAquacel GroupPrevena GroupP
Patients, Total no.18986
Age, mean, y60.561.9.41
Male49.7%41.9%.23
Body mass index, mean, kg/m228.730.9.00
American Society of Anesthesiologists class, mean2.42.41.00
Diabetes diagnosis13.2%18.6%.25
Smoker11.6%11.6%1.00
Autoimmune diagnosis9.0%8.1%.82

Surgical Site Infections, Outcomes, and Operative Data of the Study Groups

CharacteristicAquacel GroupPrevena GroupP
Patients, Total no.18986
Surgical site infection1.06% (n=2)2.33% (n=2).42
  Superficial, No.11
  Deep, No.11
Readmission3.70% (n=7)9.30% (n=8).12
Readmission secondary to primary surgery1.59% (n=3)3.49% (n=3).32
Reoperation secondary to infection from primary surgery0.53% (n=1)2.33% (n=2).18
Tranexamic acid administered77.8%82.6%.37
Operative time, mean, min100.698.6.69
Length of stay, mean, d2.753.11.18

Subgroup Analysis of Outcomes in High-Risk Patients

CharacteristicAquacel GroupPrevena GroupP
Patients, Total no.2522
Surgical site infection8.0% (n=2)9.1% (n=2)1.00
  Superficial, No.11
  Deep, No.11
Readmission12.0% (n=3)13.6% (n=3)1.00
Readmission secondary to primary surgery8.0% (n=2)13.6% (n=3).65
Reoperation secondary to infection from primary surgery4.0% (n=1)9.1% (n=2).59
Tranexamic acid administered56.0%68.2%.55
Operative time, mean, min100.2114.9.16
Length of stay, mean, d2.843.81.20

Comparison of Prevena Use Between Risk Groups

CharacteristicHigh-Risk GroupNon–High-Risk GroupP
Patients, Total no.47228
Infection8.5% (n=4)0.0% (n=0)<.0001
Prevena46.8% (n=22)31.6% (n=72).01

Multivariate Logistic Regression With Surgical Site Infection as Independent Variablea,b

CharacteristicOdds Ratio (95% Confidence Interval)P
Prevena2.031 (0.190–21.763).56
Age1.000 (0.904–1.107).99
Sex1.719 (0.183–16.168).64
Body mass index class3.027 (1.091–8.402).03
American Society of Anesthesiologists class3.670 (0.375–35.933).26
Diabetes mellitus0.321 (0.019–5.296).43
Tranexamic acid0.099 (0.005–1.827).12
Authors

The authors are from the Department of Orthopaedics and Rehabilitation, Yale University School of Medicine, New Haven, Connecticut.

Dr Tyagi, Dr Kahan, Mr Huang, and Dr Leslie have no relevant financial relationships to disclose. Dr Rubin is a paid consultant for DJO Global, DePuy, and Thompson Surgical and holds stock in 3D Surgical. Dr Gibson is a paid consultant for Exactech and Maxx Health.

Correspondence should be addressed to: Vineet Tyagi, MD, Department of Orthopaedics and Rehabilitation, Yale University School of Medicine, 47 College St, New Haven, CT 06520 ( vineet.tyagi@yale.edu).

Received: August 29, 2018
Accepted: November 01, 2018
Posted Online: September 12, 2019

10.3928/01477447-20190906-06

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