Abstract
Abstract
Background:
Currently, various methods of skin closures are used in contaminated and dirty abdominal wounds without solid, evidence-based guidance. This study investigates whether closure methods affect surgical site infection (SSI) and other incisional complications. We hypothesize that open management of the skin would have the lowest complications, including SSI.
Patients and Methods:
Patients age ≥18 who underwent trauma laparotomy (TL) or damage control laparotomy (DCL) from 2008–2013 and had class III/IV wounds were included. Demographic, injury, treatment, and outcome variables were compared based on skin closure methods: Primary closure, intermittently stapled with wicks, or open management. Subgroup analyses for TL, DCL, and high-risk patients with stomach, colon, or rectal injuries were performed. Bivariable and multivariable logistic regression (MLR) analyses were performed to identify risk factors for superficial/deep SSI and surgical incision complications.
Results:
A total of 348 patients were included. The median age was 47 years; 14% were female; 21% had blunt injuries. Overall SSI was highest for open incisions (p < 0.05), but there was no difference in superficial/deep SSI. Primary closures healed a median of 20 days, compared with 68 and 71 days for the intermittently stapled and open groups, respectively (p < 0.001). Primary closure in TL and high-risk patients also had the lowest SSI rates (all p < 0.05), but there were no differences in superficial/deep SSI in any subgroup. In TL patients, diabetes mellitus and colon injuries were independently associated with the development of superficial/deep SSI and surgical incision complications; however, skin closure method was not.
Conclusion:
In class III and IV wounds, primary closure was associated with the lowest SSI, shortest length of stay and healing time. Method of skin closure, however, did not have an independent effect on the development of superficial/deep SSI or surgical incision complications. These suggest that primary skin closure in contaminated and dirty abdominal wounds may be performed more safely than commonly perceived.
S
The most recent report from the NHSN demonstrated a 17% decrease in rates of SSI from 2008 to 2014 [2]. While significant prevention efforts have no doubt contributed to this reduction, SSI still remains a significant source of patient death and healthcare costs [5]. Studies have shown that SSIs increase incidence of incisional hernias to as high as 45% [6], facial dehiscence to 25%, and can lead to necrotizing fasciitis [7,8]. Surgical site infections can also increase the average hospital length of stay (LOS) by 11 days, and add $20,000 to healthcare costs per occurrence [9–11].
Historically, open management of contaminated surgical sites has been used to decrease SSI since the work of Hunter in the 1790s [12] and was shown to be superior to primary closure by Kern in 1806 [13]. Since then, healing by secondary intention and delayed primary closure (DPC) have been studied both nationally and internationally, and have been demonstrated to be effective in lowering SSI [14–18]. A recent meta-analysis of eight randomized controlled trials, however, did not show definitive evidence supporting DPC's ability to reduce SSI [19].These conflicting data mirror the wide variety of closure methods currently used to manage class III and IV wounds [3]. In addition, there are very limited recent data that compare SSI rates between complete skin closure, loose skin closure, and no closure; and this is even scarcer in the trauma literature [20].
This study compares surgical incision complication rates and specifically SSI based on three skin closure methods: Primary closure, intermittent staple with wicks in between staples, and open management. We hypothesized that leaving the incision open would be associated with the lowest SSI and surgical incision complication rates, but would take significantly longer to heal.
Patients and Methods
This study was conducted at MetroHealth Medical Center, a regional level I trauma center. The institutional trauma registry was queried for patients age 18 or older who underwent trauma laparotomy (TL) or damage control laparotomy (DCL) from January 1, 2008 through December 31, 2013, and had class III or IV wounds as defined by the CDC [4].
Patient factors collected included age, gender, body mass index (BMI), active infection on arrival to the trauma bay (referred to as concurrent infection), pre-operative albumin level, and co-morbidities including steroid use, immunocompromised illness, blood alcohol level >0.08 on arrival to the trauma bay, ascites, cigarette use, chronic renal failure, diabetes mellitus, cirrhosis, dementia, psychological illness, cancer, metastatic cancer, and active use of chemotherapy.
Injury variables collected included: Abbreviated Injury Score (AIS) abdomen, Injury Severity Score (ISS), American Society of Anesthesiologists score (ASA), trauma mechanism, perforated organ(s), and peri-operative presence of shock (systolic blood pressure <90 mm Hg). Treatment variables such as injury to operation time, length of operation, type of operation (TL vs. DCL), operative temperature nadir, pre-incision antibiotic agent data (usage, bacterial coverage, timing of delivery, and appropriateness of cessation), peri-operative blood product use, intra-operative culture, post-operative glucose control up to post-operative day (POD) 3, time from date of operation to normalization of lactate and base deficit (lactate <2.5 mmol/L and base deficit between −2–2 mmol/L), and closure method.
The operations in this study refer to the operations in which the fascia was closed. Thus, it was either the operation at the initial TL or in patients who had DCL, at the take-back operation in which the fascia was closed during their initial hospitalization. Patients who did not have primary fascial closure during their initial hospitalization were excluded from the study. Post-operative antibiotic use was deemed appropriate if stopped within 24 hours post-operatively, or if continued for documented diagnosis. Peri-operative blood product use was defined to include the use of any packed red blood cells, fresh frozen plasma, platelets, or cryoprecipitate intra-operatively or within 24 hours from the operation. Skin closure methods included primary closure using suture or staple, intermittently stapled with wicks in between staples, and open with only a few staples approximating the incision (typically around the umbilicus). Incisions closed by other means were not included in the comparison of outcomes by closure method. The DPC is used infrequently at our institution and therefore was not included in this analysis.
Primary outcome variables were any SSI, superficial/deep incisional SSI, and surgical incision complications. SSI included superficial incisional, deep incisional, and organ space infection as defined by the CDC [3] and was determined through documented occurrence in either inpatient and outpatient records. Surgical incision complications were defined as occurrence of any superficial or deep incisional SSI or other complication such as wound dehiscence, hernia, seroma, hematoma, and enterocutaneous fistula. Thus, isolated organ space infections were not considered a surgical incision complication. Secondary outcome variables included intensive care unit (ICU) LOS, hospital LOS, in-hospital death, and incision healing time. Demographics, injury, treatment, and outcome variables were compared based on skin closure methods. Subgroup analyses for TL patients, DCL patients, and high-risk patients with perforated stomach, colon, or intra-abdominal rectum were also performed.
Statistical analyses were performed using IBM SPSS© version 23 (IBM, Armonk, NY). Continuous variables were compared using Student t-test or Kruskal-Wallis test with post hoc analysis as appropriate. Means in this study are reported as mean ± standard deviation, and medians are reported as median (25th–75th percentile). Categoric data were analyzed using either chi-square test or Fisher exact test. Bivariable analyses were performed for factors that may associate with superficial/deep incisional SSI or surgical incision complications. Appropriate variables identified with a p ≤ 0.05 after bivariable analyses were then analyzed using backward stepwise multivariable logistic regression (MLR) to determine independent predictors of superficial/deep incisional SSI and surgical incision complications. Receiver-operating curves were generated from the logistic regression analyses, and the areas under the curve were calculated and expressed as the C-statistics. The odds ratios are reported with 95% confidence intervals. A p value of 0.05 was used to determine statistical significance. This study was approved by the MetroHealth Medical Center Institutional Review Board.
Results
Evaluation by skin closure method
All patients
A total of 348 patients were included; 21% sustained blunt injuries. The majority of patients (76%) underwent TL and 24% underwent DCL. Three hundred and forty-one patients had incision closure by one of the three defined categories; 213 (63%) patients had primary closure, 28 (8%) patients had intermittent staple with wicks, and 100 (29%) patients had open skin incisions. The overall rate of SSI was 18.2%. Superficial/deep incisional SSI occurred in 12.6%, and surgical incision complications developed in 21.9% of patients. Overall in-hospital deaths were 4%. The three groups were similar in age, gender, trauma mechanism, BMI, and co-morbidities (Table 1). Patients with primary skin closure had slightly lower AIS abdomen, ISS, and ASA score compared with the other two groups (all p < 0.05). They also had a lower proportion of colon injury, small intestine injury, and peri-operative shock. In contrast, patients with open skin incisions had the highest proportion of colon and small intestinal injuries, as well as peri-operative shock.
Normally distributed values are presented as mean ± standard deviation, all other values are presented as median (interquartile range). Superscripts denote results of post –hoc analysis: aSignificantly different compared with other two groups; bsignificantly different between primary and open.
BMI = body mass index; AIS = Abbreviated Injury Score; ISS = Injury Severity Score; ASA = American Society of Anesthesiologists score; DCL = damage control laparotomy; abx = antibiotic agents; SSI = surgical site infection; ICU = intensive care unit; LOS = length of stay.
Patients with primary closures had the shortest length of operation and had the lowest intra-operative temperature. They also had a lower proportion of DCL and significantly shorter time from injury to operation, where the fascia was closed (Table 1). All three groups were similar in terms of transfusion needs, post-operative glucose management, and time to normal lactate and base deficit.
Overall SSI rates were lowest in the primary closure group (p = 0.013); however, no differences in rates of superficial/deep incisional SSI were detected. Similarly, surgical incision complications were lowest for the primarily closed and the intermittently stapled groups. The primary closure group had significantly shorter ICU LOS, hospital LOS, and time for incision to heal (Table 1).
TL patients
A total of 263 patients had TL with fascial closure during the same operation; 183 (70%) patients had primary skin closure, 19 (7%) patients had intermittently stapled skin, and 61 (23%) patients had open skin incisions. The three groups were similar in age, gender distribution, trauma mechanism, BMI, co-morbidities, ISS, and ASA. Patients with primary closures, however, had slightly lower AIS abdomen (2.6 vs. approximately 3.0 in the other two groups) and significantly fewer colon injuries. Patients with intermittently stapled skin had the lowest proportion of peri-operative shock (Table 2). Primary skin closures had the shortest median operative time, 110 minutes (80–144), compared with 141 (83–177) and 150 (126–209) minutes for the intermittently stapled and open groups, respectively (p < 0.001). Post-operative antibiotic agents were continued inappropriately more often in patients with open skin incisions (11% vs. 2% in the primary closure group, and 0% in the intermittently stapled group, p = 0.02). It also took a slightly longer time to achieve normal base deficit in patients with open skin incisions (0.9 days vs. 0.1 to 0.2 days in the other groups, p = 0.003).
Normally distributed values are presented as mean ± standard deviation; all other values are presented as median (interquartile range). Superscripts denote results of post hoc analysis: aSignificantly different compared with other two groups; bsignificantly different between primary and open.
AIS = abbreviated injury score; ISS = injury severity score; ASA = American Society of Anesthesiologists score; SSI = surgical site infection; ICU = intensive care unit; LOS = length of stay.
Patients with open incisions had the highest proportion of SSI (p = 0.003) and surgical incision complications (p = 0.033), but there was no significant difference in the rate of superficial/incisional SSI. Patients with primary closures had similar ICU LOS as the remaining groups; however, they had significantly shorter overall hospital LOS and median time to heal (Table 2).
DCL patients
A total of 78 patients underwent DCL and had fascial closure during their initial hospitalization; 30 (38%) patients had primary skin closures, nine (12%) patients had skin intermittently stapled with wicks, and 39 (50%) patients had their skin incisions left open. The three groups had similar demographics, except that the intermittently stapled group was older (p = 0.05). Injury variables, including AIS abdomen and injured organs, among others were also similar, and no differences in treatment variables were seen (Table 3).
Normally distributed values are presented as mean ± standard deviation; all other values are presented as median (interquartile range). Superscripts denote results of post hoc analysis: aSignificantly different compared to other two groups.
AIS = Abbreviated Injury Score; ISS = Injury Severity Score; ASA = American Society of Anesthesiologists score; SSI = surgical site infection; ICU = intensive care unit; LOS = length of stay.
There were no differences in SSI or surgical incision complications based on closure method. Primarily closed incisions healed in a median of 57 days, compared with 111 and 72 days for the intermittently stapled and open groups, respectively; however, this was not statistically significant (Table 3). There were no differences in secondary outcomes such as ICU LOS and overall LOS.
High-risk patients
A total of 144 high-risk patients had a perforation of the stomach, colon, or intra-abdominal rectum; 61 (42%) patients had primary skin closure, 17 (12%) patients had skin intermittently stapled with wicks, and 66 (46%) patients had their skin incision left open. All three groups were similar in patient factors, except that patients with primary closures had slightly lower median BMI (24 vs. 27 in the remaining groups, p = 0.004) and fewer were in peri-operative shock. Also, patients with open skin incisions had an AIS abdomen of 3.3 compared with 2.9 for the other two groups (Table 4). There were no significant differences in peri-operative factors among the three groups.
AIS = Abbreviated Injury Score; ISS = Injury Severity Score; ASA = American Society of Anesthesiologists score; SSI = surgical site infection; ICU = intensive care unit; LOS = length of stay.
High-risk patient subgroup (perforated stomach, colon, or intra-abdominal rectum).
Normally distributed values are presented as mean ± standard deviation; all other values are presented as median (interquartile range). Superscripts denote results of post hoc analysis: aSignificantly different compared to other two groups; bsignificantly different between primary and open.
Patients with primary closures had the lowest rates of SSI, but there were no significant differences in rates of superficial/deep incisional SSI. They also had the shortest ICU and hospital LOS, and their incisions healed in significantly less time (Table 4). Surgical incision complications and wound dehiscence in particular were higher in the open group compared with the other closure methods.
Factors associated with superficial/ deep SSI and surgical incision complications
One of the specific purposes of this study was to evaluate the factors related to the development of surgical incision complications and infections—in particular, superficial and deep incisional SSI. We evaluated TL and DCL patient subgroups separately given the distinct characteristics and peri-operative management of these populations.
TL: Superficial or deep incisional SSI
Superficial/deep incisional SSI developed in 11.1% of the TL population. Factors associated with superficial/deep incisional SSI in this group included older age, diabetes mellitus, colon injuries, and higher median net fluid on POD 0. (Table 5) There were no significant differences in other associated injuries or peri-operative factors such as shock, blood transfusion, and operative duration. Primary closure rates were not statistically different. The TL patients with superficial/deep incisional SSI had significantly longer hospitalization, ICU days, and time to heal, as well as higher rates of wound dehiscence and development of surgical incision complications other than SSI. The MLR demonstrated that older age, diabetes mellitus, and colonic injury were independently associated with superficial/deep incisional SSI in TL patients (Table 5).
Normally distributed values are presented as mean ± standard deviation, all other values are presented as median (interquartile range).
SSI = surgical site infection; BMI = body mass index; AIS = Abbreviated Injury Score; ISS: Injury Severity Score; ASA = American Society of Anesthesiologists score; abx = antibiotic agents; post-op = post-operative; POD = post-operative day; ICU = intensive care unit; LOS = length of stay; TL = trauma laparotomy; CI = confidence interval.
TL: Surgical incision complications
Surgical incision complications occurred in 50 (19.8%) TL patients, 62% of whom had a complication other than a SSI. Factors associated with surgical incision complications in the TL group are shown in Table 6. The MLR demonstrated that diabetes mellitus and colon injury were independently associated with surgical incision complications for patients undergoing TL, but skin closure method was not (Table 6).
Normally distributed values are presented as mean ± standard deviation, all other values are presented as median (interquartile range).
BMI = body mass index; AIS = Abbreviated Injury Score; ISS: Injury Severity Score; ASA = American Society of Anesthesiologists score; abx = antibiotic agents; post-op = post-operative; ICU = intensive care unit; LOS = length of stay; TL = trauma laparotomy; CI = confidence interval.
DCL: Superficial or deep incisional SSI
The rate of superficial/deep incisional SSI was 18.1% in the DCL subgroup. There were no significant differences in demographics, enteric injuries, and peri-operative factors associated with the development of superficial/deep incisional SSI. Primary closure rates were similar between the two groups: 38.5% vs. 32.2%, p = 0.749. The DCL patients with superficial/deep SSI had longer hospital LOS (27 [19–37] vs. 15 [10–22] days, p = 0.002), and time to heal (150 [67–218] vs. 65 [43–31] days, p = 0.018), but no significant difference in ICU days or surgical incision complications other than SSI.
DCL: Surgical incision complications
The overall surgical incision complication rate in the DCL group was 31.9%. There were no statistically significant differences in patient and injury variables with relation to surgical incision complications. Median days from injury to operation, where fascia was closed (2.7 [2.3–6.8] vs. 2.0 [1.7–2.5], p = 0.001), and inappropriate continuation of post-operative antibiotic agents without documented indication (25.0% vs. 4.4%, p = 0.025) were higher in the DCL patients with surgical incision complications. There were no differences detected in other peri-operative factors, including rates of primary closure, 39.1% in those with surgical incision complications compared with 30.6% without a surgical incision complication (p = 0.593). The DCL patients with surgical incision complications had significantly longer ICU days (12 [8–26] vs. 8 [5–14], p = 0.023), LOS (24 [15–39] vs. 15 [10–22] days, p = 0.003), and time to heal (115 [57–183 vs. 65 [39–80] days, p = 0.008) than those without.
Discussion
This study sought to evaluate the impact of skin closure method on SSI and surgical incision complications in trauma patients with contaminated abdominal wounds. Our overall rate of SSI was 18.2%, and 12.6% had a superficial/deep incisional SSI. Rates of SSI in high-risk abdominal wounds vary widely in the trauma literature, between 3% and 45% [20–24], with surgical incision infection rates reported up to 56% for primarily closed surgical incisions [25].
Much to our surprise, patients with primary skin closure had the lowest rates of SSI in our study at 13%; however, there were no significant differences in superficial/deep incisional SSI based on skin closure method. In this study, injuries and patient factors had a greater effect on the development of superficial/deep incisional SSI rather than the method of closure. Evaluation of our TL group demonstrated diabetes mellitus and colon injuries as independent predictors of superficial/deep SSI and surgical incision complications. Interestingly, TL patients in whom surgical incision complications developed were more likely to have had open skin incisions (36.7%) versus any other closure (19.3%, p = 0.013), but this was not independently associated once controlling for other significant variables in our MLR. Despite several subgroup analyses, we were unable to identify a particular population who benefitted from open skin incision management. Even in our high-risk cohort, incision closure method did not significantly change the rates of superficial/deep SSI, which ranged from 12.5% to 21.9%.
Our results are in contrast to other studies that have found open skin incision management to be associated with decreased incidence of SSI in contaminated or dirty abdominal wounds [20–25]. Seamon et al. [20] found that leaving skin incisions open decreased post-operative SSI, and specifically superficial SSI, after high-risk TL when compared with any skin closure (9.8% vs. 31.1%). They also identified DCL as an additional risk factor for superficial SSI. Their overall SSI rate of 44.5% was markedly higher than the 18.2% in this study. This may in part be because of a higher proportion of DCL patients (35.6%) in their study compared with 24% in ours. The DCL patients in our study had a 17.6% rate of superficial/deep incisional SSI, which was slightly higher in the primary closure group than the other two closure methods, but this was not statistically significant.
Our rates are higher than the 7.3% superficial/deep SSI Pommerening et al. found in their cohort of DCL patients [23]. Their primary skin closure group had 13.5% superficial/deep SSI compared with 3.7% in the open group. Our DCL population had greater rates of organ space infections at 10.3% compared with the 2.0% in theirs, which may have contributed to some of the differences seen. Despite their findings, the authors suggested that “primary skin closure may be an acceptable strategy after DCL depending on the level of risk of superficial or deep SSI that patients and surgeons are willing to accept” given that superficial/deep SSI developed in fewer than 85% of their DCL patients with primary closure [23].
While closure method may have played less of a role in the prevention of superficial/deep incisional SSIs in our study, it did have a substantial effect on patient outcomes. Patients with open skin incisions took the longest time to heal, a median of 10 weeks, and had the highest rates of surgical incision complications in all of our subgroups except for the DCL patients. Wound dehiscence in particular remained consistently higher for those with open skin incision management. Shorter incision healing times may translate to improved patient satisfaction and healthcare costs.
Because of the retrospective nature of this study and the complexity of these patients, there are several limitations. First, the number of patients was not distributed evenly across the three skin closure groups, with only 28 patients in the intermittently stapled group. In addition, the DCL group had the least amount of patients of our subgroups analysis. Both of these may have introduced a type II error. Second, the groups were different in the distribution of gastrointestinal tract injuries and other peri-operative parameters. These may reflect some degree of selection bias by the operating surgeons. We attempted to adjust for this, however, via subgroup analyses and MLR, and our results still demonstrated that open management did not decrease SSI and surgical incision complications.
Third, intra-operative antibiotic re-dosing was not captured in this study. However, surgeons in this study were highly compliant with pre-incisional antibiotic agents. Lastly, this study attempted to capture post-operative SSIs and surgical incision complications through review of clinical assessments documented in the electronic medical records. We recognize that tracking post-discharge events retrospectively is very difficult, and it is likely that not all post-discharge surgical incision complications were captured in this study. A randomize controlled trial is likely needed to further elucidate the optimal surgical site closure method for this high-risk population.
Conclusion
The results of this study contrast our own hypothesis and traditional thinking with regard to the benefit of open skin incision management. While there is no question that we should make every effort to prevent SSIs, we should begin to question whether open skin incision management is truly worth the associated morbidity. Are we actually benefiting patients by leaving the skin open or are we just making ourselves feel better?
In trauma patients with class III and IV wounds, primary skin closure was associated with the lowest SSI in overall patients, TL patients, and high-risk patients. Primary closure was also associated with shortest LOS and healing time. Further, open management did not decrease the rate of superficial/deep SSI in any specific groups. Risk factors such as diabetes mellitus and colon injuries were found to be more significant in the development of superficial/deep incisional SSI and surgical incision complications. These findings contrast the dogmatic approach of keeping high-risk abdominal incisions open and suggest that primary closures can be performed more safely than commonly perceived.
Footnotes
Author Disclosure Statement
No competing financial interests exist.
