Journal of Pediatric Urology (2021) 17, 256.e1e256.

e5

Comparative analysis of perioperative

a
Arkansas Children’s Hospital, 1
Children’s Way Slot 840, Little
Rock, AR, 72202, USA
b
Baylor Scott and
WhiteeTemple, 2401 S. 31st St,
Temple, TX, 76508, USA
c
University of Arkansas for
Medical Sciences, 4301 W.
Markham St, Little Rock, AR,
USA
* Correspondence to. Jacob C
Smith, 2401 S. 31st St., Temple,
TX, 76508, USA
CanonSJ@archildrens.org (S.
J. Canon)
Jacob.smith@bswhealth.org,
(J.C. Smith)
ECSullivan@uams.edu (E.
Sullivan)
PatelAS@archildrens.org (A.
Patel)
zamilpaI@archildrens.org (I.
Zamilpa)
archildrens (J.C. Smith)
Keywords
Hypospadias; Surgical wound
infection; Anti-bacterial
agents; Stents
prophylactic antibiotics in prevention of
surgical site infections in stented, distal
hypospadias repair
Stephen J. Canon a, Jacob C. Smith b,*, Elizabeth Sullivan c,
Ashay Patel a, Ismael Zamilpa a
Summary
Purpose
There is limited evidence that prophylactic antibi-
otics prevent surgical site infection in stented, distal
hypospadias repair. Our hypothesis is that the use of
prophylactic antibiotics does not affect the rate of
surgical site infection in this setting.
Methods
We conducted a retrospective study of consecutive
patients over a 6-year period with distal penile
hypospadias treated with urethral stenting. Vari-
ables analyzed include age, type of repair, usage of
preoperative and/or postoperative antibiotics, and
length of follow-up. Patients with a history of
proximal or re-operative hypospadias repair were
excluded. Surgical site infection was defined by the
presence of postoperative penile erythema and/or
purulent drainage treated with therapeutic antibi-
otics. Secondary outcome analysis included the
presence of other hypospadias complications.
Results
441 consecutive subjects met our inclusion criteria
with a mean age of 13.3 months. Patients were
categorized into groups: Group 1 e Preoperative
antibiotics (n Z 64), Group 2 e Both Preoperative &
Postoperative antibiotics (n Z 159), Group 3 e
Postoperative antibiotics (n Z 122), Group 4 e No
Preoperative or Postoperative antibiotics (n Z 96).
Two surgical site infections were reported out of the
441 patients: 1 in Group 3 and 1 in Group 4
(p Z 0.513). There was no significant difference in
the total patients with a hypospadias complication
between groups. In the table below, Groups 1e3
were combined (345 patients) for comparison to
Group 4 (No antibiotics, 96 patients) for further
analysis with no difference in SSIs (p Z 0.388) or
respective hypospadias complications.
Conclusions
The use of perioperative prophylactic antibiotics,
both before and after surgery for distal, stented
hypospadias repair, have not been shown to reduce
the rate of surgical site infections nor hypospadias
complications. Consequently, the benefit of pro-
phylactic antibiotics in this setting is unclear.

Abbreviations
SSI, Surgical site infections;
UTI, Urinary tract infection;
ABX, Antibiotic

Received 18 August 2020

Revised 6 November 2020 Summary Table Surgical-related outcomes by antibiotic usage and non-usage.
Accepted 25 November 2020
Available online 30 November Any Administration of Antibiotic No Administration P-value
2020 (PreOp and/or PostOp) of Antibiotics
Number of patients (n) 345 96
Surgical site infection, n (%) 1 (0.3) 1 (1.0) 0.388
Hypospadias complications, n (%) 22 (6.4) 5 (5.2) 0.673
Urethrocutaneous fistula 17 (4.3) 3 (3.1) 0.586
Meatal Stenosis 4 (1.2) 2 (2.1) 0.615
Urethral diverticulum 1 (0.3) 0 (0.0) 0.968
Wound dehiscence 1 (0.3) 2 (2.1) 0.121
UTI 1 (0.3) 0 (0.0) 0.968

https://doi.org/10.1016/j.jpurol.2020.11.033
1477-5131/ª 2020 Journal of Pediatric Urology Company. Published by Elsevier Ltd. All rights reserved.

Downloaded for Anonymous User (n/a) at Ankara Gulhane Egitim Arastırma Hastanesi from ClinicalKey.com by Elsevier on
January 31, 2022. For personal use only. No other uses without permission. Copyright ©2022. Elsevier Inc. All rights reserved.
Antibiotic impact SSIs in distal hypospadias repair
Introduction
Hypospadias is one of the most common congenital anom-
alies with an incidence from 0.3% to 0.7% in live male births
[1], and distal, stented hypospadias repair is a common
procedure performed by pediatric urologists. Surgical site
infections [SSI] are a risk for any surgical intervention and
can complicate up to 5% of clean extra-abdominal opera-
tions [2,3]. However, in hypospadias repairs, SSIs are very
uncommon. The rate of postoperative SSIs following distal
hypospadias repair was noted by Baillargeon et al. to be 2/
150 (1.3%) [4] and by our institution to be 1/224 (0.4%) [5].
Prophylactic antibiotic therapy for patients having surgery
is used to prevent SSIs, but with increasing rates of anti-
biotic resistance [6,7], this practice has been questioned.
In 2008, the American Urological Association [AUA]
released best practice guidelines for the role of prophy-
lactic antibiotics in adult urologic surgery [8], but no such
guidelines exist for urologic surgery in children. Currently,
the mainstay for management of hypospadias repair to
prevent SSI, urinary tract infection [UTI] and other types of
infections is utilization of both preoperatively and post-
operatively prophylactic antibiotics following stented,
distal hypospadias repair [9,10]. In a survey of members of
the Society of Pediatric Urology, preoperative antibiotics
were used by 76.6% of pediatric urologists before distal
hypospadias repair utilizing a postoperative urethral stent
[11].
Based on our previous work and the work of Baillargeon
et al., the data demonstrated questionable benefit to
antibiotic therapy in reducing the rate of SSIs [4,5]. Both
series primarily reviewed the administration of preopera-
tive antibiotics with only a small subset of patients under-
going hypospadias repair without receiving any antibiotics
postoperatively as well. Because of growing concern of
worsening antibiotic resistance patterns as well as skepti-
cism of the benefit of postoperative antibiotic therapy in
prevention of post-procedural symptomatic UTIs [12], our
group began performing stented, distal hypospadias repair
without preoperative or postoperative antibiotic therapy.
No data exists comparing the incidence of SSIs in patients
undergoing primary distal, stented hypospadias repair with
antibiotic therapy to a large control group having surgery
with no perioperative antibiotic therapy. The purpose of
this study is to compare patients with a history of stented,
distal hypospadias repair who had received preoperative
and/or postoperative antibiotic therapy to those patients
who had not received prophylactic antibiotic at all around
the time of this surgical repair.
Methods
After IRB approval (IRB Protocol #206966), we retrospec-
tively queried the Division of Urology Hypospadias Database
for all patients treated with stented, distal hypospadias
repair from January, 2011 and February, 2017, by three
surgeons at our institution. Consecutive patients with distal
penile, coronal, and balanic hypospadias treated with
hypospadias repair with urethral stent drainage were
included. Variables collected and analyzed include age at
surgery, type of hypospadias repair, usage or non-usage of
Downloaded for Anonymous User (n/a) at Ankara Gulhane Egitim Arastırma Hastanesi from ClinicalKey.com by Elsevier on
January 31, 2022. For personal use only. No other uses without permission. Copyright ©2022. Elsevier Inc. All rights reserved.
256.e2
preoperative and/or postoperative antibiotics, and length
of follow-up. Patients with a history of proximal or re-
operative hypospadias repair were excluded from the
study.
The primary outcome of the study was the presence of
postoperative SSI upon surgeon evaluation, defined as the
presence of post-op penile erythema and/or purulent
drainage treated with therapeutic antibiotics within one
month of surgery. The secondary outcome of the study was
the presence of other hypospadias repair complications
(urethrocutaneous fistula, meatal stenosis, wound dehis-
cence, UTI and urethral diverticulum) between patients
who received antibiotic therapy as compared to those who
did not.
Patients treated with preoperative antibiotic therapy
received standard preoperative cefazolin 30 mg/kg intra-
venously or clindamycin 10 mg/kg for patients with a
penicillin allergy. Also, for patients receiving postoperative
antibiotic therapy, the standard practice at our institution
previously consisted of sulfamethoxazole/trimethoprim
(2 mg/kg once daily) unless sulfa allergy, in which case
nitrofurantoin (1e2 mg/kg once daily) or cephalexin
(10e15 mg/kg once daily) prophylaxis was utilized, during
the urethral stenting period.
Following hypospadias repair, patients were typically
dressed with either 2-octyl cyanoacrylate or waterproof
transparent dressing based upon surgeon preference with
two of the three surgeons typically utilizing 2-
octylcyanoacrylate [13]. Follow-up for hypospadias repair
at our institution typically consists of urethral stent
removal approximately 5e8 days after surgery and subse-
quent reevaluation 3e4 months later with additional eval-
uations as needed. At the time of urethral stent removal,
each patient was evaluated by our nurse practitioner or one
of the surgeons on our team for signs of SSI or any com-
plications of hypospadias surgery.
Statistical analysis
Continuous variables are presented as means and standard
deviations. Categorical variables are shown as frequencies
and percentages. A log-transformation was applied to the
variables, age at surgery and length of follow-up, to
decrease skewness and kurtosis of the data. Transformed
data only were used in the statistical analysis; raw values
are shown in tables.
Surgical outcomes were compared between antibiotic
usage groups using chi-square or Fisher’s exact test as
appropriate for categorical variables and independent
samples t-tests for continuous variables. The data were
analyzed with SAS software version 9.4 (SAS Institute Inc.,
Cary, NC, USA).
Results
Based on the query of the database, 441 consecutive pa-
tients met the inclusion criteria. Patients were catego-
rized into four separate groups based on antibiotic usage:
Group 1ePreoperative antibiotics only (n Z 64), Group
2eBoth Preoperative & Postoperative antibiotics
(n Z 159), Group 3ePostoperative antibiotics only
256.e3 S.J. Canon et al.

(n Z 122), Group 4eNo Preoperative or Postoperative Discussion

antibiotics (n Z 96).
The mean age at surgery for all patients was 13.3
months (SD Z 11.9). Patients in Groups 2 (14.6 months)
and 3 (14.5 months) were older at the time of surgery
than patients in Groups 1 (12.0 months) and Group 4
(10.5 months) (p < 0.001). The majority of patients un-
derwent tubularized incised plate (TIP) urethroplasty
(73e87%, Table 1), and all patients in the study were
circumcised.
Two SSIs were reported out of the 441 patients: 1 in
Group 3 (post-op antibiotics only) and 1 in Group 4 (No pre-
op or post-op antibiotics) (p Z 0.513). Neither of the pa-
tients with postoperative SSI were found to have subse-
quent hypospadias complications, and both SSIs resolved
with a course of therapeutic antibiotics (sulfamethoxazole/
trimethoprim and amoxicillin/clavulanic acid therapy for 7
days, respectively).
Table 1 also presents the overall number of complica-
tions per cohort. There was no significant difference in the
total patients with a hypospadias complication between
any groups. Three of the groups had fistula rates less than
4% and the postoperative antibiotic only group had a rate of
7.4%. However, there was no statistical difference in this
complication of hypospadias repair between the groups
(p Z 0.412). Symptomatic UTIs were also rare with 1 such
morganella morganii UTI in Group 1 (Pre-Op antibiotics
only). Groups 2 (64.6 months) and 3 (63.6) had longer
average follow up than Groups 1 (40.1) and 4 (34.6)
(p < 0.001).
In Table 2, Groups 1e3 were combined (345 patients) for
comparison to Group 4 (No antibiotics, 96 patients) for
further analysis with no difference in SSIs (p Z 0.388) or
respective hypospadias complications.
Utilization of antibiotic therapy both before and after
surgery for stented, distal hypospadias repair has been
common practice for many years. In recent years, the use
of prophylactic antibiotics for distal, stented hypospadias
repairs has been questioned [4,5,14,15]. Despite the
growing evidence that challenges the need for prophylatic
antibiotic therapy in prevention of symptomatic UTIs and
SSIs in this population, no clinical guidelines exist with the
majority of pediatric urologists reporting continued
adminstration of antibiotics in conjunction with hypospa-
dias repair. In fact, a 2010 survey of members of the Society
of Pediatric Urology revealed that more than 75% of the
members preferred to use preoperative prophylactic anti-
biotics, and 91% of these surgeons also use postoperative
antibiotics as well [11]. Antibiotic resistance is growing
problem in the practice of pediatric urology with increased
resistance to multiple antibiotics, including trimethoprim-
sulfamethoxazole (TMP-SMX) up to 31% for boys, typically
used for uropathogens [6]. Thus, there is an importance in
determining the best practice for antibiotics in distal
hypospadias procedures.
The rate of distal hypospadias infectious complications,
such as SSIs and symptomatic UTIs, are uncommon. Kanar-
oglou et al. reported an absence of symptomatic UTIs for
patients treated both with (n Z 78) and without post-
operative antibiotics (n Z 71) after distal hypospadias
repair [14]. However, all patients in this study received
preoperative antibiotic therapy upon the induction of
anesthesia. Two subsequent retrospective studies evalu-
ated distal hypospadias repair without preoperative anti-
biotic therapy for the prevention of SSIs. Baillargeon et al.
studied 150 patients with 62 receiving preoperative

Table 1 Outcomes related to surgery for repair of hypospadias by antibiotic usage.

PreOp Both PreOp& PostOp No P-value
ABX Only PostOp ABX ABX only ABX
Number of patients (n) 64 159 122 96
Age at surgery (months), 12.0 (12.8)a 14.6 (14.0)b 14.5 (8.5)b 10.5 (10.8)a <0.001
mean (SD)
Type of repair, n (%) 0.115
TIP 47 (87.0) 116 (73.0) 96 (79.3) 82 (87.2)
Thiersch-duplay 3 (5.6) 29 (18.2) 21 (17.4) 9 (9.6)
MAGPI 2 (3.7) 9 (5.7) 4 (3.3) 3 (3.2)
Barcatt 0 (0.0) 2 (1.3) 0 (0.0) 0 (0.0)
GAP 2 (3.7) 1 (0.6) 0 (0.0) 0 (0.0)
Surgical site infection, n (%) 0 (0.0) 0 (0.0) 1 (0.8) 1 (1.0) 0.513
Hypospadias complications, n (%)
Urethrocutaneous fistula 2 (3.1) 6 (3.8) 9 (7.4) 3 (3.1) 0.412
Meatal Stenosis 0 (0.0) 1 (0.6) 3 (2.5) 2 (2.1) 0.459
Urethral diverticulum 0 (0.0) 0 (0.0) 1 (0.8) 0 (0.0) 0.640
Wound dehiscence 0 (0.0) 1 (0.6) 0 (0.0) 2 (2.1) 0.328
UTI 1 (1.6) 0 (0.0) 0 (0.0) 0 (0.0) 0.145
Length of follow-up (months), mean (SD) 40.1 (15.4)a 64.6 (12.8)b 63.6 (21.1)b 34.6 (15.5)a <0.001
SD Z standard deviation. TIP repairs combined Snodgrass with preputial inlay grafts with TIP. Percentages may not sum to 100% due to
rounding or missing values. Means in the same row that do not share the same subscript are different at p < 0.05 according to Tukey’s
studentized range test.

Downloaded for Anonymous User (n/a) at Ankara Gulhane Egitim Arastırma Hastanesi from ClinicalKey.com by Elsevier on
January 31, 2022. For personal use only. No other uses without permission. Copyright ©2022. Elsevier Inc. All rights reserved.
Antibiotic impact SSIs in distal hypospadias repair
Table 2 Surgical-related outcomes by antibiotic usage and non-usage.
Any Administration of
Antibiotic (PreOp and/or PostOp)
Number of patients (n) 345
Surgical site infection, n (%) 1 (0.3)
Hypospadias complications, n (%) 22 (6.4)
Urethrocutaneous fistula 17 (4.3)
Meatal Stenosis 4 (1.2)
Urethral diverticulum 1 (0.3)
Wound dehiscence 1 (0.3)
UTI 1 (0.3)
antibiotic therapy compared with 88 patients who did not
with a single SSI observed in each group [4]. Our group
subsequently compared 89 patients with no preoperative
antibiotics to 135 patients who received preoperative an-
tibiotics for stented, distal hypospadias repair with a single
patient in the no preoperative antibiotic group having an
SSI. Both of these studies provided further evidence that
distal hypospadias treatment without preoperative anti-
biotic therapy appears to not adversely impact the rates of
SSIs and other outcomes [5]. However, the majority of pa-
tients received postoperative antibiotics in both of these
studies except for small subsets of patients: Baillargeon
et al. (10 patients) and Smith et al. (5 patients).
Evidence exists that preoperative antibiotic therapy is
not beneficial for many routine wound class 1 pediatric
urologic surgical procedures in reduction of SSIs [16].
However, in this same study, Ellett et al. strongly encour-
aged the utilization of preoperative antibiotic therapy in
patients having wound class 2 surgical procedures,
including children with hypospadias repair [16]. The Center
for Disease Control defines a wound class 2 surgical pro-
cedure as, “an operative wound in which the respiratory,
alimentary, genital, or urinary tracts are entered under
controlled conditions and without unusual contamination.”
[17] However, we contend that since distal hypospadias is
present in these patients, a surgeon is not actually
“entering” the urinary tract but merely operating on the
exposed skin of the genital tract consistent with a wound
class 1 surgical procedure. Based on this rationale, surgeons
at our institution over the last several years have not
routinely used preoperative antibiotic therapy for distal
hypospadias repairs. In the current retrospective study, we
reviewed all distal hypospadias patients over a 6-year
period and evaluated the outcomes based on different
usage of antibiotics. There were no apparent differences in
the outcomes of SSI between all groups whether perioper-
ative antibiotics were utilized or not. The scarcity of SSIs is
clearly evident in the current study with a 0.45% (2/441)
rate for all patients. This is the first study to include a
cohort with no antibiotics used either before or after sur-
gery for patients treated with stented, distal hypospadias
repair.
Although this is a novel study, there are limitations
worth noting. Since this is a retrospective analysis, this
research is subject to recall bias and potentially inadequate
charting. This study also may be limited by the fact that
some SSIs treated outside of our institution may not have
Downloaded for Anonymous User (n/a) at Ankara Gulhane Egitim Arastırma Hastanesi from ClinicalKey.com by Elsevier on
January 31, 2022. For personal use only. No other uses without permission. Copyright ©2022. Elsevier Inc. All rights reserved.
256.e4
No Administration P-value
of Antibiotics
96
1 (1.0) 0.388
5 (5.2) 0.673
3 (3.1) 0.586
2 (2.1) 0.615
0 (0.0) 0.968
2 (2.1) 0.121
0 (0.0) 0.968
been reported. It is worth noting that our group consists of
the only pediatric urologists in our state of 2.7 million
people. It is possible that patients may have been treated
by their primary care provider without out knowledge,
although this is unlikely since no patients were lost to
follow up during the duration of this study and since there
are no other pediatric urologists in the state. Another lim-
itation is that SSI is an uncommon outcome, and, therefore,
this study may be underpowered to demonstrate a reduc-
tion in SSIs with preoperative antibiotics. The disparate
mean age also is a limitation. Due to expanding manpower
at our institution during the time of this study, the age at
the time of surgery in our institution has steadily decreased
over time. Despite these limitations, we believe that the
study contributes to the literature by retrospectively
analyzing all antibiotic perioperative variations and the
different outcomes for these groups of patients.
Conclusion
The use of perioperative prophylactic antibiotics, both
before and after surgery for distal, stented hypospadias
repair, have not been shown to reduce the rate of surgical
site infections nor hypospadias complications. Conse-
quently, the benefit of prophylactic antibiotics in this
setting is unclear.
Source of funding
This specific study did not receive any funding. However,
many of the patients in the group with no perioperative
antibiotics (Group 4) were part of a small, internally-grant-
funded, randomized trial evaluating the incidence of
symptomatic urinary tract infections in this same patient
population that was previously published [12].
Ethical approval
Not applicable.
Conflict of interest
The authors of have no conflicts of interest to disclose.
256.e5
Acknowledgement
To Beverly Spray, PhD, for her contribution to the statistical
analysis and review of the manuscript.
References
[1] Snodgrass WT, editor. Campbell-Walsh urology. 10th ed. Phil-
adelphia, PA: Elsevier Sounders; 2011. p. 3485e506.
[2] Horwitz Jeffrey, Walter Chwals, Doski John. Pediatric wound
infections: a prospective multicenter study. Ann Surg 1998;
227(4):553e8.
[3] Bratzler Dale, Houck Peter. Antimicrobial prophylaxis for
surgery: an advisory statement from the National Surgical
Infection Prevention Project. Am J Surg 2005;189(4):395e404.
[4] Baillargeon E, Kai D, El-Sherbiny M. The role of preoperative
prophylatic antibiotics in hypospadias repair. Can Urol Assoc J
2014;8(7e8):236e40.
[5] Smith J, Patel A, Zamilpa I, Bai S, Alliston J, Canon S. Analysis
of preoperative antibiotic prophylaxis in stented, distal
hypospadias repair. Can J Urol 2017;24(2):8765e9.
[6] Edlin RS, Copp HL. Antibiotic resistance in pediatric urology.
Ther Adv Urol 2014;6:54e61.
[7] Lake JG, Weiner LM, Milstone AM, Saiman L, Magill SS. Path-
ogen distribution and antimicrobial resistance among pediat-
ric healthcare-associated infections reported to the National
Healthcare Safety Network, 2011-2014. See I Infect Control
Hosp Epidemiol 2018;39(1):1e11.
[8] Wolf Jr JS, Bennett CJ, Dmochowski RR, Hollenbeck BK,
Pearle MS, Schaeffer AJ. Best practice policy statement on
urologic surgery antimicrobial prophylaxis. J Urol 2008;179(4):
1379e90.
Downloaded for Anonymous User (n/a) at Ankara Gulhane Egitim Arastırma Hastanesi from ClinicalKey.com by Elsevier on
January 31, 2022. For personal use only. No other uses without permission. Copyright ©2022. Elsevier Inc. All rights reserved.
S.J. Canon et al.
[9] Shohet I, Alagam M, Shafir R, Tsur H, Cohen B. Postoperative
catheterization and prophylatic antimicrobials in children
with hypospadias. Urology 1983;22(4):391e3.
[10] Meir David, Livne Pinhas. Is prophylatic antimicrobial treat-
ment necessary after hypospadias repair? J Urol 2004;171:
2621e2.
[11] Hsieh MH, Wildenfels P, Gonzales Jr ET. Surgical antibiotic
practices among pediatric urologists in the United States. J
Pediatr Urol 2011;7(2):192e7.
[12] Canon S, Marquette MK, Crane A, Patel A, Zamilpa I, Bai S.
Prophylactic antibiotics after stented, distal hypospadias
repair: randomized pilot study. Glob Pediatr Health 2018;5.
2333794X18770074.
[13] Brockway WJ, Bradsher AJ, Hook JE, Patel AS, Zamilpa I,
Canon SJ. 2-octyl cyanoacrylate hypospadias repair dressing:
a retrospective, controlled comparison. Can J Urol 2019 Feb;
26(1):9675e9.
[14] Kanaroglou N, Wehbi E, Alotay A, Farhat W. Is there a role for
prophylatic antibiotics after stented hypospadias repair? J
Urol 2013;190(Suppl 4):1535e9.
[15] Roth EB, Kryger JV, Durkee CT, Lingongo MA, Swedler RM,
Groth TW. Antibiotic prophylaxis with trimethoprim-
sulfamethoxazole versus No treatment after mid-to-distal
hypospadias repair: a prospective, randomized study. Adv
Urol 2018;2018:7031906.
[16] Ellett J, Prasad MM, Purves JT, Stec AA. Post-surgical in-
fections and perioperative antibiotics usage in pediatric
genitourinary procedures. J Pediatr Urol 2015;11(6):
358.e1e6.
[17] Garner JS. CDC guideline for prevention of surgical wound
infections, 1985. Supersedes guideline for prevention of sur-
gical wound infections published in 1982. (Originally published
in November 1985). Revised. Infect Control 1986 Mar;7(3):
193e200. PubMed PMID: 3633903.