Prophylactic antibiotics vs. placebo after hypospadias repair: a multicenter, randomized, double-blind trial
Mark A. Faasse, MD MPH1, Walid A. Farhat, MD2, Rachel Shannon, BS3, Rakan I. Odeh, MD MPH2, Grace M. Yoshiba, MD3, Fadi Zu'bi, MD2, Ilina Rosoklija, MPH3, Fahad A. Alyami, MD2, Lauren C. Balmert, PhD4, Jennifer L. Beaumont, MS4, Daniel L. Erickson, MS4, Edward M. Gong, MD3, Emilie K. Johnson, MD MPH3, William E. Kaplan, MD3, Gagan Kaushal, PhD5, Martin A. Koyle, MD2, Bruce W. Lindgren, MD3, Dennis B. Liu, MD3, Max Maizels, MD3, Charles R. Marcus, BS3, Theresa Meyer, MS3, Megan Saunders, BScN2, Theresa Thompson, RN2, Elizabeth B. Yerkes, MD3, Earl Y. Cheng, MD3.
1Advocate Children's Hospital, Oak Lawn, IL, USA, 2Hospital for Sick Children, Toronto, ON, Canada, 3Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, IL, USA, 4Northwestern University, Chicago, IL, USA, 5Thomas Jefferson University, Philadelphia, PA, USA.
BACKGROUND: There is variability in the use of prophylactic antibiotics after stented hypospadias repair, and previous studies have had contradictory results as to whether this practice has a favorable impact on surgical outcomes. This study is the first placebo-controlled trial on this subject.
METHODS: Inclusion in this multicenter study was limited to boys under 6 years-old who had a primary, single-stage repair of mid-to-distal hypospadias with placement of an open-drainage urethral stent for an intended duration of 5-10 days. Participants were randomized in a double-blind fashion to receive oral trimethoprim-sulfamethoxazole (TMP-SMX) (4 mg/kg TMP) or placebo twice daily for 10 days postoperatively. The study was discontinued before reaching its targeted enrollment because of an insufficient rate of accrual.
The primary study outcome was a composite of infectious and wound-healing complications, including symptomatic urinary tract infection (UTI), cellulitis/wound infection, urethrocutaneous fistula, meatal stenosis, glans/urethral dehiscence, urethral stricture, and/or urethral diverticulum. Secondary outcomes included acute adverse drug reactions and C. difficile colitis. Analysis was performed on an intent-to-treat basis.
RESULTS: 93 boys were randomized to receive prophylactic TMP-SMX or placebo after hypospadias repair. Two withdrew after randomization, and three were lost to follow-up. The remaining 88 patients had a follow-up visit approximately 6 months postoperatively and a median duration since surgery of 40.3 months (IQR, 31.9-48.8). All patients received intravenous antibiotics at the time of surgery. Other perioperative clinical data are reported in Table 1.
Infectious and/or wound-healing complications occurred in 10 of 41 boys (24.4%) who received prophylactic TMP-SMX as compared with 5 of 47 boys (10.6%) who received placebo (relative risk, 2.29; 95% CI, 0.85 to 6.16) (Table 2). There were no significant differences between groups in symptomatic UTI, cellulitis/wound infection, or any wound-healing complications. Adverse drug reactions occurred in 3 of 41 boys (7.0%) who received TMP-SMX as compared with 5 of 47 boys (10.4%) who received placebo (RR, 0.67; 95% CI, 0.17 to 2.64).
CONCLUSION: Compared to placebo, postoperative prophylactic antibiotics did not reduce infectious and/or wound-healing complications after repair of mid-to-distal hypospadias with placement of an open-drainage urethral stent.
|Age, mos; median (IQR)||9.7 (8.0-11.4)||9.7 (7.9-12.1)|
|Intraoperative Urine Culture Obtained; N(%)||7 (16.3%)||5 (10.4%)|
|Meatal Location; N(%)||Glanular||2 (4.7%)||2 (4.2%)|
|Coronal||18 (41.9%)||19 (39.6%)|
|Distal Shaft||18 (41.9%)||22 (45.8%)|
|Mid-shaft||5 (11.6%)||5 (10.4%)|
|Length of Urethral Repair, mm; median (IQR)||9 (7-12)||10 (8-10)|
|Stent Duration, days; median (IQR)||8 (6-9)||8 (6-9)|
|TMP-SMX||Placebo||Relative Risk (95% CI)||P-value|
|Any Infectious and/or Wound-healing Complications||10 (24.4%||5 (10.6%)||2.29 (0.85, 6.16)||0.098|
|Symptomatic UTI||2 (4.8%)||3 (6.3%)||0.76 (0.13, 4.34)||0.999|
|Cellulitis/Wound Infection||1 (2.4%)||1 (2.1%)||1.14 (0.07, 17.71)||0.999|
|Urethrocutaneous Fistula||5 (12.2%)||1 (2.1%)||5.73 (0.70, 47.08)||0.093|
|Meatal Stenosis||1 (2.4%)||0||--||0.466|
|Adverse Drug Reactions||3 (7.0%)||5 (10.4%)||0.67 (0.17, 2.64)||0.717|
|C. difficile Colitis||0||0||--||--|
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