Abstract
BACKGROUND: Circumcision is a common pediatric urological procedure for phimosis, balanitis, or cultural/religious reasons, but postoperative pain, edema, delayed healing, and infection remain key concerns. This study aimed to evaluate the safety and efficacy of Compound Chamomile-Lidocaine Gel for postoperative wound healing in children undergoing classical circumcision. METHODS: A multicenter, randomized, controlled trial was conducted in 186 boys aged 8-17 years. Participants were randomly assigned to receive postoperative wound treatment with either saline alone (control group) or saline combined with Compound Chamomile-Lidocaine Gel (intervention group). The primary outcome was the degree of local edema 1 week after surgery, assessed by blinded evaluators. Secondary outcomes included maximum pain score (Visual Analogue Scale, VAS) within 2 days postoperatively, wound healing scores (days 3, 7, 14), total wound healing time, cosmetic scores at 4 weeks, patient satisfaction, and infection rates (days 7, 14). RESULTS: In the per-protocol set (PPS), the incidence of moderate-to-severe edema was significantly lower in the intervention group than in the control group (10.59% vs. 24.10%, P=0.04). The intervention group also demonstrated a lower maximum VAS pain score (3.12±1.28 vs. 5.29±1.17, P<0.001) and a shorter mean wound healing time (11.13±4.04 vs. 12.53±2.59 days, P<0.001). However, no significant differences were observed in wound healing scores, cosmetic scores, patient satisfaction, or infection rates. Three adverse events occurred in the control group: wound bleeding on day 3, unexplained fever at 4 weeks, and purulent wound discharge on day 5, all of which resolved with outpatient treatment; no adverse events were reported in the intervention group. CONCLUSIONS: Compound Chamomile-Lidocaine Gel combined with saline significantly reduces edema, alleviates pain, and shortens healing time after pediatric circumcision. These findings suggest its potential value in clinical applications. TRIAL REGISTRATION: Chinese Clinical Trial Registry (Registration No. ChiCTR2400084075); Date of Registration: 10/05/2024.