BJA Open. 2025 Apr 10;14:100396. doi: 10.1016/j.bjao.2025.100396. eCollection 2025 Jun.
Infections are a common complication of abdominal surgery in low- and middle-income countries (LMICs). The role of a high fraction of inspired oxygen (FiO) and chlorhexidine mouthwash in preventing post-operative infections is unconfirmed.
Internal pilot phase of an international outcome assessor-blinded, 2x2 factorial randomised trial of patients aged ≥10-years undergoing midline laparotomy in LMIC hospitals. The main trial objectives are to compare the clinical effectiveness of preoperative 0.2% chlorhexidine mouthwash in preventing pneumonia versus no mouthwash, and 80-100% perioperative FiO to prevent surgical site infection (SSI) versus 21-35% FiO. This 12-month internal pilot assessed feasibility of hospital site opening, patient recruitment, intervention adherence, patient follow-up and safety. Patients were randomised in a 1:1:1:1 ratio to the four intervention group combinations and followed up for 30 days.
We recruited 927 patients from seven hospitals in India and South Africa over 12 months from November 2020. There were 907 adults (97.8%) and 20 children aged ten or over (2.2%): 89/927 (9.6%) patients died. Site opening reached 70% of our target (7/10) hospitals, and patient recruitment 107% (927/870). 917/927 (99%) patients in the mouthwash arm, and 840/927 (91%) patients in the oxygen arm received the allocated intervention. Lower adherence to the oxygen intervention related mainly to clinically necessary FiO increases in the 21-35% FiO arm. 30-day follow-up was completed appropriately for 924/927 (99%) patients. and was performed by a masked assessor for all patients. There were no reported safety events.
This pilot showed the feasibility and safety of a major phase III trial in post-operative infection prevention in LMICs.
ClinicalTrials.gov NCT04256798.
在低收入和中等收入国家（LMICs），感染是腹部手术常见的并发症。高浓度吸氧（FiO）和洗必泰漱口水在预防术后感染中的作用尚未得到证实。
一项国际结局评估者设盲的2×2析因随机试验的内部试点阶段，该试验针对年龄≥10岁、在LMICs医院接受中线剖腹手术的患者。主要试验目标是比较术前0.2%洗必泰漱口水与不使用漱口水预防肺炎的临床效果，以及80-100%围手术期FiO与21-35%FiO预防手术部位感染（SSI）的临床效果。这项为期12个月的内部试点评估了医院开放、患者招募、干预依从性、患者随访和安全性的可行性。患者按1:1:1:1的比例随机分配到四种干预组组合中，并随访30天。
从2020年11月起的12个月内，我们从印度和南非的七家医院招募了927名患者。有907名成年人（97.8%）和20名10岁及以上儿童（2.2%）：89/927（9.6%）名患者死亡。医院开放率达到了我们目标（10家）医院的70%（7家），患者招募率达到了107%（927/870）。漱口水组917/927（99%）的患者和吸氧组840/927（91%）的患者接受了分配的干预。吸氧干预的依从性较低，主要与21-35%FiO组临床上必要的FiO增加有关。924/927（99%）的患者完成了30天的适当随访，所有患者均由设盲评估者进行随访。没有报告的安全事件。
该试点表明了在LMICs预防术后感染的大型III期试验的可行性和安全性。
ClinicalTrials.gov NCT04256798。
