Grandis J R, Vickers R M, Rihs J D, Yu V L, Wagner R L, Kachman K K, Johnson J T
Department of Otolaryngology, University of Pittsburgh School of Medicine, Pa.
Laryngoscope. 1994 Jun;104(6 Pt 1):719-24. doi: 10.1288/00005537-199406000-00011.
This study was undertaken to determine the feasibility of using perioperative topical antibiotics in contaminated head and neck surgery and to standardize the culture methodology (both qualitative and quantitative) which could serve as bacteriologic endpoints for evaluation. Following preliminary studies to establish oral cavity indicator organisms and the impact of a single antibiotic mouthwash dose on oral microflora, 10 consecutive patients undergoing contaminated head and neck surgery were recruited into a clinical trial where clindamycin mouthwash and intraoperative irrigation containing clindamycin were used instead of traditional parenteral antibiotics. The bacteriologic efficacy of topical clindamycin was assessed by comparing the presence of four indicator microorganisms (two aerobic and two anaerobic) cultured from two oral cavity culture sites before and after antibiotic prophylaxis. The patients included in the study underwent total laryngectomy plus neck dissection(s) for laryngeal or hypopharyngeal carcinoma from 1991 to 1992 at a large university hospital specializing in head and neck cancer surgery. The main outcome measures used were the development of a postoperative wound infection and quantitative and qualitative bacteriology of the intraoperative neck wound and postoperative oral cavity. Two aerobic and two anaerobic organisms proved useful as a practical indicator for bacteriologic efficacy. Preoperative mouthwash resulted in a 99% reduction of both aerobic and anaerobic bacteria in intraoperatively cultured neck sites. Irrigation during surgery with the clindamycin solution further reduced the bacterial neck counts by an additional 90%. There was a consistent overgrowth of Hemophilus species on postoperative oral cavity cultures. No patient developed a postoperative wound infection. A topical prophylactic antibiotic alone was efficacious and safe for patients undergoing major contaminated head and neck surgery. Culture methods for assessment of bacteriologic efficacy were reproducible and cost-effective. This pilot study furnishes the ethical and scientific basis for large-scale prospective trials comparing topical versus parenteral antimicrobial agents.
本研究旨在确定在污染的头颈外科手术中使用围手术期局部抗生素的可行性，并规范可作为评估细菌学终点的培养方法（包括定性和定量）。在进行初步研究以确定口腔指示菌以及单次抗生素漱口水剂量对口腔微生物群的影响之后，连续招募了10例接受污染头颈外科手术的患者进入一项临床试验，试验中使用克林霉素漱口水和含克林霉素的术中冲洗液替代传统的胃肠外抗生素。通过比较预防性使用抗生素前后从两个口腔培养部位培养出的四种指示微生物（两种需氧菌和两种厌氧菌）的存在情况，评估局部使用克林霉素的细菌学疗效。1991年至1992年，在一家专门从事头颈癌手术的大型大学医院，纳入研究的患者因喉癌或下咽癌接受了全喉切除术加颈部清扫术。主要的观察指标包括术后伤口感染的发生情况以及术中颈部伤口和术后口腔的定量和定性细菌学检查。两种需氧菌和两种厌氧菌被证明是评估细菌学疗效的实用指示菌。术前漱口水使术中培养的颈部部位的需氧菌和厌氧菌数量均减少了99%。术中用克林霉素溶液冲洗进一步使颈部细菌数量额外减少了90%。术后口腔培养中嗜血杆菌属持续过度生长。没有患者发生术后伤口感染。单独使用局部预防性抗生素对接受重大污染头颈外科手术的患者有效且安全。评估细菌学疗效的培养方法具有可重复性且成本效益高。这项初步研究为比较局部与胃肠外抗菌药物的大规模前瞻性试验提供了伦理和科学依据。
