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Trials  2011 

Prevention of abdominal wound infection (PROUD trial, DRKS00000390): study protocol for a randomized controlled trial

DOI: 10.1186/1745-6215-12-245

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Abstract:

The PROUD trial is designed as a randomised, controlled, observer, surgeon and patient blinded multicenter superiority trial with two parallel groups and a primary endpoint of wound infection during 30 days after surgery. The intervention group will receive triclosan coated polydioxanone sutures, whereas the control group will receive the standard polydioxanone sutures; abdominal closure will otherwise be standardized in both groups. Statistical analysis is based on intention-to-treat population via binary logistic regression analysis, the total sample size of n = 750 is sufficient to ensure alpha = 5% and power = 80%, an interim analysis will be carried out after data of 375 patients are available.The PROUD trial will yield robust data to determine the effectiveness of antibacterial coating in one of the standard sutures for abdominal closure and potentially lead to amendment of current guidelines. The exploration of clinically objective parameters as well as quality of life holds immediate relevance for clinical management and the pragmatic trial design ensures high external validity.The trial protocol has been registered with the German Clinical Trials Register (DRKS00000390).Postoperative surgical site infections (SSI) are one of the most common complications after laparotomy. Many strategies have been developed to reduce this burden such as the introduction of less invasive procedures (e.g. laparoscopic interventions) but still most of the intraabdominal procedures are performed as open surgeries worldwide. Preoperative antibiotic prophylaxis besides routine use of effective and persistent skin antisepsis as well as avoidance and/or control of contamination were amongst the most effective interventions introduced in the last century to reduce SSI.Currently about 12% of patients undergoing elective open colorectal procedures develop an SSI [1]. This is in accordance with the "Hospital in Europe Link for Infection Control through Surveillance" (HELICS) SSI statis

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