Trial reportTrials2017
Intraoperative wound irrigation to prevent surgical site infection after laparotomy (IOWISI): study protocol for a randomized controlled trial.
Trial report in Trials, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
8 citing papers in PubMed, 22 citations in OpenAlex.
- [Resource conservation from the perspective of infection prevention].Chirurgie (Heidelberg, Germany) · 2023Review
- Article
- Intraoperative incision irrigation with high-volume saline reduces surgical site infection for abdominal infections.Frontiers in surgery · 2022Article
- The clinical effect of nursing intervention in the operating room on the prevention of orthopedic wound infections.American journal of translational research · 2021Article
- The role of saline irrigation prior to wound closure in the reduction of surgical site infection: a systematic review and meta-analysis.Patient safety in surgery · 2020Review
- Short-Term Postoperative Outcomes between 4% Icodextrin Solution and Hyaluronic Acid- Carboxymethyl Cellulose Membrane during Emergency Cesarean Section.Journal of clinical medicine · 2019Article
- Current status of postoperative infections after digestive surgery in Japan: The Japan Postoperative Infectious Complications Survey in 2015.Annals of gastroenterological surgery · 2019Article
- Effect of Wound Irrigation with Povidone Iodine Versus Normal Saline on Superficial Incisional Surgical Site Infection Following Laparotomy for Peritonitis.Journal of the West African College of SurgeonsArticle
Corrections and comments
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Authors and funding
9 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundPostoperative surgical site infection (SSI) is one of the most common hospital infections and contributes substantially to postoperative morbidity and mortality. In addition, SSIs dramatically increase the treatment cost and length of hospital stay. Following visceral surgery by laparotomy, SSI rates are especially high (14-25%). Therefore, measures to prevent SSI in this field are urgently needed. Prophylactic intraoperative wound irrigation (IOWI) of the subcutaneous soft tissue before skin closure hypothetically represents an easy and economical option to reduce SSI rates and is already frequently used in clinical practice. However, there are currently no definite recommendations on the use of IOWI since high-level evidence supporting its use is lacking. Consequently, clinical practice varies widely. Antiseptic polyhexanide (PHX)-based solutions are approved for soft-tissue wound irrigation in surgery but have not been specifically evaluated in randomized clinical trials for the prevention of SSI following laparotomy for visceral surgery. METHODS/
designThe IOWISI trial is a multicentre, randomized, observer- and patient-blinded clinical trial with three parallel treatment groups, comparing IOWI with a 0.04% PHX solution to no irrigation (test 1) or saline (test 2) before skin closure after laparotomy for visceral surgery (contamination level II-IV). The primary endpoint of the trial is the SSI rate within 30 days postoperatively. Statistical analysis of the primary endpoint measure will be based on the intention-to-treat population. The global level of significance is set at 2.5% for test 1 and 5% for test 2 and the sample size (n = 540) is determined to assure a power of 94% (test 1) and 85% (test 2). DISCUSSION: The IOWISI trial will provide high-level evidence as a basis for clinical recommendations regarding the use of IOWI with PHX or saline and will potentially impact on future clinical guidelines and practice. The pragmatic trial design guarantees high external validity.
trial registrationRegistered at the German Clinical Trials Register, DRKS00012251 . Registered on 3 July 2017.
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