An interventional study of Follow-up in Surgical Site Infections, sponsored by Eastern Mediterranean University. Completed at 1 site in Cyprus. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-10-19.
Sponsored by Eastern Mediterranean University · Not applicable, Interventional, and Screening
Surgical Site Infections (SSI) develop as a complication of surgical care 30-90 days after surgery without implants and within 1 year after implanted operations. Despite advances in asepsis practices, sterilization methods, surgical technique and antibiotic prophylaxis, SSI is the most important cause of hospital stay, morbidity and even mortality. SSI, which constitutes approximately 20% of healthcare associated infections (HAI) all over the world, is also the HAI with the highest cost. Although it has been reported that 60% of the SSI can be prevented by using evidence-based guidelines, 2-5% of the operated patients develop SSI, the hospital stay of patients with SSI is 7-11 days longer, the risk of death increases 2-11 times, It was reported that the cause of death was direct SSI. In the United States of America (USA), SSI constitutes 31% of HAI, it is seen in 2-5% of inpatients, approximately 160,000-300,000 SSIs occur each year, the most common and costly HAI.Abdominal surgery; It includes the treatment of diseases of organs such as stomach, gall bladder, pancreas, spleen, liver, small intestine and large intestine. It has been reported that the incidence of SSIs after abdominal surgery is 15-25% higher than other types of surgery. In a study conducted by Alcan et al. (2020), 69.8% of nurses stated that they used Povidone Iodine as skin antisepsis. Wistrand et al. (2015) compared preoperative 36 ° C and room temperature 20 ° C Chlorhexidine Gluconate solutions, but reported that there was no difference in bacterial colonization and SSI rates. In their study in Turkey, Gezer et al. (2020) reported that the prevalence of SSI was significantly lower in the Povidone Iodine group heated to 37 ° C before surgery compared to the Povidone Iodine group applied at 25 ° C room temperature.
This study was planned in accordance with a single blind randomized controlled full experimental study design to determine the effect of skin antisepsis with Povidone Iodine, which was heated at 37°C and at a room temperature of 20°C in the preoperative period, in reducing surgical site infections in patients who underwent abdominal surgery. Patients who will undergo abdominal surgery at Dr. Burhan Nalbantoğlu State Hospital will comprise the sample of volunteer patients who meet the inclusion criteria and agree to participate in the study. The data of the study was planned to be collected using the Patient Information Form, Surgical Site Infection Follow-up Form and Post Discharge Patient Follow-up Form.
687 studies on the registry are indexed under Surgical Wound Infection; 142 are open to participants now.
This study's enrollment of 124 is below the median of 200 across 526 interventional studies indexed under Surgical Wound Infection.
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Exclusion Criteria:
Skin preparations will performe using Povidone 10% 1000 mL solution (Turkuaz Chemistry, İstanbul, Turkey) Povidone-iodine will heat to 37°C using a gel warmer (KGW-1 Keewell Medical Technology, Foshen, China) in the warm group. The day before the operation, the patient will be met and informed about the study and verbal and written consent will be obtained stating that they are willing to participate in the study. The weight tracking of the patients will be determined using a digital weight meter provided by the researcher. Patient evaluation will be made with NRS-2002 in terms of malnutrition risk. Antibiotic prophylaxis of 1000 mg available in the operating room will be administered 30-60 minutes before the operation. Before the incision, a wound culture sample will be taken with sterile transport swap and sent to the laboratory for culture study.
Diagnostic Test: Follow-up
Skin preparations will performe using Povidone 10% 1000 mL solution (Turkuaz Chemistry, İstanbul, Turkey) Povidone-iodine will heat to 20°C using a gel warmer (KGW-1 Keewell Medical Technology, Foshen, China) in the room heat group. The day before the operation, the patient will be met and informed about the study and verbal and written consent will be obtained stating that they are willing to participate in the study. The weight tracking of the patients will be determined using a digital weight meter provided by the researcher. Patient evaluation will be made with NRS-2002 in terms of malnutrition risk. Antibiotic prophylaxis of 1000 mg available in the operating room will be administered 30-60 minutes before the operation. Before the incision, a wound culture sample will be taken with sterile transport swap and sent to the laboratory for culture study.
The primary outcome of this study was SSI within 30 days of surgery, as defined by the Centers for Disease Control and Prevention. Secondary outcomes were identification of the causative organism, and investigation of clinical factors such as body mass index (BMI), operation time, days of hospitalization, etc. that may be associated with SSI. All patients were followed up for SSI until discharge from hospital and at the outpatient visits. SSI surveillance data forms were used for the collection of primary and secondary outcome data. SSI rates and distribution of identified micro-organisms for each group will measured
Surgical Site Infection Follow-up Form
The primary outcome of this study was SSI within 30 days of surgery, as defined by the Centers for Disease Control and Prevention. Secondary outcomes were identification of the causative organism, and investigation of clinical factors such as body mass index (BMI), operation time, days of hospitalization, etc. that may be associated with SSI.
Time frame: 30 days
Discharge Follow-up
All patients were followed up for SSI until discharge from hospital and at the outpatient visits. SSI surveillance data forms were used for the collection of primary and secondary outcome data. SSI rates and distribution of identified micro-organisms for each group will measured
Time frame: 30 days
Plan to share: Undecided
This study is completed, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.
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