Examination of the Effect of Skin Antisepsis With Pre-heated Povidone Iodine on Surgical Site Infections: A Quasi-Experimental Study

Surgical Site Infections Clinical Trial

Official title:

Examination of the Effect of Skin Antisepsis With Pre-heated Povidone Iodine on Surgical Site Infections: A Quasi-Experimental Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04969302
• Other study ID #: 19/21
• Status: Completed
• Phase: N/A
• Start date: September 28, 2021
• Est. completion date: July 28, 2022

Study information

• Verified date: October 2022
• Source: Eastern Mediterranean University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: July 28, 2022
• Est. primary completion date: December 28, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Being 18 years or older

• Having undergone abdominal surgery

• Volunteering to participate in the research

• Patients without risk of preoperative malnutrition

Exclusion Criteria:

• Those who test positive for known Povidone Iodine allergy

• Those who use steroids and immunosuppressive drugs

• Those who used antibiotics due to infection in the last two weeks (prophylactic antibiotic use is not included in this item since all patients were given antibiotics for prophylaxis on the first day before surgery)

• Those diagnosed with Diabetes Mellitus (DM)

• Obese (BMI>30) patients

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Surgical Site Infections
• Surgical Wound Infection

Intervention

Diagnostic Test:
• Follow-up
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

Locations

Country	Name	City	State
Cyprus	Eastern Mediterranean University	Famagusta

Sponsors (1)

Lead Sponsor	Collaborator
Eastern Mediterranean University

Country where clinical trial is conducted

Cyprus, 

References & Publications (5)

Gezer S, Yalvaç HM, Güngör K, Yücesoy I. Povidone-iodine vs chlorhexidine alcohol for skin preparation in malignant and premalignant gynaecologic diseases: A randomized controlled study. Eur J Obstet Gynecol Reprod Biol. 2020 Jan;244:45-50. doi: 10.1016/j — View Citation

Leaper DJ, Edmiston CE. World Health Organization: global guidelines for the prevention of surgical site infection. J Hosp Infect. 2017 Feb;95(2):135-136. doi: 10.1016/j.jhin.2016.12.016. Epub 2016 Dec 24. — View Citation

Rogers SO Jr. Surgical Perspective: Centers for Disease Control and Prevention Guideline for the Prevention of Surgical Site Infection 2017. Surg Infect (Larchmt). 2017 May/Jun;18(4):383-384. doi: 10.1089/sur.2017.097. — View Citation

Wistrand C, Nilsson U. Effects and experiences of warm versus cold skin disinfection. Br J Nurs. 2011 Feb 10-23;20(3):148,150-1. — View Citation

Wistrand C, Söderquist B, Nilsson U. Positive impact on heat loss and patient experience of preheated skin disinfection: a randomised controlled trial. J Clin Nurs. 2016 Nov;25(21-22):3144-3151. doi: 10.1111/jocn.13263. Epub 2016 Jun 3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	30 days
Secondary	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	30 days