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

NCT04969302 | Completed

• 1 other identifier: 19/21
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Surgical Site Infections

Keywords

Povidone Iodine; Skin antisepsis; Abdominal Surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Discharge Follow-up

  30 days

Study Arms (2)

Intervention Group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

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.

Interventions

Follow-up DIAGNOSTIC_TEST

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

Intervention Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Being 18 years or older
• Having undergone abdominal surgery
• Volunteering to participate in the research
• Patients without risk of preoperative malnutrition

You may not qualify if:

• 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

Sponsors & Collaborators

• Eastern Mediterranean University: lead

Study Sites (1)

Eastern Mediterranean University

Famagusta, Cyprus

Location

Related Publications (5)

• 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. No abstract available.

  PMID: 28139389 BACKGROUND

• 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. No abstract available.

  PMID: 28541803 BACKGROUND

• Gezer S, Yalvac HM, Gungor K, Yucesoy 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.ejogrb.2019.10.035. Epub 2019 Nov 9.

  PMID: 31739120 RESULT

• Wistrand C, Soderquist 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.

  PMID: 27256458 RESULT

• 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. doi: 10.12968/bjon.2011.20.3.148.

  PMID: 21378634 RESULT

MeSH Terms

Conditions

Surgical Wound Infection

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Kerem Yıldız, PhD Student

  Eastern Mediterranean University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 26, 2021
• First Posted: July 20, 2021
• Study Start: September 28, 2021
• Primary Completion: December 28, 2021
• Study Completion: July 28, 2022
• Last Updated: October 19, 2022

Record last verified: 2022-10

Locations

CY (1)