search
Back to results

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

Primary Purpose

Surgical Site Infections

Status
Completed
Phase
Not Applicable
Locations
Cyprus
Study Type
Interventional
Intervention
Follow-up
Sponsored by
Eastern Mediterranean University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Surgical Site Infections focused on measuring Povidone Iodine, Skin antisepsis, Abdominal Surgery

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Eastern Mediterranean University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention Group

Control Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
June 26, 2021
Last Updated
October 18, 2022
Sponsor
Eastern Mediterranean University
search

1. Study Identification

Unique Protocol Identification Number
NCT04969302
Brief Title
Examination of the Effect of Skin Antisepsis With Pre-heated Povidone Iodine on Surgical Site Infections: A Quasi-Experimental Study
Official Title
Examination of the Effect of Skin Antisepsis With Pre-heated Povidone Iodine on Surgical Site Infections: A Quasi-Experimental Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
September 28, 2021 (Actual)
Primary Completion Date
December 28, 2021 (Actual)
Study Completion Date
July 28, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Eastern Mediterranean University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Site Infections
Keywords
Povidone Iodine, Skin antisepsis, Abdominal Surgery

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
124 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Follow-up
Intervention Description
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
Primary Outcome Measure Information:
Title
Surgical Site Infection Follow-up Form
Description
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
Secondary Outcome Measure Information:
Title
Discharge Follow-up
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kerem Yıldız, PhD Student
Organizational Affiliation
Eastern Mediterranean University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Eastern Mediterranean University
City
Famagusta
Country
Cyprus

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
28139389
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. No abstract available.
Results Reference
background
PubMed Identifier
28541803
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. No abstract available.
Results Reference
background
PubMed Identifier
31739120
Citation
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.
Results Reference
result
PubMed Identifier
27256458
Citation
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.
Results Reference
result
PubMed Identifier
21378634
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. doi: 10.12968/bjon.2011.20.3.148.
Results Reference
result

Learn more about this trial

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

We'll reach out to this number within 24 hrs