Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04969302
Other study ID # 19/21
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
See also
  Status Clinical Trial Phase
Completed NCT02253069 - PHMB-based Antiseptic Use in Full-thickness Surgical Wounds N/A
Completed NCT01472549 - The Skin Prep Study N/A
Completed NCT03685604 - PVP Iodine vs Chlorhexidine in Alcohol for Disinfection of the Surgical Site Phase 4
Not yet recruiting NCT02503904 - Tumescent Antibiotic Delivery for Prevention of Surgical Site Infection Phase 2/Phase 3
Completed NCT01888367 - Safety, Efficacy and Tolerability Study of up to 20 mL of DFA-02 in Patients Undergoing Abdominal Surgery Phase 2
Completed NCT02619773 - Effect of Mupirocin Dressings Versus Island Dressings on Surgical Site Infections in Elective Colorectal Surgery N/A
Completed NCT01425697 - Eliminate Risk of Cardiac Surgical Site Events N/A
Terminated NCT02799667 - Do Single Use Negative Pressure Dressings Reduce Wound Complications in Obese Women After Cesarean Delivery N/A
Recruiting NCT02436395 - Povidone-iodine and the Normal Saline Cleaning the Incision for the SSIs N/A
Active, not recruiting NCT03402945 - Prevention of Infections in Cardiac Surgery (PICS) Prevena Study Phase 4
Withdrawn NCT02666365 - Continuous v Bolus Infusion of Cefazolin During Ventral Hernia Repair Phase 4
Completed NCT01971138 - Review of Surgical Site Infection Registration Routine at Surgery Departments in Sweden and Validation of One of the Used Routines N/A
Completed NCT01949935 - Efficacy Study of Mupirocin on Infection After Coronary Artery Bypass Grafting Phase 3
Completed NCT01138852 - Ampicillin/Sulbactam Versus Cefuroxime as Antimicrobial Prophylaxis for Cesarean Section Phase 4
Recruiting NCT06378359 - Effectiveness of Screening and Decolonization of S. Aureus to Prevent S. Aureus Surgical Site Infections in Surgery Outpatients
Not yet recruiting NCT02012517 - Antibiotic Prophylaxis in Prosthetic Breast Reconstructions Phase 4
Completed NCT01916733 - A Quality Initiative to Improve Glycemic Control in Diabetic and Non-Diabetic Insulin Study N/A
Completed NCT03686553 - St. Barbara Specialised Regional Hospital No. 5: Surveillance of Healthcare-Associated Infections
Not yet recruiting NCT06043414 - Barbed Suture vs Non-Barbed Closure for Emergency Exploratory Laparotomy RCT N/A
Completed NCT05090657 - Nasal Photodisinfection in All Patients Presenting for Surgery for a Wide Range of Surgical Procedures Phase 2