NCT04969302

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

Completed NA Last updated 19 October 2022

What this trial tests

NA trial testing Follow-up in Surgical Site Infections in 124 participants. Completed in 28 July 2022.

Timeline

28 September 2021

Primary endpoint
28 December 2021

28 July 2022

Quick facts

Lead sponsor	Eastern Mediterranean University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	screening
Enrollment	124
Start date	28 September 2021
Primary completion	28 December 2021
Estimated completion	28 July 2022
Sites	1 location across Cyprus

Drugs / interventions tested

• Follow-up

Conditions studied

• Surgical Site Infections — all drugs for Surgical Site Infections →

Sponsor

Eastern Mediterranean University

Who can join

Adults 18 to 60, any sex, with Surgical Site Infections. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Antimicrobial approach of abdominal post-surgical infections.
   Fiore M, Corrente A, Di Franco S, Alfieri A, et al · · 2023 · cited 6× · PMID 38222012 · DOI 10.4240/wjgs.v15.i12.2674