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Comparison of Two Preoperative Antiseptic Solutions Alcohol Based in Abdominal Elective Surgeries

Primary Purpose

Surgical Site Infection

Status
Terminated
Phase
Phase 4
Locations
El Salvador
Study Type
Interventional
Intervention
Iodine Povacrylex 7 MG/ML / Isopropyl Alcohol 0.74 ML/ML
Chlorhexidine Gluconate 20 MG/ML / Isopropyl Alcohol 0.7 ML/ML
Sponsored by
Universidad de El Salvador
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Surgical Site Infection focused on measuring surgery, infection, antisepsis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Elective surgery categorized as clean contaminated surgery Major abdominal

-

Exclusion Criteria:

  • American Society of Anesthesia III-IV
  • Laparoscopic cholecystectomy
  • Inguinal hernias classification I, II
  • Obese subjects with Body Mass Index more than 35 or malnourished
  • immunocompromised subjects
  • neoplasia Preoperative hospital stay more than 7 days allergic to any of the solutions used in the trial

Sites / Locations

  • Hospital Nacional Rosales

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Iodine-Povacrylex Alcohol

Chlorhexidine Alcohol

Arm Description

Iodine Povacrylex 7 MG/ML / Isopropyl Alcohol 0.74 ML/ML: preoperative asepsis with subject already lying down in the operating room, already with anesthesia, before dressing and incision, with single dose applicator of Iodine-povacrylex 7mg/ml plus isopropyl alcohol 0.74 ml/ml (DuraPrep) , fabricated by 3M, as the experimental intervention. Will be applied from the center of the abdomen centrifuge as recommended by the Centers of Disease Control

Chlorhexidine Gluconate 20 MG/ML / Isopropyl Alcohol 0.7 ML/ML: preoperative asepsis with subject already lying down in the operating room, already with anesthesia, before dressing and incision, with single dose applicator of chlorhexidine 20 mg/ml plus isopropyl alcohol 0.7 ml/ml (SoluPrep), fabricated by 3M, as the control intervention. Will be applied from the center of the abdomen centrifuge as recommended by the Center of Disease Control

Outcomes

Primary Outcome Measures

Surgical site infection
infections of the incision or organ or space that occur after surgery.

Secondary Outcome Measures

Superficial surgical site infection
Infection that occurs after surgery and involves only skin and subcutaneous tissue of the incision
Deep surgical site infection
Infection that occurs after surgery that involves deep soft tissues of the incision (for example, fascial and muscle layers)
Organ/space SSI
Infection that occurs after surgery that involves any part of the body deeper than the fascial/muscle layers that is opened or manipulated during the operative procedure
Skin reaction
Any kind of irritation or skin reaction after applying the solution

Full Information

First Posted
February 26, 2019
Last Updated
May 8, 2023
Sponsor
Universidad de El Salvador
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1. Study Identification

Unique Protocol Identification Number
NCT03859908
Brief Title
Comparison of Two Preoperative Antiseptic Solutions Alcohol Based in Abdominal Elective Surgeries
Official Title
Iodine-Povidone Alcohol Compared to Chlorhexidine Alcohol as Preoperative Antiseptics in Major Abdominal Elective Clean Contaminated Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Terminated
Why Stopped
Difficulties for recruitment due to COVID-19 pandemia and expiration of the material
Study Start Date
April 5, 2019 (Actual)
Primary Completion Date
January 27, 2021 (Actual)
Study Completion Date
January 27, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de El Salvador

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Pragmatic randomized clinical trial comparing Iodine Povacrylex based on alcohol to Chlorhexidine also based on alcohol in efficacy and security to diminish frequency of surgical site infections in major abdominal elective clean contaminated wounds. Will be held in a third level university, high volume national public hospital in San Salvador, El Salvador.
Detailed Description
Preoperative antiseptic Chlorhexidine based on alcohol has been established as gold standard of care for clean contaminated wounds. It was compared to Iodine solutions non-alcohol based. There is a question about alcohol based solution was a confounder in the comparison. The aim of this study is to compare the efficacy of both solutions alcohol based, 0.7% iodine povacrylex plus 74% alcohol, against gluconate chlorhexidine 2% plus 70% alcohol, in clean contaminated wounds, in major abdominal elective surgeries, in a wider range than colorectal surgeries, Materials and methods. With a pragmatic randomized, phase 4, controlled clinical trial. Comparison of two antiseptic solutions, using manufacturer (3M) sterile appliers' for both products, Food and Drugs Agency approved. Quality of data will be assured by first training all surgeons and residents besides researchers in the study protocol for protocol compliance in subject identification, randomization moment, and follow up. There is a plan for weekly monitoring of protocol compliance, and monthly data monitoring and auditing from Faculty of Medicine Research Unit. Monitoring and auditing will comply protocol compliance and data integrity against subject's medical records and random interviews of patients in their post-surgical control. Surgical Site Infection definitions are those taken from Centers for Disease Control definitions. Standard Operating Procedures will be established in all moments of the trial, from subject identification, informed consent, recruitment, randomization process in the operating room, and data collection in pre specified files for data collection and data management. Protocol compliance and Standard Operating Procedures compliance will be monitored by Principal Investigator constantly. Report of adverse events will be done in accordance to Salvadoran National ethics committee Standard Operating Procedures as also any other communication such as protocol deviance or amendments. Previous research has not reported adverse events, but we will be expectant to their appearance. Sample size was calculated for a total of 964 subjects, 482 in each group, using statistics software, were we established a statistic significant level for a bilateral hypothesis of 95% and a power of 80%, based on previous research of comparison of both solutions to get a probability of SSI of 4.2% in Chlorhexidine group against 8.6% in Iodine povacrylex group. We will establish a strict follow up of patients in the 30 days considered as post-operative time, by enabling the whole public health system to integrate in subjects´, surgical care (primary care) to diminish the probability of missing data. Data analysis will be done following "intention to treat" analysis principle. Primary outcome will be any kind of Surgical Site Infection, categorical variable, will be analyzed with chi square for a bilateral hypothesis, and also measure the difference with risk ratio and its 95% confidence interval.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Site Infection
Keywords
surgery, infection, antisepsis

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Pragmatic, randomized controlled trial of two substances
Masking
Participant
Masking Description
Participant will be randomized through a selection of a sealed envelope with computer generated random numbers by the Operating Room nurse, and the substance will be applied when participant will be already with anesthesia
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Iodine-Povacrylex Alcohol
Arm Type
Experimental
Arm Description
Iodine Povacrylex 7 MG/ML / Isopropyl Alcohol 0.74 ML/ML: preoperative asepsis with subject already lying down in the operating room, already with anesthesia, before dressing and incision, with single dose applicator of Iodine-povacrylex 7mg/ml plus isopropyl alcohol 0.74 ml/ml (DuraPrep) , fabricated by 3M, as the experimental intervention. Will be applied from the center of the abdomen centrifuge as recommended by the Centers of Disease Control
Arm Title
Chlorhexidine Alcohol
Arm Type
Active Comparator
Arm Description
Chlorhexidine Gluconate 20 MG/ML / Isopropyl Alcohol 0.7 ML/ML: preoperative asepsis with subject already lying down in the operating room, already with anesthesia, before dressing and incision, with single dose applicator of chlorhexidine 20 mg/ml plus isopropyl alcohol 0.7 ml/ml (SoluPrep), fabricated by 3M, as the control intervention. Will be applied from the center of the abdomen centrifuge as recommended by the Center of Disease Control
Intervention Type
Drug
Intervention Name(s)
Iodine Povacrylex 7 MG/ML / Isopropyl Alcohol 0.74 ML/ML
Other Intervention Name(s)
[DuraPrep]
Intervention Description
As preoperative antiseptic, applied once as suggested by Centers for Disease Control recommendations in surgical asepsis
Intervention Type
Drug
Intervention Name(s)
Chlorhexidine Gluconate 20 MG/ML / Isopropyl Alcohol 0.7 ML/ML
Other Intervention Name(s)
SoluPrep, ChloraPrep
Intervention Description
As preoperative antiseptic, applied once as suggested by Centers for Disease Control recommendations in surgical asepsis
Primary Outcome Measure Information:
Title
Surgical site infection
Description
infections of the incision or organ or space that occur after surgery.
Time Frame
Date of event occurs within 30 days after any operative procedure (where day 1 = the procedure date)
Secondary Outcome Measure Information:
Title
Superficial surgical site infection
Description
Infection that occurs after surgery and involves only skin and subcutaneous tissue of the incision
Time Frame
Date of event occurs within 30 days after any operative procedure (where day 1 = the procedure date)
Title
Deep surgical site infection
Description
Infection that occurs after surgery that involves deep soft tissues of the incision (for example, fascial and muscle layers)
Time Frame
Date of event occurs within 30 days after any operative procedure (where day 1 = the procedure date)
Title
Organ/space SSI
Description
Infection that occurs after surgery that involves any part of the body deeper than the fascial/muscle layers that is opened or manipulated during the operative procedure
Time Frame
Date of event occurs within 30 days after any operative procedure (where day 1 = the procedure date)
Title
Skin reaction
Description
Any kind of irritation or skin reaction after applying the solution
Time Frame
Date of event occurs within 7 days after surgery (where day 1= the procedure date

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Elective surgery categorized as clean contaminated surgery Major abdominal - Exclusion Criteria: American Society of Anesthesia III-IV Laparoscopic cholecystectomy Inguinal hernias classification I, II Obese subjects with Body Mass Index more than 35 or malnourished immunocompromised subjects neoplasia Preoperative hospital stay more than 7 days allergic to any of the solutions used in the trial
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria-Virginia Rodriguez, MD, FACS
Organizational Affiliation
Universidad de El Salvador
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Nacional Rosales
City
San Salvador
ZIP/Postal Code
0000
Country
El Salvador

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
If we decide to share IPD, it will be: study protocol, statistical analysis. Criteria to share: for systematic reviews we could share also individual data collected, after the study is published. The study was stopped for recruitment due to COVID-19 emergency and elective surgeries diminished, and then the product used expired. Couldn't achieve not even 2% of Sample size

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Comparison of Two Preoperative Antiseptic Solutions Alcohol Based in Abdominal Elective Surgeries

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