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

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ClinicalTrials.gov Identifier: NCT03859908
Recruitment Status : Recruiting
First Posted : March 1, 2019
Last Update Posted : April 9, 2019
Sponsor:
Information provided by (Responsible Party):
Maria-Virginia Rodriguez Funes, Universidad de El Salvador

Tracking Information
First Submitted Date  ICMJE February 26, 2019
First Posted Date  ICMJE March 1, 2019
Last Update Posted Date April 9, 2019
Actual Study Start Date  ICMJE April 5, 2019
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 26, 2019)
Surgical site infection [ Time Frame: Date of event occurs within 30 days after any operative procedure (where day 1 = the procedure date) ]
infections of the incision or organ or space that occur after surgery.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 26, 2019)
  • Superficial surgical site infection [ Time Frame: Date of event occurs within 30 days after any operative procedure (where day 1 = the procedure date) ]
    Infection that occurs after surgery and involves only skin and subcutaneous tissue of the incision
  • Deep surgical site infection [ Time Frame: Date of event occurs within 30 days after any operative procedure (where day 1 = the procedure date) ]
    Infection that occurs after surgery that involves deep soft tissues of the incision (for example, fascial and muscle layers)
  • Organ/space SSI [ Time Frame: Date of event occurs within 30 days after any operative procedure (where day 1 = the procedure date) ]
    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 [ Time Frame: Date of event occurs within 7 days after surgery (where day 1= the procedure date ]
    Any kind of irritation or skin reaction after applying the solution
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Two Preoperative Antiseptic Solutions Alcohol Based in Abdominal Elective Surgeries
Official Title  ICMJE Iodine-Povidone Alcohol Compared to Chlorhexidine Alcohol as Preoperative Antiseptics in Major Abdominal Elective Clean Contaminated Surgery
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Pragmatic, randomized controlled trial of two substances
Masking: Single (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
Primary Purpose: Prevention
Condition  ICMJE Surgical Site Infection
Intervention  ICMJE
  • Drug: Iodine Povacrylex 7 MG/ML / Isopropyl Alcohol 0.74 ML/ML
    As preoperative antiseptic, applied once as suggested by Centers for Disease Control recommendations in surgical asepsis
    Other Name: [DuraPrep]
  • Drug: Chlorhexidine Gluconate 20 MG/ML / Isopropyl Alcohol 0.7 ML/ML
    As preoperative antiseptic, applied once as suggested by Centers for Disease Control recommendations in surgical asepsis
    Other Names:
    • SoluPrep
    • ChloraPrep
Study Arms  ICMJE
  • Experimental: Iodine-Povacrylex Alcohol
    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
    Intervention: Drug: Iodine Povacrylex 7 MG/ML / Isopropyl Alcohol 0.74 ML/ML
  • Active Comparator: Chlorhexidine Alcohol
    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: Drug: Chlorhexidine Gluconate 20 MG/ML / Isopropyl Alcohol 0.7 ML/ML
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 26, 2019)
964
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2021
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Maria-Virginia Rodriguez, MD, FACS +50371902009 rodriguezvir_cirug@yahoo.com.mx
Listed Location Countries  ICMJE El Salvador
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03859908
Other Study ID Numbers  ICMJE Iodine alcohol Trial
CNEIS/2018/049 ( Other Identifier: Comite Nacional de Etica de Investigacion en Salud )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
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
Responsible Party Maria-Virginia Rodriguez Funes, Universidad de El Salvador
Study Sponsor  ICMJE Universidad de El Salvador
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Maria-Virginia Rodriguez, MD, FACS Universidad de El Salvador
PRS Account Universidad de El Salvador
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP