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

NCT03859908 | Terminated Phase 4 DMC FDA Drug

• 2 other identifiers: Iodine alcohol TrialCNEIS/2018/049
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgical Site Infection

Keywords

surgery; infection; antisepsis

Outcome Measures

Primary Outcomes (1)

• Surgical site infection

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

  Date of event occurs within 30 days after any operative procedure (where day 1 = the procedure date)

Secondary Outcomes (4)

• Superficial surgical site infection

  Date of event occurs within 30 days after any operative procedure (where day 1 = the procedure date)

• Deep surgical site infection

  Date of event occurs within 30 days after any operative procedure (where day 1 = the procedure date)

• Organ/space SSI

  Date of event occurs within 30 days after any operative procedure (where day 1 = the procedure date)

• Skin reaction

  Date of event occurs within 7 days after surgery (where day 1= the procedure date

Study Arms (2)

Iodine-Povacrylex Alcohol

EXPERIMENTAL

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

Drug: Iodine Povacrylex 7 MG/ML / Isopropyl Alcohol 0.74 ML/ML

Chlorhexidine Alcohol

ACTIVE COMPARATOR

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

Drug: Chlorhexidine Gluconate 20 MG/ML / Isopropyl Alcohol 0.7 ML/ML

Interventions

Iodine Povacrylex 7 MG/ML / Isopropyl Alcohol 0.74 ML/ML DRUG

As preoperative antiseptic, applied once as suggested by Centers for Disease Control recommendations in surgical asepsis

Also known as: [DuraPrep]

Iodine-Povacrylex Alcohol

Chlorhexidine Gluconate 20 MG/ML / Isopropyl Alcohol 0.7 ML/ML DRUG

As preoperative antiseptic, applied once as suggested by Centers for Disease Control recommendations in surgical asepsis

Also known as: SoluPrep, ChloraPrep

Chlorhexidine Alcohol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Elective surgery categorized as clean contaminated surgery Major abdominal

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad de El Salvador: lead

Study Sites (1)

Hospital Nacional Rosales

San Salvador, 0000, El Salvador

Location

MeSH Terms

Conditions

Surgical Wound Infection; Infections

Interventions

2-Propanol; DuraPrep; chlorhexidine gluconate

Condition Hierarchy (Ancestors)

Wound Infection; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Propanols; Alcohols; Organic Chemicals

Study Officials

• Maria-Virginia Rodriguez, MD, FACS

  Universidad de El Salvador

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical research coordinator

Model Details: Pragmatic, randomized controlled trial of two substances

Study Record Dates

• First Submitted: February 26, 2019
• First Posted: March 1, 2019
• Study Start: April 5, 2019
• Primary Completion: January 27, 2021
• Study Completion: January 27, 2021
• Last Updated: May 10, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

EL (1)