Clinical trial NCT03859908: 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
Overall status: TERMINATED
Phase: PHASE4
Conditions: Surgical Site Infection
Keywords: surgery
infection
antisepsis
Lead sponsor: Universidad de El Salvador
Sponsor class: OTHER
First posted: 2019-03-01
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pragmatic, randomized controlled trial of two substances
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

Elective surgery categorized as clean contaminated surgery Major abdominal

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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

Primary outcomes:
measure: Surgical site infection
timeFrame: Date of event occurs within 30 days after any operative procedure (where day 1 = the procedure date)
Secondary outcomes:
measure: Superficial surgical site infection
timeFrame: Date of event occurs within 30 days after any operative procedure (where day 1 = the procedure date)
measure: Deep surgical site infection
timeFrame: Date of event occurs within 30 days after any operative procedure (where day 1 = the procedure date)
measure: Organ/space SSI
timeFrame: Date of event occurs within 30 days after any operative procedure (where day 1 = the procedure date)
measure: Skin reaction
timeFrame: Date of event occurs within 7 days after surgery (where day 1= the procedure date
Other outcomes:
Locations:
city: San Salvador
country: El Salvador
facility: Hospital Nacional Rosales
Study officials:
affiliation: Universidad de El Salvador
name: Maria-Virginia Rodriguez, MD, FACS
role: PRINCIPAL_INVESTIGATOR
References: