Digestive System Diseases

All Conditions

Neoplasms

Symptoms and General Pathology

Gastroesophageal Reflux

Adenocarcinoma

Esophagitis

Barrett Esophagus

Esophagitis, Peptic

Esophageal Diseases

Gastrointestinal Diseases

Gastroenteritis

Precancerous Conditions

Ulcer

Peptic Ulcer

Duodenal Diseases

Intestinal Diseases

Stomach Diseases

Anti-Infective Agents

All Drugs and Chemicals

Dermatologic Agents

Anti-Bacterial Agents

Chlorhexidine

Chlorhexidine gluconate

Anti-Infective Agents, Local

Disinfectants

Subjects will be randomized to twice daily chlorhexidine gluconate mouthwash for 21 days.

Subjects will be randomized to no intervention for 21 days.

Chlorhexidine gluconate is a germicidal mouthwash that reduces bacteria in the mouth.

Julian A. Abrams, MD, MS

This is a randomized, open-label pilot study to assess whether treatment with chlorhexidine mouthwash can alter the esophageal and gastric cardia microbiome

Patients scheduled for upper endoscopy for clinical indications will be randomized to 3 weeks of either no treatment or use of twice daily chlorhexidine mouthwash leading up to the endoscopy. There will be 2-3 study visits, at Day 0 and Day 21, and for those subjects in the mouthwash arm, a final visit 1-2 weeks following the Day 21 visit. Subjects will be required to fast overnight prior to the visits on Days 0 and 21.

Trial to Assess the Effects of an Antimicrobial Mouthwash on the Esophageal Microbiome

Pilot Randomized Trial to Assess the Effects of an Antimicrobial Mouthwash on the Esophageal and Gastric Microbiome

Within individual change in relative abundance of F nucleatum in oral samples

Comparison of relative abundance of esophageal F. nucleatum in the mouthwash group vs. the no intervention group.

Columbia University

Participants were instructed to report any side effects of chlorhexidine. Tooth discoloration (a possible side effect of chlorhexidine use) was assessed by a dentist using photographs. The dentist was blinded to whether the images were from pre- or post-treatment.

Subjects will be randomized to twice daily chlorhexidine gluconate mouthwash for 21 days.

Chlorhexidine gluconate: Chlorhexidine gluconate is a germicidal mouthwash that reduces bacteria in the mouth.

Antibacterial Mouthwash

No Intervention

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

United States

Region of Enrollment

Proton Pump Inhibitor (PPI) Use

Aspirin Use

Ever Smoker

Gastroesophageal Reflux Disease (GERD) History

Body Mass Index

Waist to Hip Ratio (WHR)

Fat Intake

Fiber intake

Indication for Upper Endoscopy (EGD)

Endoscopic Findings

There were no indications for repeated endoscopies, so the analysis of the esophagus was limited to a single point in time; relatively small sample size.

Julian A Abrams, MD

Data was not collected and analyzed for F. Nucleatum in particular, instead an analysis was done for the microbiome composition across sample sites - oral swab, saliva and esophageal.

Reduction of F. Nucleatum in Saliva

Difference in Esophageal F. Nucleatum Between Experimental Group and no Intervention Group

Overall Study

Infections

Wounds and Injuries

Communicable Diseases

Liver Neoplasms

Surgical Wound Infection

Surgical Wound

Wound Infection

Postoperative Complications

Gastrointestinal Neoplasms

Digestive System Neoplasms

Liver Diseases

Pharmaceutical Solutions

Blood Substitutes

Hematinics

Central Nervous System Depressants

Micronutrients

Povidone-Iodine

Povidone

Liver Extracts

Ethanol

Iodine

Cadexomer iodine

(i)a sterile washcloth was saturated with 60ml of chlorhexidine gluconate (4%) cleansing solution and generously applied to the predefined surgical site followed by vigorous scrubbing for 3 min. (ii) after being patted with a sterile towel, the standardized 3-step disinfection was performed (iii) the applied iodine-alcohol disinfectant contained 70 ml of ethyl alcohol and 10 g of povidone-iodine per 100 ml

(i)a sterile washcloth was saturated with 60ml of sodium chloride (0.9%) and generously applied to the predefined surgical site followed by vigorous scrubbing for 3 min. (ii) after being patted with a sterile towel, the standardized 3-step disinfection was performed (iii) the applied iodine-alcohol disinfectant contained 70 ml of ethyl alcohol and 10 g of povidone-iodine per 100 ml

0.9% Sodium Chloride

YaoLi Chen, MD

To test whether pre - disinfection skin scrub with 4% chlorhexidine gluconate is more effective on the reduction of surgical site microbial colonization and subsequent infection than is normal saline.

Surgical site infections (SSIs) following elective surgical procedures occur most commonly as a result of colonization by the patient's native skin flora . The most common pathogens causing SSIs are Staphylococcus aureus and coagulase-negative Staphylococci , components of normal skin flora . Therefore, preoperative disinfection of the surgical site with an antiseptic skin preparation is standard practice before any surgical intervention to decrease skin microbial counts before incision . It is considered an important step in limiting surgical wound contamination and preventing infection.

A variety of skin-preparation agents and methods are available for preventing surgical site infections and the techniques for preoperative cleansing of the skin vary among hospitals and surgeons. There is a pressing need to elucidate the effect of cutaneous disinfection with chlorhexidine gluconate ( CHG ) in prevention of surgical site infections.

Many studies demonstrated that comparisons with cutaneous disinfection with povidone-iodine, disinfection with CHG before insertion of an intravascular device and for post-infection site care can substantially reduce the incidence of device-related infection .

Hence, this study aimed to test whether an additional chlorhexidine gluconate scrub followed by a routine disinfection would lower the incidence of surgical site culture and subsequent infection after hepatic resection. This data will show the originality and clinical importance of a cutaneous pre-disinfection scrubbing solution for such risk patients with hepatectomy.

The Efficacy of Chlorhexidine Gluconate Pre - Disinfection Scrubbing in Preventing Surgical Site Infections for Hepatectomy Patients

The Efficacy of Pre - Disinfection Skin Scrub With 4% Chlorhexidine Gluconate in Preventing Surgical Site Infections for Patients With Hepatectomy

1. Before surgical preparation while the patient was on the table in the operating room , we obtained the first set of aerobic culture from the predefined incision site as the baseline culture.
2. After skin scrubbing and disinfection , we obtained the second set of aerobic culture from the predefined incision site as the preoperative culture.
3. After closure of the wound , we obtained the third set of aerobic culture from the surgical site as the postoperative culture.
4. The result of culture was positive if bacteria were cultured from either stage of the surgical site sampling.
5. We compared the efficacy for eradicating aerobic bacterial pathogens ( reduction of positive culture )from the abdomen between the chlorhexidine gluconate scrubbing group and normal saline scrubbing group .

Surgical site infection was using modified US Centers for Disease Control and Prevention definitions for nosocomial infection and documented by visiting patients everyday during the duration of hospitalization after surgery . After discharge , patients were checked weekly in the outpatient clinic to assess the surgical sites infection . All surgical site infections were classified as superficial , deep wound , or organ / space infection .

We compared the incidence of post - operative surgical site infection between the chlorhexidine gluconate scrubbing group and normal saline scrubbing group .

Changhua Christian Hospital

Head and Neck Neoplasms

Doxycycline

Tetracycline

Minocycline

Plasma Substitutes

Enzyme Inhibitors

Antimalarials

Antiprotozoal Agents

Antiparasitic Agents

Preoperative: The patient's dentition, or mandibular alveolus in the absence of dentition, will be brushed for two minutes with 0.12% chlorhexidine gluconate.

Intraoperative: The wound will be irrigated for 60 seconds with 0.05% chlorhexidine after it is irrigated with povidone-iodine.

Postoperative: Patients will swish and spit/suction 15mL 0.12% Chlorhexidine Gluconate (CHG) oral rinses for 30 seconds every six hours for two days (8 total administrations)

Chlorhexidine Gluconate

Preoperative: The oral cavity and oropharyngeal mucosa as well as the nasal vestibules will be coated with 5% povidone-iodine which will stand for at least three minutes prior to incision.

Intraoperative: The wound will be irrigated for 60 seconds with 10% povidone-iodine.

Povidone-iodine

Postoperative: \~10g 3% tetracycline ointment will be placed into the oral cavity to coat the dorsal tongue and any oral suture lines every six hours for two days (8 total doses).

Tetracycline Ointment

Joseph Zenga, MD

This is a single-arm prospective trial of an intra- and postoperative topical antiseptic bundle. The study will recruit patients undergoing an open surgical resection of the upper aerodigestive tract requiring a planed vascularized reconstruction, which may be either pedicled and/or free flap. The objectives are to evaluate antimicrobial effects of a perioperative topical antiseptic bundle and to identify the source of surgical site infection as well as the rate of 30-day adverse events in head and neck cancer.

The study design is a single-arm prospective trial. It will investigate the microbial effects of topical antisepsis on upper aerodigestive tract and reconstructive surgery in head and neck cancer patients. The primary hypothesis is that topical antisepsis will significantly decrease oral bacterial load and the presence of pathogenic organisms. Secondary outcomes will include identification of the source of the infectious bacterial organisms, surgical and non-surgical site infections, serious topical antisepsis-related complications, serious adverse events, and hospital revisits. The study populations will include head and neck cancer patients age 18 or greater undergoing head and neck reconstructive surgery in which there is a communication between the upper aerodigestive tract and the cervical skin which requires a planned vascularized reconstruction, either a regional pedicled flap or a free tissue transfer. The accrual goal will be 25 patients. Data collection will occur in both the inpatient and outpatient settings. Patients will be enrolled during their preoperative clinic visit. Each patient will be followed for study outcomes until 30 days postoperatively.

Swabs will be taken of the mouth, nose, surgical site and environment. Recombinant 16s DNA (16 s) sequencing will be used to identify bacteria present at those sites.

Topical Antisepsis in Head and Neck Cancer Surgery

A Topical Antiseptic Bundle for Decreasing Surgical Site Infection in Head and Neck Cancer Patients: Perioperative Effects on the Oral Microbiome

Bacteria will be measured as colony forming unit/mL.

This will be measured by the number of operational taxonomic units.

Surgical site infection diagnosis must be performed by the attending physician and occur within 30 days post-operatively. Diagnosis will include either: 1) purulent drainage from incision, 2) incision spontaneously dehisced or opened by the surgeon because of infection, 3) abscess or other evidence of infection involving a deep incision; or 4) surgical site infection diagnosis by the surgeon.

Defined as any unanticipated hospital readmission within 30 days of the index surgery.

An infection of the tracheobronchial tree, urinary tract, or blood, as determined by the isolation of pathogenic microorganisms from these sites in the setting of clinical signs and symptoms of infection in accordance with the International Nosocomial Infection Control Consortium (INICC) criteria. Pneumonia, clinical sepsis, and symptomatic urinary tract infection without an identified pathogenic microorganism may be diagnosed according to the INICC guidelines.

Serious adverse event is deemed related to or probably related to the topical antiseptic agent. When topical antiseptic-related complications are suspected by the attending physician, the infectious disease service will be consulted, and a serious topical antiseptic-related complication will be diagnosed based on their recommendations.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Trial to Assess the Effects of an Antimicrobial Mouthwash on the Esophageal Microbiome	NCT02513784	Esophageal Aden... Barrett's Esoph... Reflux Esophagi...	Chlorhexidine g...	18 Years -	Columbia University
The Efficacy of Chlorhexidine Gluconate Pre - Disinfection Scrubbing in Preventing Surgical Site Infections for Hepatectomy Patients	NCT01782573	Liver Tumors	Chlorhexidine g... 0.9% Sodium Chl...	18 Years - 92 Years	Changhua Christian Hospital
Topical Antisepsis in Head and Neck Cancer Surgery	NCT04721626	Head and Neck C...	Chlorhexidine G... Povidone-iodine Tetracycline Oi...	18 Years -	Medical College of Wisconsin
Trial to Assess the Effects of an Antimicrobial Mouthwash on the Esophageal Microbiome	NCT02513784	Esophageal Aden... Barrett's Esoph... Reflux Esophagi...	Chlorhexidine g...	18 Years -	Columbia University

Spots Global Cancer Trial Database for chlorhexidine gluconate