Infections

All Conditions

Neoplasms

Skin and Connective Tissue Diseases

Symptoms and General Pathology

Wounds and Injuries

Breast Neoplasms

Communicable Diseases

Surgical Wound Infection

Surgical Wound

Wound Infection

Breast Diseases

Skin Diseases

Postoperative Complications

Anti-Infective Agents

Central Nervous System Depressants

All Drugs and Chemicals

Dermatologic Agents

Ethanol

Chlorhexidine

Chlorhexidine gluconate

Anti-Infective Agents, Local

A chlorhexidine gluconate occlusive adhesive dressing (Tegaderm CHG) will be applied to the intervention drain sites and changed every seven days.

Standard drain care will be performed twice a day or three times if bulb is full and needs to be emptied. Standard drain care consists of stripping the tubing, emptying the drainage bulb, recording the volume of fluid, and cleaning the drain site and the tubing with a cotton swab dipped in rubbing alcohol.

Antiseptic occlusive dressing group

Surgical site infection (SSI) after breast and axillary surgery occurs more often than for other clean surgical procedures. Infection in the setting of sick woman could delay the adjuvant therapy and result increase morbidity and mortality. Also this increased costs associated with health care.Surgical drains have been noted as a potential source for surgical site infections. The primary aim of the study is to determine if chlorhexidine occlusive dressings applied to the intervention drain sites effectively decreases rates of bacterial colonization in drain fluid and drain tips compared to standard care.

Following approval by the National Cancer Institute Review Board, eligible subjects will be recruited prospectively from the Breast Cancer Department at National Cancer Institute, México from November 2016 to November 2017. Individuals with confirmed cancer undergoing total mastectomy (TM), modified radical mastectomy (MRM) and/or axillary lymph node dissection (ALND) in which surgical drains are going to be used will be identified through the surgical scheduling sheet. If the subjects are eligible according to the inclusion criteria, the will be interviewed by one of the main researchers. In the initial interview the informed consent will be read and signed. Also the study coordinator will collect the data of interest from the medical records and will register it in a data collection sheet specially created for this project.

Following informed consent, participants will be randomize to either the standard drain care regimen or the drain antisepsis regimen by a computerized randomization program, using dynamic allocation and stratifying by surgical procedure (radical surgery or conservative surgery). Subjects who had bilateral cancer underwent to the same regimen for both sides. The operating surgeon will know the assigned treatment arm at the end of the surgery.

The surgery will consist on placing a chlorhexidine gluconate occlusive adhesive dressing to the drains side at the end of the surgery. The dressing will be changed each 7 (+-1) days until the drain is removed.

All the participants and the principal take-carers, despite of the group of participation, will be personal instructed by a member of the research team in the first hours of the postoperative, before the departure. In addition, they will be given paper based instructions for the general care of the drain and the surgery wound.

For the experimental group, the dressing will be changed each 7(+-1) days; The site of the insertion must be cleaned with 70% concentration isopropyl alcohol towels. The evaluation and quantification of the drained fluid will be done every 12 hours as it is done usually in these patients.

The patients will be followed for 30 days from the surgery until the resolution of the infectious complication, if it occurs. The patients will go at the end of the first postoperative week (POP 7+-1). In each visit, the coordinator of the study will register the information of the patient in the register sheet. In each visit the patient will be evaluated, the characteristics of the surgical wound and the characteristics of drain fluid will be consigned in the protocol register sheet. The investigator will verify that the participants have correctly done the clean-up the drain.

All patients will undergo semiquantitative cultures of the drain bulb at the first and second week postoperative. Also the investigators will take the distal part of the internal segment of each removed drainage tube for semiquantitative culture. All participants will be evaluated for clinical signs of infection and for any adverse reactions to the drain antisepsis at the follow-up visits. In case of a surgical site infection, the patient will receive the right treatment and will remain in surveillance until the resolution.

Use of Clorhexidine Dressings to Reduce Surgical Site Infections in Breast Cancer Surgery. A Controlled Clinical Trial

Randomized Controlled Trial to Reduce Surgical Site Infections in Breast Cancer Surgery With Clorhexidine Gluconate Securement Dressing (Tegaderm CHG)

Bacterial growth was defined as plate growth \>10\*5 colony forming unit (CFU). Drains were removed at variable times across patients, per clinical indication. When clinically indicated, some patients did have their drains removed at the one week visit, in which case they only had one bulb fluid culture.

Bacterial growth was defined as plate growth \>15 CFU by semiquantitative technique or \>10\*5 CFU by sonication and fluid culture. Drains were removed at variable times across patients, per clinical indication.

Surgical site infection was diagnosed according the definitions given by the Centers for Disease Control and Prevention (CDC).

Instituto Nacional de Rehabilitacion

National Institute of Cancerología

Ethics Commissioner

Mouth and Tooth Diseases

Ear, Nose, and Throat Diseases

Digestive System Diseases

Behaviors and Mental Disorders

Rare Diseases

Carcinoma

Stomatitis

Nasopharyngeal Carcinoma

Mucositis

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Nasopharyngeal Neoplasms

Pharyngeal Neoplasms

Otorhinolaryngologic Neoplasms

Head and Neck Neoplasms

Nasopharyngeal Diseases

Pharyngeal Diseases

Stomatognathic Diseases

Otorhinolaryngologic Diseases

Gastroenteritis

Gastrointestinal Diseases

Mouth Diseases

Quality of Life

Mupirocin

Anti-Bacterial Agents

Enzyme Inhibitors

The purpose of this study is to determine whether bacterial decolonization of the nares prior to treatment with radiotherapy (RT) for patients with nasopharyngeal carcinoma, can prevent radiation-induced oral mucositis(RIOM) and improve quality of life.

Patients in the control arm will be treated according to standard of care.

Patients in the intervention arm will receive a decolonization regimen, consisting of intranasal mupirocin ointment to be applied twice daily to the nares

Mupirocin Ointment

Tianzhu Lu, PhD

Tianzhu Lu

Jingao Li

Zhaohui Liao

Xiaochang Gong

The purpose of this study is to determine whether bacterial decolonization of the nares prior to treatment with radiotherapy (RT) for patients with nasopharyngeal carcinoma, can prevent high-grade radiation-induced oral mucositis (RIOM) and improve quality of life.

This study is being conducted because a randomized clinical trials form Yana Kost et al. have found bacterial decolonization in the nose prior to initiation of RT was effective for prevention of acute radiation dermatitis.

Patients in the treatment arm will receive pretreatment with mupirocin ointment to the nares while patients in the control arm will receive standard of care treatment. Bacterial cultures will be taken from the nares and mouth, and participants will also complete a quality of life questionnaire before and after RT.

Bacterial Decolonization to Prevent Radiation-induced Oral Mucositis

Bacterial Decolonization to Prevent Radiation-induced Oral Mucositis: A Randomized Controlled Trial and Quality of Life Assessment

Grade 3 or higher radiation-induced oral mucositis according to RTOG

Grade 3 or higher radiation-induced dermatitis according to RTOG

Jiangxi Provincial Cancer Hospital

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Use of Clorhexidine Dressings to Reduce Surgical Site Infections in Breast Cancer Surgery. A Controlled Clinical Trial	NCT03229824	Breast Cancer	Antiseptic occl...	18 Years -	National Institute of Cancerología
Bacterial Decolonization to Prevent Radiation-induced Oral Mucositis	NCT05893810	Nasopharyngeal ... Radiation-induc... Bacterial Colon... Quality of Life	Mupirocin Ointm...	18 Years - 70 Years	Jiangxi Provincial Cancer Hospital

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