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Breast CancerNCT03229824

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

A study testing Antiseptic occlusive dressing group in people with Breast Cancer, run by National Institute of Cancerología at 1 site in Mexico.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Cancer
What is being tested?
Antiseptic occlusive dressing group
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
116 participants
Where
1 siteMexico
Study dates
3 Oct 2016to 30 May 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Females minimum age 18 able to give informed consent
  • Breast cancer confirmed by histopathology
  • Patients undergoing unilateral or bilateral mastectomy with or without immediate expander reconstruction.

Who cannot join

  • Males
  • Patients who deny informed consent
  • Prior radiation therapy to the sick breast.
  • Pregnant or breastfeeding women
  • Patients undergoing immediate breast reconstruction with Deep Inferior
  • Epigastric Perforator (DIEP) o Transverse Rectus Abdominal Muscle techniques (TRAM) .
Show all 12Show fewer
  • Emergency procedures
  • Documented allergy to chlorhexidine gluconate
  • Antibiotic use in the fourteen days prior to surgical date
  • Patients with a history or suspicion of breast cancer surgery outside the INCan in the previous three months.
  • Patients who do not speak spanish, diagnosed with a psychiatric disorder and in whom a minimum follow-up of 14 days couldn't be feasible because of operative difficulties (eg.
  • place of residence or reference to other health institutions).

Trial locations and contacts

1 site in 1 country.

Mexico1 site

  • Instituto Nacional de Cancerología

    Mexico City, Mexico City, 14080

Other trials in Mexico

About this study

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

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.

Read the detailed description

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.

Conditions
Breast Cancer
Being tested
Antiseptic occlusive dressing group
Keywords
Drain antisepsis, Bacterial colonization, Surgical site infection
Medical subject headings
Breast Neoplasms, Surgical Wound Infection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Antiseptic occlusive dressing groupDevice

    Also called Tegaderm CHG Dressing

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

Study groups in NCT03229824
Study groupRoleWhat they receive
Antiseptic occlusive dressing groupExperimentalA chlorhexidine gluconate occlusive adhesive dressing (Tegaderm CHG) will be applied to the intervention drain sites and changed every seven days.
Receives: Device: Antiseptic occlusive dressing group
Standard careNo interventionStandard 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of subjects with drain bulb fluid bacterial colonization at the first and second week postoperative.

    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.

    Measured: Approximately 1 or 2 weeks after surgery

  2. Number of subjects with drain tip bacterial colonization at removal.

    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.

    Measured: Approximately at the second and/or third week after surgery

Secondary outcomes (1)

  1. Number of Subjects With Surgical Site Infection Within 30 Days

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

    Measured: Approximately 30 days after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jul 2017
  2. Study start3 Oct 2016
  3. Primary completion30 Apr 2018
  4. Study completion30 May 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
116 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03229824
Sponsor's protocol ID
CEI/1090/16
Status last verified
Nov 2018
First submitted
21 Apr 2017
Last updated
13 Nov 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Results at the end of study

Publications

  • Torre LA, Bray F, Siegel RL, Ferlay J, Lortet-Tieulent J, Jemal A. Global cancer statistics, 2012. CA Cancer J Clin. 2015 Mar;65(2):87-108. doi: 10.3322/caac.21262. Epub 2015 Feb 4.

    PubMed 25651787

  • Instituto Nacional de Geografía y estadística. "Estadísticas a propósito del día mundial de la lucha contra el cáncer de mama (19 de octubre)". Recuperado el 15 de febrero del 2016, de www.inegi.org.mx/aproposito/mama0

  • Arce et al. Oncoguía: Cáncer de Mama. Cancerología 6, 2001; p77-86.

  • Vilar-Compte D, Mohar A, Sandoval S, de la Rosa M, Gordillo P, Volkow P. Surgical site infections at the National Cancer Institute in Mexico: a case-control study. Am J Infect Control. 2000 Feb;28(1):14-20. doi: 10.1016/s0196-6553(00)90006-3.

    PubMed 10679132

  • Olsen MA, Chu-Ongsakul S, Brandt KE, Dietz JR, Mayfield J, Fraser VJ. Hospital-associated costs due to surgical site infection after breast surgery. Arch Surg. 2008 Jan;143(1):53-60; discussion 61. doi: 10.1001/archsurg.2007.11.

    PubMed 18209153

  • Olsen MA, Lefta M, Dietz JR, Brandt KE, Aft R, Matthews R, Mayfield J, Fraser VJ. Risk factors for surgical site infection after major breast operation. J Am Coll Surg. 2008 Sep;207(3):326-35. doi: 10.1016/j.jamcollsurg.2008.04.021. Epub 2008 Jun 26.

    PubMed 18722936

  • Edwards JR, Peterson KD, Mu Y, Banerjee S, Allen-Bridson K, Morrell G, Dudeck MA, Pollock DA, Horan TC. National Healthcare Safety Network (NHSN) report: data summary for 2006 through 2008, issued December 2009. Am J Infect Control. 2009 Dec;37(10):783-805. doi: 10.1016/j.ajic.2009.10.001. No abstract available.

    PubMed 20004811

  • Felippe WA, Werneck GL, Santoro-Lopes G. Surgical site infection among women discharged with a drain in situ after breast cancer surgery. World J Surg. 2007 Dec;31(12):2293-9; discussion 2300-1. doi: 10.1007/s00268-007-9248-3.

    PubMed 17917771

  • Ruvalcaba-Limon E, Robles-Vidal C, Poitevin-Chacon A, Chavez-Macgregor M, Gamboa-Vignolle C, Vilar-Compte D. Complications after breast cancer surgery in patients treated with concomitant preoperative chemoradiation: A case-control analysis. Breast Cancer Res Treat. 2006 Jan;95(2):147-52. doi: 10.1007/s10549-005-9058-y. Epub 2005 Dec 1.

    PubMed 16319989

  • Prospero E, Cavicchi A, Bacelli S, Barbadoro P, Tantucci L, D'Errico MM. Surveillance for surgical site infection after hospital discharge: a surgical procedure-specific perspective. Infect Control Hosp Epidemiol. 2006 Dec;27(12):1313-7. doi: 10.1086/509838. Epub 2006 Nov 21.

    PubMed 17152028

  • Vilar-Compte D, Jacquemin B, Robles-Vidal C, Volkow P. Surgical site infections in breast surgery: case-control study. World J Surg. 2004 Mar;28(3):242-6. doi: 10.1007/s00268-003-7193-3. Epub 2004 Feb 17.

    PubMed 14961196

  • Vilar-Compte D, Rosales S, Hernandez-Mello N, Maafs E, Volkow P. Surveillance, control, and prevention of surgical site infections in breast cancer surgery: a 5-year experience. Am J Infect Control. 2009 Oct;37(8):674-9. doi: 10.1016/j.ajic.2009.02.010. Epub 2009 Jun 24.

    PubMed 19556033

  • Vilar-Compte D, Roldan-Marin R, Robles-Vidal C, Volkow P. Surgical site infection (SSI) rates among patients who underwent mastectomy after the introduction of SSI prevention policies. Infect Control Hosp Epidemiol. 2006 Aug;27(8):829-34. doi: 10.1086/506395. Epub 2006 Jul 20.

    PubMed 16874643

  • Landes G, Harris PG, Lemaine V, Perreault I, Sampalis JS, Brutus JP, Lessard L, Dionyssopoulos A, Nikolis A. Prevention of surgical site infection and appropriateness of antibiotic prescribing habits in plastic surgery. J Plast Reconstr Aesthet Surg. 2008 Nov;61(11):1347-56. doi: 10.1016/j.bjps.2008.02.008. Epub 2008 Jun 16.

    PubMed 18558522

  • Throckmorton AD, Hoskin T, Boostrom SY, Boughey JC, Holifield AC, Stobbs MM, Baddour LM, Degnim AC. Complications associated with postoperative antibiotic prophylaxis after breast surgery. Am J Surg. 2009 Oct;198(4):553-6. doi: 10.1016/j.amjsurg.2009.06.003.

    PubMed 19800467

Questions about this trial

What is this clinical trial studying?

A study testing Antiseptic occlusive dressing group in people with Breast Cancer, run by National Institute of Cancerología at 1 site in Mexico.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of subjects with drain bulb fluid bacterial colonization at the first and second week postoperative. (time frame: Approximately 1 or 2 weeks after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03229824, which also lists 31 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2018.

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