Clinical trial · Interventional
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)
NCT03229824CI-TRIAL-00035734completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Antiseptic occlusive dressing group | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Antiseptic occlusive dressing group
- description
- A chlorhexidine gluconate occlusive adhesive dressing (Tegaderm CHG) will be applied to the intervention drain sites and changed every seven days.
- interventionNames
- Device: Antiseptic occlusive dressing group
- type
- NO_INTERVENTION
- label
- Standard care
- description
- 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.
Primary outcomes (2)
- measure
- Number of subjects with drain bulb fluid bacterial colonization at the first and second week postoperative.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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) . * 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).
References
Publications (31)
- BACKGROUNDTorre 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. PMID 25651787
- BACKGROUNDInstituto 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
- BACKGROUNDArce et al. Oncoguía: Cáncer de Mama. Cancerología 6, 2001; p77-86.
- BACKGROUNDVilar-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. PMID 10679132
- BACKGROUNDOlsen 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. PMID 18209153
- BACKGROUNDOlsen 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. PMID 18722936
- BACKGROUNDEdwards 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. PMID 20004811
- BACKGROUNDFelippe 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.