Clinical trial · Interventional
Trial of Drain Antisepsis After Tissue Expander Breast Reconstruction
NCT01286168CI-TRIAL-00016390completedPhase 2Results postedClinicalTrials.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 a tissue expander can be devastating and can lead to early implant loss and failed reconstruction. Surgical drains have been noted as a potential source for surgical site infections. Hypothesis: Bacteria present in surgical drains after tissue expander reconstruction may be decreased by simple and inexpensive local antiseptic interventions.
Conditions
Conditions (2)
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 |
| Nonmalignant Breast Conditions | Breast Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chlorhexidine gluconate disk | Device | — | UNRESOLVED |
| Control | Procedure | — | UNRESOLVED |
| Occlusive Adhesive Dressing | Device | — | UNRESOLVED |
| Sodium hypochlorite (Dakin's Solution) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Antisepsis Side
- description
- A chlorhexidine gluconate disk (BioPatch) covered by an occlusive adhesive dressing (Tegaderm) will be applied to the intervention drain sites and changed every three days. The drainage bulb will be irrigated with 10ml of 0.125% sodium hypochlorite (Dakin's solution) twice a day.
- interventionNames
- Device: Sodium hypochlorite (Dakin's Solution)
- Device: Chlorhexidine gluconate disk
- Device: Occlusive Adhesive Dressing
- type
- OTHER
- label
- Control Side
- 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 with a cotton swab dipped in rubbing alcohol. The drain exit will be covered with a dry sterile gauze dressing and changed after each episode of drain care.
- interventionNames
- Procedure: Control
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: * Females or males age 18-90 able to give informed consent * Undergoing bilateral mastectomy with immediate expander reconstruction or immediate implant reconstruction * May have either malignant or benign breast condition Exclusion Criteria: * Antibiotic use in the fourteen days prior to surgical date * Undergoing unilateral tissue expander reconstruction * Documented allergy to chlorhexidine gluconate * Prior radiation therapy to the breast or chest wall (ie for breast conservation or mantle radiation for Hodgkin's disease) * Documented allergy to all three of the following antibiotics: cephalosporin, trimethoprim/sulfamethoxazole, and levofloxacin * Pregnant women * Vulnerable subjects - prisoners, institutionalized individuals * Non-English speaking patients without adequate interpreter assistance
References
Publications (1)
- DERIVEDDegnim AC, Scow JS, Hoskin TL, Miller JP, Loprinzi M, Boughey JC, Jakub JW, Throckmorton A, Patel R, Baddour LM. Randomized controlled trial to reduce bacterial colonization of surgical drains after breast and axillary operations. Ann Surg. 2013 Aug;258(2):240-7. doi: 10.1097/SLA.0b013e31828c0b85. PMID 23518704