Clinical trial · Interventional
A Randomized Controlled Trial To Evaluate The Use Of Botox In Breast Reconstruction With Tissue Expanders
NCT01765309CI-TRIAL-00008895completedN/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)
Investigation of whether injection of the pectoralis muscle with 100 units botulinum toxin during breast reconstruction with tissue expanders results in decreased pain using a blinded, randomized, controlled trial.
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 |
|---|---|---|---|
| Bilateral mastectomy with reconstruction | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Bilateral mastectomy with reconstruction
- description
- The trial was a comparison between each breast in a single patient undergoing bilateral mastectomy with reconstruction
- interventionNames
- Procedure: Bilateral mastectomy with reconstruction
Primary outcomes (1)
- measure
- Difference between preoperative and postoperative pain scale
- timeFrame
- 12 weeks
- description
- Patients reported pain in each breast on a visual analog scale of 1-10 at each clinic visit
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Bilateral mastectomy with immediate tissue expander reconstruction Exclusion Criteria: * Unwilling to receive study injections
References
Publications (0)
Data not yet available
No reference posted for this study.