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NCT01427400UNKNOWNanonymous

The Use of Botulinum Toxin-A in Two-stage Tissue Expander/Implant Breast Reconstruction: A Prospective, Randomized, Double-Blind Placebo Controlled Trial

Sponsor

Source record

University of British Columbia

Phase

Source record

PHASE4

Modality

AI-normalized

small molecule

Target

AI-normalized

Botulinum Toxin-A, Saline

Indication / condition

AI-normalized

Breast Neoplasms

Intervention

Source record

Botulinum Toxin-A, Saline

Source & freshness

Source record

NCT ID

NCT01427400

Original source

ClinicalTrials.gov

Source last updated

Jul 29, 2016

Ingested at

Jun 11, 2026

Internal sync

Jun 11, 2026

Model version

trialsignal-ai-v1

Normalized confidence

96%

Validation status

validated

Open original registry record
View original source fields

NCT ID

NCT01427400

Title

The Use of Botulinum Toxin-A in Two-stage Tissue Expander/Implant Breast Reconstruction: A Prospective, Randomized, Double-Blind Placebo Controlled Trial

Sponsor

University of British Columbia

Status

UNKNOWN

Phase

PHASE4

Condition raw

Breast Neoplasms, Neoplasms by Site, Neoplasms, Breast Diseases, Skin Diseases

Condition normalized

Breast Neoplasms, Neoplasms by Site, Neoplasms, Breast Diseases, Skin Diseases

Modality raw

small molecule

Modality normalized

small molecule

Target raw

Botulinum Toxin-A, Saline

Target normalized

Botulinum Toxin-A, Saline

Interventions

Botulinum Toxin-A, Saline

Public preview

Source record

Breast reconstruction is a common procedure with over 86,000 breast reconstruction procedures performed in the United States in 2009. This is a 1.5-fold increase since 2007. Of these breast reconstructions, 65% use a tissue expander/implant technique. Although satisfactory results can be achieved with a single-stage technique, a two-stage approach is considered more reliable, allowing for precise positioning of the inframammary fold and an opportune time to perform a capsulotomy to increase the breast skin flap by releasing the soft tissue.

The placement of the tissue expander and implant under the chest muscles is thought to minimize the incidence of capsular contracture, expander exposure, and in addition, produce acceptable aesthetic results. However, discomfort is often associated with this submuscular placement of a tissue expander or implant, specifically during the expansion phase. Patients undergoing immediate reconstruction using submuscular implants have been shown to have higher analgesic requirements and to have higher pain scores post-operatively, compared to non-reconstructed patients. An uncomfortable reconstruction can lead to under-filling of the expander, a longer expansion process, abandonment of reconstruction, and a compromised quality of life. The use of Botulinum Toxin A (Botox) injections into the chest muscles at the time of surgery may help ease the discomfort that is often associated with this procedure.

The investigators propose a prospective double-blind randomized placebo-controlled trial of patients undergoing tissue expander/implant reconstruction. The information gathered from this analysis will provide a greater understanding of the effects of Botox in the setting of two-stage tissue expander/implant breast reconstruction, with the goal to improve patient satisfaction and quality of life.

AI-generated analysis supports research triage only. Verify source records, publications, sponsor disclosures and IP databases before making diligence decisions. Model: trialsignal-ai-v1.

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