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Botulinum Toxin Injection After Sternotomies to Improve Scar Aspect and Impact

NCT07013240 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-06-10

No results posted yet for this study

Summary

Sternotomy scars, which are localized in a high-tension area are often dystrophic, hypertrophic or keloidal, and can be difficult to accept to patients who already endured a heavy intervention with high psychologic impact. The investigators wish to evaluate immediate post-surgical injection of botulinum toxin to improve scar aspect and impact. A randomized, placebo-controlled, split-scar clinical trial will determine the improvement of scar aspects assessed by standardized scores (SBSES, POSAS), patient satisfaction and tolerance.

Conditions

  • Sternotomy Closure,Open Heart Surgery

Interventions

DRUG

Botulinum toxin injection

Intervention will be made immediately after surgery, still under general anesthesia, by the cardiac surgeon, after suture. Each patient will receive (either in the lower part or the upper part of the scar according to randomization) 50 international units (IU) of type A botulinum toxin (Botox®, Allergan aesthetics) diluted in 1 mL of saline to enable injection of 5 IU at each point, every centimeter, at 1 cm of each scar side. An equivalent volume of saline will be injected under the same modalities in the other part of the scar.

Sponsors & Collaborators

  • University Hospital, Bordeaux

    lead OTHER

Principal Investigators

  • Robin ZAGALA, MD · University Hospital, Bordeaux

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-05
Primary Completion
2027-02-28
Completion
2027-02-28

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07013240 on ClinicalTrials.gov