Early Postoperative Prevention and Treatment of Median Sternotomy Scars With Botulinum Toxin Type A Injection

Study Overview
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Brief Summary
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Linear hypertrophic scar is a common surgical problem that can be difficult to manage, especially for the median sternotomy scar. Despite high demand for the early intervention to prevent and treat surgical scars, there is yet no universal consensus on satisfactory treatment. Botulinum toxin type A is a neurotoxin that has been widely and safely used in medicine for more than 30 years. It induces chemodenervation through acting on the presynaptic neuron to prevent release of acetylcholine, which leads to functional denervation of striated muscle for about 6 months after injection. The aim of this randomized controlled trial is to evaluate the efficacy of Botulinum toxin type A as a prophylactic treatment in the early postoperative of median sternotomy for the purpose of preventing excess scar formation.

Detailed Description
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The goal of this study is to conduct a randomized controlled trial about using Botulinum toxin type A ( BTA) to prevent hypertrophic scar in median sternotomy wound. The entire median sternotomy wound was divided into the upper half and the lower half. Both halves of the wound were randomized to receive treatment with either BTA or 0.9% normal saline. The patient and the surgeon will be blinded to the treatment arm. The primary end point was the evaluation of upper and lower half scar using the Vancouver Scar Scale (VSS). At 6 months follow-up, two blinded dermatologists examined the patients and took photographs of the scar in the outpatient clinic of XiJing Hospital. Scars were assessed using the VSS and assigned the mean score of the two observers. At 6-month follow-up, ultrasonography to measure the scar width will be performed. At the same time, patients were asked to evaluate their overall satisfaction, using a four-point grading scale for each half the scar(1= very satisfied, 2= satisfied,3= slightly satisfied, 4= unsatisfied ).Paired t-test was used to compare the VSS scores, scar width and the overall satisfaction between the BTA-treated group and normal saline group.

Official Title
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A Randomized, Placebo-Controlled, Double-Blind, Prospective Clinical Trial of Botulinum Toxin Type A in Prevention of Hypertrophic Scar Development in Median Sternotomy Wound

Conditions
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Scar

Intervention / Treatment
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* Drug: Botulinum toxin type A
* Drug: normal saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients included are older than 18 years with a median sternotomy less than 14 days. Patients are willing and able to participate in the study as an outpatient, making several visits to the study center during the treatment and follow-up periods. Patients can comply with all study requirements including concomitant medication and other treatment restrictions. Patients have good wound healing condition, without infection sign. Exclusion Criteria: The exclusion criteria applied is current pregnancy or breast feeding, allergy to botulinum toxin type A, previous injection of botulinum toxin within 6 months prior to enrollment, Myasthenia gravis or other neuromuscular disorder,and refusal to participate in this trial.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Botulinum toxin type A<br>The entire median sternotomy wound was divided into the upper half and the lower half. Both halves of the wound were randomized to receive treatment with either BTA or 0.9% normal saline.100U Botulinum toxin type A(BTA) will be reconstituted with 2mL of normal saline for a concentration of 50U/mL. 0.1ml(5 units) of BTA will be injected along the wound edges. The injections will be administered within 14 days of median sternotomy with a 30G needle. | Drug: Botulinum toxin type A<br>* 50 units of botulinum toxin diluted in 1 ml of normal saline will be administered. 0.1mlof BTA will be injected with a 30G needle.<br>* Other names: Botulinum Toxin;|
| Placebo Comparator: Normal Saline<br>The entire median sternotomy wound was divided into the upper half and the lower half. Both halves of the wound were randomized to receive treatment with either BTA or 0.9% normal saline.0.1ml normal saline will be injected along the wound edges. | Drug: normal saline<br>* 0.1mlof normal saline will be injected with a 30G needle.<br>* Other names: NaCl 0.9%;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vancouver scar scale | Vancouver scar scale measures pigmentation, vascularity, pliability and scar height 6 months after received BTA injection. | 6 months after Botulinum toxin type A injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scar width | At 6-month follow-up, scar width will be measured by ultrasonography. | 6 months after Botulinum toxin type A injection | 
| Patient satisfaction | At 6-month follow-up, patients were asked to evaluate their overall satisfaction, using a four-point grading scale for each half the scar. | 6 months after Botulinum toxin type A injection | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Botulinum toxin type A, scar