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Completed

NCT Number: NCT02886988

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

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.

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Key information

Conditions

Scar Cicatrix Fibrosis Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Xijing Hospital

Xi'an, Shaanxi, 710032, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Botulinum Toxin Type A

Drug

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.

Other names: Botox, Botulinum Toxin

normal saline

Drug

0.1mlof normal saline will be injected with a 30G needle.

Other names: NaCl 0.9%

Primary outcomes

  1. Vancouver scar scale

    Time frame: 6 months after Botulinum toxin type A injection

    Vancouver scar scale measures pigmentation, vascularity, pliability and scar height 6 months after received BTA injection.

Secondary outcomes

  1. Scar width

    Time frame: 6 months after Botulinum toxin type A injection

    At 6-month follow-up, scar width will be measured by ultrasonography.

  2. Patient satisfaction

    Time frame: 6 months after Botulinum toxin type A injection

    At 6-month follow-up, patients were asked to evaluate their overall satisfaction, using a four-point grading scale for each half the scar.

Sponsors and collaborators

Lead sponsor

Xijing Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Sep 1, 2016
Registry last updated
Jan 25, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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