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Trial record 26 of 720 for:    Botulinum Toxins, Type A

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

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ClinicalTrials.gov Identifier: NCT02886988
Recruitment Status : Completed
First Posted : September 1, 2016
Last Update Posted : January 25, 2018
Sponsor:
Information provided by (Responsible Party):
Xijing Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Scar Drug: Botulinum toxin type A Drug: normal saline Phase 2 Phase 3

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official 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
Study Start Date : October 2016
Actual Primary Completion Date : December 28, 2017
Actual Study Completion Date : January 22, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox Scars

Arm Intervention/treatment
Experimental: Botulinum toxin type A
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
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

Placebo Comparator: Normal Saline
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
0.1mlof normal saline will be injected with a 30G needle.
Other Name: NaCl 0.9%




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02886988


Locations
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China, Shaanxi
Xijing Hospital
Xi'an, Shaanxi, China, 710032
Sponsors and Collaborators
Xijing Hospital
Investigators
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Principal Investigator: Song-Tao Xie Xijing Hospital

Publications:

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Responsible Party: Xijing Hospital
ClinicalTrials.gov Identifier: NCT02886988     History of Changes
Other Study ID Numbers: KY20162057-2
First Posted: September 1, 2016    Key Record Dates
Last Update Posted: January 25, 2018
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Xijing Hospital:
Botulinum toxin type A, scar

Additional relevant MeSH terms:
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Botulinum Toxins
Botulinum Toxins, Type A
abobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents