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ScarPhase 2/3NCT02886988

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

A Phase 2/3 study testing Botulinum toxin type A and normal saline in people with Scar, run by Xijing Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Scar
What is being tested?
Botulinum toxin type A and normal saline
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
17 participants
Where
1 siteChina
Study dates
Oct 2016to 22 Jan 2018
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Xijing Hospital

    Xi'an, Shaanxi, 710032

Other trials in China

About this study

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

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.

Read the 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.

Conditions
Scar
Being tested
Botulinum toxin type A, normal saline
Keywords
Botulinum toxin type A, scar
Medical subject headings
Cicatrix

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Botulinum toxin type ADrug

    Also called Botox, Botulinum Toxin

    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.

  • normal salineDrug

    Also called NaCl 0.9%

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

Study groups in NCT02886988
Study groupRoleWhat they receive
Botulinum toxin type AExperimentalThe 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.
Receives: Drug: Botulinum toxin type A
Normal SalinePlacebo comparatorThe 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.
Receives: Drug: normal saline

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Vancouver scar scale

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

    Measured: 6 months after Botulinum toxin type A injection

Secondary outcomes (2)

  1. Scar width

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

    Measured: 6 months after Botulinum toxin type A injection

  2. 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.

    Measured: 6 months after Botulinum toxin type A injection

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Sep 2016 (estimated)
  2. Study startOct 2016
  3. Primary completion28 Dec 2017
  4. Study completion22 Jan 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
17 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02886988
Sponsor's protocol ID
KY20162057-2
Status last verified
Aug 2016
First submitted
29 Aug 2016
Last updated
25 Jan 2018
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Ozog DM, Moy RL. Discussing Fractional Carbon Dioxide Laser and Other Physical Treatments for Scar Prevention With Patients. JAMA Dermatol. 2015 Aug;151(8):815-6. doi: 10.1001/jamadermatol.2015.0594. No abstract available.

    PubMed 25946625

  • Kim YS, Lee HJ, Cho SH, Lee JD, Kim HS. Early postoperative treatment of thyroidectomy scars using botulinum toxin: a split-scar, double-blind randomized controlled trial. Wound Repair Regen. 2014 Sep-Oct;22(5):605-12. doi: 10.1111/wrr.12204. Epub 2014 Aug 26.

    PubMed 24898579

  • Zhang DZ, Liu XY, Xiao WL, Xu YX. Botulinum Toxin Type A and the Prevention of Hypertrophic Scars on the Maxillofacial Area and Neck: A Meta-Analysis of Randomized Controlled Trials. PLoS One. 2016 Mar 17;11(3):e0151627. doi: 10.1371/journal.pone.0151627. eCollection 2016.

    PubMed 26985661

  • Elhefnawy AM. Assessment of intralesional injection of botulinum toxin type A injection for hypertrophic scars. Indian J Dermatol Venereol Leprol. 2016 May-Jun;82(3):279-83. doi: 10.4103/0378-6323.173586.

    PubMed 27088929

  • Shaarawy E, Hegazy RA, Abdel Hay RM. Intralesional botulinum toxin type A equally effective and better tolerated than intralesional steroid in the treatment of keloids: a randomized controlled trial. J Cosmet Dermatol. 2015 Jun;14(2):161-6. doi: 10.1111/jocd.12134. Epub 2015 Mar 24.

    PubMed 25810045

  • Prodromidou A, Frountzas M, Vlachos DE, Vlachos GD, Bakoyiannis I, Perrea D, Pergialiotis V. Botulinum toxin for the prevention and healing of wound scars: A systematic review of the literature. Plast Surg (Oakv). 2015 Winter;23(4):260-4. doi: 10.4172/plastic-surgery.1000934.

    PubMed 26665143

  • Jeong HS, Lee BH, Sung HM, Park SY, Ahn DK, Jung MS, Suh IS. Effect of Botulinum Toxin Type A on Differentiation of Fibroblasts Derived from Scar Tissue. Plast Reconstr Surg. 2015 Aug;136(2):171e-178e. doi: 10.1097/PRS.0000000000001438.

    PubMed 26218391

  • Chen M, Yan T, Ma K, Lai L, Liu C, Liang L, Fu X. Botulinum Toxin Type A Inhibits alpha-Smooth Muscle Actin and Myosin II Expression in Fibroblasts Derived From Scar Contracture. Ann Plast Surg. 2016 Sep;77(3):e46-9. doi: 10.1097/SAP.0000000000000268.

    PubMed 25144422

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Botulinum toxin type A and normal saline in people with Scar, run by Xijing Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Vancouver scar scale (time frame: 6 months after Botulinum toxin type A injection). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02886988, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2018.

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