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

NCT02886988 | Completed Phase 2 DMC

• 1 other identifier: KY20162057-2
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Scar

Keywords

Botulinum toxin type A, scar

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Scar width

  6 months after Botulinum toxin type A injection

• Patient satisfaction

  6 months after Botulinum toxin type A injection

Study Arms (2)

Botulinum toxin type A

EXPERIMENTAL

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

Normal Saline

PLACEBO COMPARATOR

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

Interventions

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.

Also known as: Botox, Botulinum Toxin

Botulinum toxin type A

normal saline DRUG

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

Also known as: NaCl 0.9%

Normal Saline

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Xijing Hospital: lead

Study Sites (1)

Xijing Hospital

Xi'an, Shaanxi, 710032, China

Location

Related Publications (8)

• 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.

  PMID: 25946625 BACKGROUND

• 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.

  PMID: 24898579 BACKGROUND

• 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.

  PMID: 26985661 BACKGROUND

• 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.

  PMID: 27088929 BACKGROUND

• 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.

  PMID: 25810045 BACKGROUND

• 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.

  PMID: 26665143 BACKGROUND

• 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.

  PMID: 26218391 BACKGROUND

• 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.

  PMID: 25144422 BACKGROUND

MeSH Terms

Conditions

Cicatrix

Interventions

Botulinum Toxins, Type A; Botulinum Toxins; Saline Solution; Sodium Chloride

Condition Hierarchy (Ancestors)

Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Song-Tao Xie

  Xijing Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2016
• First Posted: September 1, 2016
• Study Start: October 1, 2016
• Primary Completion: December 28, 2017
• Study Completion: January 22, 2018
• Last Updated: January 25, 2018

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)