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

Scar Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02886988
• Other study ID #: KY20162057-2
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: August 29, 2016
• Last updated: January 23, 2018
• Start date: October 2016
• Est. completion date: January 22, 2018

Study information

• Verified date: August 2016
• Source: Xijing Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: January 22, 2018
• Est. primary completion date: December 28, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Scar

Intervention

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

Locations

Country	Name	City	State
China	Xijing Hospital	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Xijing Hospital

Country where clinical trial is conducted

China, 

References & Publications (8)

Chen M, Yan T, Ma K, Lai L, Liu C, Liang L, Fu X. Botulinum Toxin Type A Inhibits a-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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Scar width	At 6-month follow-up, scar width will be measured by ultrasonography.	6 months after Botulinum toxin type A injection
Secondary	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