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

Primary Purpose

Scar

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Botulinum toxin type A
normal saline
Sponsored by
Xijing Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Scar focused on measuring Botulinum toxin type A, scar

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Xijing Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Botulinum toxin type A

Normal Saline

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
August 29, 2016
Last Updated
January 23, 2018
Sponsor
Xijing Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02886988
Brief Title
Early Postoperative Prevention and Treatment of Median Sternotomy Scars With Botulinum Toxin Type A Injection
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 Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
October 2016 (undefined)
Primary Completion Date
December 28, 2017 (Actual)
Study Completion Date
January 22, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xijing Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scar
Keywords
Botulinum toxin type A, scar

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Botulinum toxin type A
Arm Type
Experimental
Arm Description
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.
Arm Title
Normal Saline
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Botulinum toxin type A
Other Intervention Name(s)
Botox, Botulinum Toxin
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
normal saline
Other Intervention Name(s)
NaCl 0.9%
Intervention Description
0.1mlof normal saline will be injected with a 30G needle.
Primary Outcome Measure Information:
Title
Vancouver scar scale
Description
Vancouver scar scale measures pigmentation, vascularity, pliability and scar height 6 months after received BTA injection.
Time Frame
6 months after Botulinum toxin type A injection
Secondary Outcome Measure Information:
Title
Scar width
Description
At 6-month follow-up, scar width will be measured by ultrasonography.
Time Frame
6 months after Botulinum toxin type A injection
Title
Patient satisfaction
Description
At 6-month follow-up, patients were asked to evaluate their overall satisfaction, using a four-point grading scale for each half the scar.
Time Frame
6 months after Botulinum toxin type A injection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Song-Tao Xie
Organizational Affiliation
Xijing Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Xijing Hospital
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710032
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25946625
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. No abstract available.
Results Reference
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PubMed Identifier
24898579
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.
Results Reference
background
PubMed Identifier
26985661
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.
Results Reference
background
PubMed Identifier
27088929
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.
Results Reference
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PubMed Identifier
25810045
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.
Results Reference
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PubMed Identifier
26665143
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. doi: 10.4172/plastic-surgery.1000934.
Results Reference
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PubMed Identifier
26218391
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.
Results Reference
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PubMed Identifier
25144422
Citation
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.
Results Reference
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Early Postoperative Prevention and Treatment of Median Sternotomy Scars With Botulinum Toxin Type A Injection

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