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Botox in the Healing of Surgical Wounds of the Neck

Primary Purpose

Scar

Status
Unknown status
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Botulinum Toxin Type A
Normal Saline
Sponsored by
Nova Scotia Health Authority
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Scar focused on measuring Scar, Botox

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • all patients referred to the ENT clinic for a thyroidectomy or parathyroidectomy

Exclusion Criteria:

  • patients with missing information, including demographic information
  • patients lost to follow up or have been followed for less than 6 months
  • patients with known allergy to lidocaine
  • patients in whom botox would be contraindicated in:
  • known history of neuromuscular disorders (myasthenia gravis, amyotrophic lateral sclerosis, Eaton-Lambert syndrome)
  • pregnant women
  • known allergy to botox, albumin

Sites / Locations

  • Queen Elizabeth II HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Botulinum Toxin A injection

Saline

Arm Description

A vial of Botulinum Toxin A containing 100U of Botox will be reconstituted with 2mL of normal saline for a concentration of 50U/mL. 5 Units (0.1 mL) of Botulinum Toxin A will be injected at three sites along the incision (midline and 1.5 cm lateral to midline) following a thyroidectomy or parathyroidectomy.

0.1 mL of normal saline in a placebo vial containing 2 mL of normal saline will be injected along the incision (midline and 1.5 cm lateral to midline) following a thyroidectomy or parathyroidectomy.

Outcomes

Primary Outcome Measures

Vancouver Scar Scale
The surgeon will assess the healing of the surgical incision at 6 months and fill out the Vancouver Scar Scale following the operation.

Secondary Outcome Measures

Patient and Observer Scar Assessment Scale
The surgeon and the patient will be asked to fill out the survey at 4 weeks following the operation.
Patient and Observer Scar Assessment Scale
The surgeon and the patient will be asked to fill out the survey at 6 months following the operation.
Vancouver Scar Scale
The surgeon will assess the healing of the surgical incision and fill out the Vancouver Scar Scale at 4 weeks following the operation.

Full Information

First Posted
July 8, 2010
Last Updated
September 15, 2014
Sponsor
Nova Scotia Health Authority
Collaborators
Allergan
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1. Study Identification

Unique Protocol Identification Number
NCT01177358
Brief Title
Botox in the Healing of Surgical Wounds of the Neck
Official Title
Botulinum Toxin A in the Healing of Surgical Wounds of the Neck: a Randomized, Prospective, Placebo-controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2010
Overall Recruitment Status
Unknown status
Study Start Date
September 2011 (undefined)
Primary Completion Date
January 2015 (Anticipated)
Study Completion Date
July 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nova Scotia Health Authority
Collaborators
Allergan

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The investigators hypothesize that Botox A will reduce scarring and improve healing of surgical neck wounds.
Detailed Description
Botulinum Toxin A is a toxin produced by the anaerobic bacterial species Clostridium botulinum. The toxin specifically inhibits release of the neurotransmitter Acetylcholine at synaptic junctions, thus preventing neuromuscular transmission, and inducing paralysis of the muscle. Previous studies have indicated that tensile forces on the skin may affect the healing of a wound. These forces act against the immature collagen laid down during wound healing and may stimulate overgrowth, thereby contributing to the formation of hypertrophic scars or keloids. Using botox to paralyse the underlying muscles may reduce the tensile force on the overlying skin, and thus reduce scar formation and promote healing. Botox has also been shown to affect the cell cycle distribution of fibroblasts derived from hypertrophic scars. The objective of this study is to determine the effects of BTX-A in wound healing and the reduction of scar formation. Patients undergoing a thyroidectomy or parathyroidectomy will be randomized to receive either BTX-A injections along the surgical site or placebo immediately following closure. All incisions will be sutured in a similar fashion. BTX-A or normal saline will then be injected along the platysma muscle. The patient and the surgeon will be blinded to the treatment arm. Photographs will be taken of the surgical site at 4 weeks and 6 months. The patient and two otolaryngologists will independently score the healing of the wound using a standardized scoring method. The scores be compared between the two surgeons to determine correspondence and interobserver reliability. The scores of the two treatment arms will be compared to reveal the effect of BTX-A on wound healing.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scar
Keywords
Scar, Botox

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Botulinum Toxin A injection
Arm Type
Experimental
Arm Description
A vial of Botulinum Toxin A containing 100U of Botox will be reconstituted with 2mL of normal saline for a concentration of 50U/mL. 5 Units (0.1 mL) of Botulinum Toxin A will be injected at three sites along the incision (midline and 1.5 cm lateral to midline) following a thyroidectomy or parathyroidectomy.
Arm Title
Saline
Arm Type
Placebo Comparator
Arm Description
0.1 mL of normal saline in a placebo vial containing 2 mL of normal saline will be injected along the incision (midline and 1.5 cm lateral to midline) following a thyroidectomy or parathyroidectomy.
Intervention Type
Drug
Intervention Name(s)
Botulinum Toxin Type A
Other Intervention Name(s)
Allergan Botox, Drug Identification Number 01981501
Intervention Description
A vial of Botulinum Toxin A containing 100U of Botox will be reconstituted with 2mL of normal saline for a concentration of 50U/mL. 5 units (0.1mL) of Botulinum Toxin a will be injected at midline and 1.5cm lateral to midline, bidirectionally, following a thyroidectomy or parathyroidectomy.
Intervention Type
Drug
Intervention Name(s)
Normal Saline
Intervention Description
0.1mL of normal saline in a placebo vial containing 2mL of normal saline will be injected along three sites (midline and 1.5cm lateral from midline) following a thyroidectomy or parathyroidectomy.
Primary Outcome Measure Information:
Title
Vancouver Scar Scale
Description
The surgeon will assess the healing of the surgical incision at 6 months and fill out the Vancouver Scar Scale following the operation.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Patient and Observer Scar Assessment Scale
Description
The surgeon and the patient will be asked to fill out the survey at 4 weeks following the operation.
Time Frame
4 weeks
Title
Patient and Observer Scar Assessment Scale
Description
The surgeon and the patient will be asked to fill out the survey at 6 months following the operation.
Time Frame
6 months
Title
Vancouver Scar Scale
Description
The surgeon will assess the healing of the surgical incision and fill out the Vancouver Scar Scale at 4 weeks following the operation.
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: all patients referred to the ENT clinic for a thyroidectomy or parathyroidectomy Exclusion Criteria: patients with missing information, including demographic information patients lost to follow up or have been followed for less than 6 months patients with known allergy to lidocaine patients in whom botox would be contraindicated in: known history of neuromuscular disorders (myasthenia gravis, amyotrophic lateral sclerosis, Eaton-Lambert syndrome) pregnant women known allergy to botox, albumin
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elaine W Fung, BSc, MD
Phone
1-902-412-1240
Email
elaine.fung@dal.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Taylor, FRCS
Organizational Affiliation
Capital District Health Authority Nova Scotia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Queen Elizabeth II Hospital
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 1V7
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elaine W Fung, MD, BSc
Phone
1-902-412-1240
Email
elaine.fung@dal.ca
First Name & Middle Initial & Last Name & Degree
Mark Taylor, FRCS

12. IPD Sharing Statement

Citations:
PubMed Identifier
19289689
Citation
Gassner HG, Sherris DA, Friedman O. Botulinum toxin-induced immobilization of lower facial wounds. Arch Facial Plast Surg. 2009 Mar-Apr;11(2):140-2. doi: 10.1001/archfacial.2009.3. No abstract available.
Results Reference
result
PubMed Identifier
16901024
Citation
Gassner HG, Brissett AE, Otley CC, Boahene DK, Boggust AJ, Weaver AL, Sherris DA. Botulinum toxin to improve facial wound healing: A prospective, blinded, placebo-controlled study. Mayo Clin Proc. 2006 Aug;81(8):1023-8. doi: 10.4065/81.8.1023.
Results Reference
result
PubMed Identifier
16651948
Citation
Wilson AM. Use of botulinum toxin type A to prevent widening of facial scars. Plast Reconstr Surg. 2006 May;117(6):1758-66; discussion 1767-8. doi: 10.1097/01.prs.0000209944.45949.d1.
Results Reference
result
PubMed Identifier
19357910
Citation
Xiao Z, Zhang F, Cui Z. Treatment of hypertrophic scars with intralesional botulinum toxin type A injections: a preliminary report. Aesthetic Plast Surg. 2009 May;33(3):409-12. doi: 10.1007/s00266-009-9334-z. Epub 2009 Apr 9.
Results Reference
result
PubMed Identifier
30688903
Citation
Phillips TJ, Fung E, Rigby MH, Burke E, Hart RD, Trites JRB, Gassner HG, Taylor SM. The Use of Botulinum Toxin Type A in the Healing of Thyroidectomy Wounds: A Randomized, Prospective, Placebo-Controlled Study. Plast Reconstr Surg. 2019 Feb;143(2):375e-381e. doi: 10.1097/PRS.0000000000005264.
Results Reference
derived

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Botox in the Healing of Surgical Wounds of the Neck

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