ScarPhase 2NCT01177358
Botox in the Healing of Surgical Wounds of the Neck
A Phase 2 study testing Botulinum Toxin Type A and Normal Saline in people with Scar, run by Nova Scotia Health Authority at 1 site in Canada.
Trial summary
The investigators hypothesize that Botox A will reduce scarring and improve healing of surgical neck wounds. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Scar
- What is being tested?
- Botulinum Toxin Type A and Normal Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 31 May 2010to 5 May 2016
- Phase
- Phase 2
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- all patients referred to the ENT clinic for a thyroidectomy or parathyroidectomy
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Botulinum Toxin A in the Healing of Surgical Wounds of the Neck: a Randomized, Prospective, Placebo-controlled Trial
The investigators hypothesize that Botox A will reduce scarring and improve healing of surgical neck wounds.
Read the 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.
- Conditions
- Scar
- Being tested
- Botulinum Toxin Type A, Normal Saline
- Keywords
- Scar, Botox
- Medical subject headings
- Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Also called Allergan Botox, Drug Identification Number 01981501
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.
Normal SalineDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Botulinum Toxin A injection | Experimental | 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. Receives: Drug: Botulinum Toxin Type A |
| Saline | Placebo comparator | 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. Receives: Drug: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (3)
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.
Measured: 4 weeks
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.
Measured: 6 months
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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2010 (estimated)
- Study start31 May 2010
- Primary completion5 May 2016
- Study completion5 May 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for ScarStudies of the same condition, open and under way.
- More trials run by Nova Scotia Health AuthorityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nova Scotia Health Authority
- Sponsor type
- University, hospital or other
- Collaborators
- Allergan
- Responsible party
- Sponsor
- Investigators
- Mark Taylor, FRCS, Principal investigator, Capital District Health Authority Nova Scotia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01177358
- Sponsor's protocol ID
- BTX-001
- Status last verified
- Oct 2022
- First submitted
- 8 Jul 2010
- Last updated
- 21 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 19289689Gassner 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.
PubMed 16901024Wilson 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.
PubMed 16651948Xiao 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.
PubMed 19357910Phillips 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.
PubMed 30688903
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Botulinum Toxin A in the Healing of Surgical Wounds of the Neck: a Randomized, Prospective, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT01177358
- Acronym / sponsor ID
- BTX-001
- Conditions
- Scar
- Keywords
- Scar, Botox
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Nova Scotia Health AuthorityUniversity, hospital or other
- Collaborators
- Allergan
- Study start
- 31 May 2010 (actual)
- Primary completion
- 5 May 2016 (actual)
- Study completion
- 5 May 2016 (actual)
- First posted
- 9 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Botulinum Toxin A injection | Experimental | Drug: Botulinum Toxin Type AA 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. |
| Saline | Placebo comparator | Drug: Normal Saline0.1 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- all patients referred to the ENT clinic for a thyroidectomy or parathyroidectomy
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Botulinum Toxin Type AAlso: Allergan Botox, Drug Identification Number 01981501A 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. | Drug | Botulinum Toxin A injection |
| Normal Saline0.1mL 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. | Drug | Saline |
Primary outcome
Vancouver Scar Scale
Time frame: 6 months
The surgeon will assess the healing of the surgical incision at 6 months and fill out the Vancouver Scar Scale following the operation.
3 secondary outcomes
Patient and Observer Scar Assessment Scale
Time frame: 4 weeks
Patient and Observer Scar Assessment Scale
Time frame: 6 months
Vancouver Scar Scale
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2024.
- Results publication: PubMed 19289689Gassner 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 publication: PubMed 16901024Gassner 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 publication: PubMed 16651948Wilson 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 publication: PubMed 19357910Xiao 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.
- Derived from this study: PubMed 30688903Phillips 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Taylor, FRCS principal investigator
Capital District Health Authority Nova Scotia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Botulinum Toxin Type A and Normal Saline in people with Scar, run by Nova Scotia Health Authority at 1 site in Canada.
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 1 inclusion and 7 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 21 Aug 2024. 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 Canada. 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 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.
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). 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 NCT01177358, which also lists 5 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 21 Aug 2024.