Ignite Creation Date:
2024-05-06 @ 3:47 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04756882
Status:
UNKNOWN
Last Update Posted:
2021-02-16
First Post:
2021-02-07
Brief Title:
Clinical Evaluation of the Efficacy OF Botulinum Toxin A for Improving Facial Scars
Sponsor:
Alexandria University
Organization:
Alexandria University
Study Overview
Official Title:
Clinical Evaluation of the Efficacy OF Botulinum Toxin A for Improving Facial Scars Randomized Clinical Trial
Status:
UNKNOWN
Status Verified Date:
2021-02
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background Scars widen when the overlying musculature pulls apart suture lines Because Botulinum Toxin A BTA is known to prevent fibroblast proliferation and it also induces temporary muscle paralysis the purpose of this current study is to evaluate the beneficial effects of Botulinum toxin type A BTA on scar formation
Aim of this study The aim of this study is to evaluate the efficacy and safety of early postoperative Botulinum Toxin type A BTA injection on improving vertical or oblique facial surgical scars
Materials and methods Patients with vertical or oblique forehead lacerations treated by primary closure will be enrolled in this study and randomized into two groups One group n 6 will receive BTA injection within 5 days of primary closure and the other group n 6 will receive no further treatment Vancouver scar scale VSS Scores and wound width will be determined at the 1 3 and 6 months follow-up visits along with clinical photographs
Results Data will be collected tabulated and statically analyzed Key words Botulinum Toxin Type A facial scarring wound healing scar maturation
Aim of this study The aim of this study is to evaluate the efficacy and safety of early postoperative Botulinum Toxin type A BTA injection on improving vertical or oblique facial surgical scars
Materials and methods Patients with vertical or oblique forehead lacerations treated by primary closure will be enrolled in this study and randomized into two groups One group n 6 will receive BTA injection within 5 days of primary closure and the other group n 6 will receive no further treatment Vancouver scar scale VSS Scores and wound width will be determined at the 1 3 and 6 months follow-up visits along with clinical photographs
Results Data will be collected tabulated and statically analyzed Key words Botulinum Toxin Type A facial scarring wound healing scar maturation
Detailed Description:
1 All procedures were performed under local anesthesia in Oral and Maxillofacial Surgery Department Alexandria University
2 Using nonalcoholic solution after makeup removal a single surgeon performed the procedures under complete aseptic technique Lee Min et al 2018
3 All patients wore a disposable cap to contain hair
4 We examined before treatment the facial anatomy mimic muscular contraction facial expression and any pre-existing asymmetryWilson 2006
5 Immediately after taking the photographs both the length and width of the forehead wound were measured directly on the patients using a digital vernier caliper by a single plastic surgeon blinded to the study condition
6 Pain at the injected sites was minimized before each injection by applying topical anesthetics and cold iced devices
7 Micro fine 10 ml insulin syringes with a 29-G or 30-G needle were used
8 The dosages of the preparations are related to biological activity and are given in biological units U The units are termed according to the manufacturer as Speywood U SU for Dysport
9 The drugs used were AboBotulinumToxin A Dysport 500 Speywood U is to be reconstituted with 20 mL of sodium chloride 9 mgmL 09 injection solution This results in a clear solution containing the 500 Speywood units of the active ingredient in a concentration of 250 units per 10 mL of the reconstituted solution The reconstitution is to be performed in accordance with the rules of good clinical practice particularly with respect to asepsis and within 15 day of reconstitutinHexsel Rutowitsch et al 2009 Scaglione 2016 Lee Min et al 2018
10 The total dose is approximately 105 SU
11 The total dose is divieded into 75 SU injected by a 1-ml 30-gauge needle insulin syringe along the scar length at the rate of approximately 125 SU 015 ml per cm of wound length in a linear pattern on either side of the wound with the needle prick positined approximately 5 mm from the edge of the wound The injection was repeated every cm throughout the entire wound length and 30 SU are injected into frontalis muscleWilson 2006 Hu Zou et al 2018 Kim Lee et al 2019
12 Injections were determined by a skin marker and done under the supervision of a qualified licensed supervisor
13 due to muscles contraction The injections were carried out on skin folds and are performed at different levels intramuscular subcutaneous or intradermal in more points for each region The injections were administrated directly into the point of intense muscular contraction On the other hand where the contraction was weak the injection was done at a deep or superficial intradermal level Depth depends also on the effect we want to achieve an extreme effect for intramuscular a soft effect for subcutaneous or intradermalIozzo Tengattini et al 2014
14 To prevent eyebrow ptosis the drugs were not injected around the supraorbital rimKim Lee et al 2019
2 Using nonalcoholic solution after makeup removal a single surgeon performed the procedures under complete aseptic technique Lee Min et al 2018
3 All patients wore a disposable cap to contain hair
4 We examined before treatment the facial anatomy mimic muscular contraction facial expression and any pre-existing asymmetryWilson 2006
5 Immediately after taking the photographs both the length and width of the forehead wound were measured directly on the patients using a digital vernier caliper by a single plastic surgeon blinded to the study condition
6 Pain at the injected sites was minimized before each injection by applying topical anesthetics and cold iced devices
7 Micro fine 10 ml insulin syringes with a 29-G or 30-G needle were used
8 The dosages of the preparations are related to biological activity and are given in biological units U The units are termed according to the manufacturer as Speywood U SU for Dysport
9 The drugs used were AboBotulinumToxin A Dysport 500 Speywood U is to be reconstituted with 20 mL of sodium chloride 9 mgmL 09 injection solution This results in a clear solution containing the 500 Speywood units of the active ingredient in a concentration of 250 units per 10 mL of the reconstituted solution The reconstitution is to be performed in accordance with the rules of good clinical practice particularly with respect to asepsis and within 15 day of reconstitutinHexsel Rutowitsch et al 2009 Scaglione 2016 Lee Min et al 2018
10 The total dose is approximately 105 SU
11 The total dose is divieded into 75 SU injected by a 1-ml 30-gauge needle insulin syringe along the scar length at the rate of approximately 125 SU 015 ml per cm of wound length in a linear pattern on either side of the wound with the needle prick positined approximately 5 mm from the edge of the wound The injection was repeated every cm throughout the entire wound length and 30 SU are injected into frontalis muscleWilson 2006 Hu Zou et al 2018 Kim Lee et al 2019
12 Injections were determined by a skin marker and done under the supervision of a qualified licensed supervisor
13 due to muscles contraction The injections were carried out on skin folds and are performed at different levels intramuscular subcutaneous or intradermal in more points for each region The injections were administrated directly into the point of intense muscular contraction On the other hand where the contraction was weak the injection was done at a deep or superficial intradermal level Depth depends also on the effect we want to achieve an extreme effect for intramuscular a soft effect for subcutaneous or intradermalIozzo Tengattini et al 2014
14 To prevent eyebrow ptosis the drugs were not injected around the supraorbital rimKim Lee et al 2019
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None