Objective: To determine if the use of botulinum toxin during primary cleft lip repair improves the cosmetic appearance of the cleft lip scar
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
30
Injection of botulinum toxin at the time of surgery at cleft lip repair site. Botulinum toxin will be injected intraoperatively at 4 standardized sites in the cleft lip during surgical repair.
Injection of normal saline into cleft lip at time of surgical repair. Saline will be injected intraoperatively at 4 standardized sites in the cleft lip during surgical repair.
Memorial Hermann Hospital
Houston, Texas, United States
Hypertrophic Scarring (HTS) as Assessed by Score on the Manchester Scar Scale (MSS) Rated by Blinded Plastic Surgeons
The Manchester Scar Scale (MSS) assesses color match to surrounding skin, skin texture, contour, and distortion, and total MSS score ranges from 4 to 14, with a higher score indicating worse scarring. Scars were analyzed by three blinded plastic surgeons, who evaluated frontal and basal photographs of participants. The median of the three surgeon scores per participant was first calculated, and then the median all medians was calculated per arm.
Time frame: 6 months
Hypertrophic Scarring (HTS) as Assessed by Score on the Manchester Scar Scale (MSS) Rated by Blinded Plastic Surgeons
The Manchester Scar Scale (MSS) assesses color match to surrounding skin, skin texture, contour, and distortion, and total MSS score ranges from 4 to 14, with a higher score indicating worse scarring. Scars were analyzed by three blinded plastic surgeons, who evaluated frontal and basal photographs of participants. The median of the three surgeon scores per participant was first calculated, and then the median all medians was calculated per arm.
Time frame: 12 months
Hypertrophic Scarring (HTS) as Assessed by Score on the Modified Scar Rating Scale (MSRS) Rated by Blinded Plastic Surgeons
The Modified Scar Rating Scale (MSRS) assesses surface appearance, scar height, and color mismatch, and total MSRS score ranges from 3 to 12, with a higher score indicating worse scarring. Scars were analyzed by three blinded plastic surgeons, who evaluated frontal and basal photographs of participants. The median of the three surgeon scores per participant was first calculated, and then the median all medians was calculated per arm.
Time frame: 6 months
Hypertrophic Scarring (HTS) as Assessed by Score on the Modified Scar Rating Scale (MSRS) Rated by Blinded Plastic Surgeons
The Modified Scar Rating Scale (MSRS) assesses surface appearance, scar height, and color mismatch, and total MSRS score ranges from 3 to 12, with a higher score indicating worse scarring. Scars were analyzed by three blinded plastic surgeons, who evaluated frontal and basal photographs of participants. The median of the three surgeon scores per participant was first calculated, and then the median all medians was calculated per arm.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 12 months
Hypertrophic Scarring (HTS) as Assessed by Score on the Manchester Scar Scale (MSS) Rated by Crowdsourced Raters
The Manchester Scar Scale (MSS) assesses color match to surrounding skin, skin texture, contour, and distortion, and total MSS score ranges from 4 to 14, with a higher score indicating worse scarring. Scars were analyzed by crowdsourced raters via Amazon Mechanical Turk. The crowdsourced raters evaluated frontal and basal photographs of participants. 100 unique responses were elicited per participant. The mean of all crowdsourced ratings for each arm is reported per arm.
Time frame: 6 months
Hypertrophic Scarring (HTS) as Assessed by Score on the Manchester Scar Scale (MSS) Rated by Crowdsourced Raters
The Manchester Scar Scale (MSS) assesses color match to surrounding skin, skin texture, contour, and distortion, and total MSS score ranges from 4 to 14, with a higher score indicating worse scarring. Scars were analyzed by crowdsourced raters via Amazon Mechanical Turk. The crowdsourced raters evaluated frontal and basal photographs of participants. 100 unique responses were elicited per participant. The mean of all crowdsourced ratings for each arm is reported per arm.
Time frame: 12 months
Hypertrophic Scarring (HTS) as Assessed by Score on the Modified Scar Rating Scale (MSRS) Rated by Crowdsourced Raters
The Modified Scar Rating Scale (MSRS) assesses surface appearance, scar height, and color mismatch, and total MSRS score ranges from 3 to 12, with a higher score indicating worse scarring. Scars were analyzed by crowdsourced raters via Amazon Mechanical Turk. The crowdsourced raters evaluated frontal and basal photographs of participants. 100 unique responses were elicited per participant. The mean of all crowdsourced ratings for each arm is reported per arm.
Time frame: 6 months
Hypertrophic Scarring (HTS) as Assessed by Score on the Modified Scar Rating Scale (MSRS) Rated by Crowdsourced Raters
The Modified Scar Rating Scale (MSRS) assesses surface appearance, scar height, and color mismatch, and total MSRS score ranges from 3 to 12, with a higher score indicating worse scarring. Scars were analyzed by crowdsourced raters via Amazon Mechanical Turk. The crowdsourced raters evaluated frontal and basal photographs of participants. 100 unique responses were elicited per participant. The mean of all crowdsourced ratings for each arm is reported per arm.
Time frame: 12 months