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Objective: To determine if the use of botulinum toxin during primary cleft lip repair improves the cosmetic appearance of the cleft lip scar
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Botulinum Toxin | Experimental | Injection of botulinum toxin into cleft lip at time of surgical repair. |
|
| Saline | Placebo Comparator | Injection of normal saline into cleft lip at time of surgical repair. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Botulinum Toxin Type A | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
-bilateral cleft lip
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| Name | Affiliation | Role |
|---|---|---|
| Jaecel O Shah, MD | UTHealth | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Hermann Hospital | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19036619 | Background | Pascual-Pascual SI, Pascual-Castroviejo I. Safety of botulinum toxin type A in children younger than 2 years. Eur J Paediatr Neurol. 2009 Nov;13(6):511-5. doi: 10.1016/j.ejpn.2008.10.006. Epub 2008 Nov 25. | |
| 20808741 | Background | Galarraga IM. Use of botulinum toxin in cheiloplasty: A new method to decrease tension. Can J Plast Surg. 2009 Fall;17(3):e1-2. doi: 10.1177/229255030901700313. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Botulinum Toxin | Injection of botulinum toxin into cleft lip at time of surgical repair. Botulinum Toxin Type A: 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. |
| FG001 | Saline | Injection of normal saline into cleft lip at time of surgical repair. Normal Saline Injection: 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Botulinum Toxin | Injection of botulinum toxin into cleft lip at time of surgical repair. Botulinum Toxin Type A: 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Only 9 in the Botulinum Toxin arm and 11 in the Saline arm were analyzed for this outcome measure. | Posted | Median | Inter-Quartile Range | score on a scale | 6 months |
|
12 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Botulinum Toxin | Injection of botulinum toxin into cleft lip at time of surgical repair. Botulinum Toxin Type A: 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. |
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Small sample size; inconsistency in acquiring post-op photos for some; 12 month analysis may be skewed by Botox's short duration of action; crowdsourced raters were not a generalized sample of the population
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Matthew R. Greives, MD | The University of Texas Health Science Center at Houston | 713-500-7275 | Matthew.R.Greives@uth.tmc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 17, 2015 | May 14, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D002971 | Cleft Lip |
| D002921 | Cicatrix |
| D002972 | Cleft Palate |
| ID | Term |
|---|---|
| D008047 | Lip Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D009056 | Mouth Abnormalities |
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| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
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| Normal Saline Injection | Drug | 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. |
|
| 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. | 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. | 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. | 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. | 12 months |
| 19700985 | Background | Alvarez CM, De Vera MA, Chhina H, Williams L, Durlacher K, Kaga S. The use of botulinum type A toxin in the treatment of idiopathic clubfoot: 5-year follow-up. J Pediatr Orthop. 2009 Sep;29(6):570-5. doi: 10.1097/BPO.0b013e3181b2b3d4. |
| 19289689 | Background | 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. |
| 15234303 | Background | Christiansen G, Mohney BG, Baratz KH, Bradley EA. Botulinum toxin for the treatment of congenital entropion. Am J Ophthalmol. 2004 Jul;138(1):153-5. doi: 10.1016/j.ajo.2004.02.023. |
| 11823931 | Background | Sherris DA, Gassner HG. Botulinum toxin to minimize facial scarring. Facial Plast Surg. 2002 Feb;18(1):35-9. doi: 10.1055/s-2002-19825. |
| 11465005 | Background | Sykes JM. Management of the cleft lip deformity. Facial Plast Surg Clin North Am. 2001 Feb;9(1):37-50. |
| 11802349 | Background | Seibert RW. Bilateral cleft nasal repair. Facial Plast Surg. 2000;16(1):69-78. doi: 10.1055/s-2000-7328. |
| 8017808 | Background | Millard DR Jr. Embryonic rationale for the primary correction of classical congenital clefts of the lip and palate. Ann R Coll Surg Engl. 1994 May;76(3):150-60. |
| 8275629 | Background | Witt PD, Hardesty RA. Rotation-advancement repair of the unilateral cleft lip. One center's perspective. Clin Plast Surg. 1993 Oct;20(4):633-45. |
| 23869330 | Background | Lee JS, Lee KB, Lee YR, Choi YN, Park CW, Park SD, Jung DH, Lee CS. Botulinum Toxin Treatment on Upper Limb Function in School Age Children With Bilateral Spastic Cerebral Palsy: One Year Follow-up. Ann Rehabil Med. 2013 Jun;37(3):328-35. doi: 10.5535/arm.2013.37.3.328. Epub 2013 Jun 30. |
| Saline |
Injection of normal saline into cleft lip at time of surgical repair. Normal Saline Injection: 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. |
| BG002 | Total | Total of all reporting groups |
| days |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Number of Participants with Syndromic Cleft Lip | Count of Participants | Participants |
|
| Number of Participants with Presurgical Nasoalveolar Molding (PNAM) | Count of Participants | Participants |
|
| Number of Participants with Complete Cleft Lip | Count of Participants | Participants |
|
| Number of Participants with Unilateral Cleft Lip | Count of Participants | Participants |
|
| Number of Participants with Cleft Palate | Count of Participants | Participants |
|
| OG001 | Saline | Injection of normal saline into cleft lip at time of surgical repair. Normal Saline Injection: 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. |
|
|
| Primary | 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. | Only 9 in the Botulinum Toxin arm and 11 in the Saline arm were analyzed for this outcome measure. | Posted | Median | Inter-Quartile Range | score on a scale | 12 months |
|
|
|
| Primary | 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. | Only 9 in the Botulinum Toxin arm and 11 in the Saline arm were analyzed for this outcome measure. | Posted | Median | Inter-Quartile Range | score on a scale | 6 months |
|
|
|
| Primary | 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. | Only 9 in the Botulinum Toxin arm and 11 in the Saline arm were analyzed for this outcome measure. | Posted | Median | Inter-Quartile Range | score on a scale | 12 months |
|
|
|
| Primary | 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. | Only 9 in the Botulinum Toxin arm and 11 in the Saline arm were analyzed for this outcome measure. | Posted | Mean | Standard Deviation | score on a scale | 6 months |
|
|
|
| Primary | 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. | Only 8 in the Botulinum Toxin arm and 12 in the Saline arm were analyzed for this outcome measure. | Posted | Mean | Standard Deviation | score on a scale | 12 months |
|
|
|
| Primary | 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. | Only 9 in the Botulinum Toxin arm and 11 in the Saline arm were analyzed for this outcome measure. | Posted | Mean | Standard Deviation | score on a scale | 6 months |
|
|
|
| Primary | 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. | Only 8 in the Botulinum Toxin arm and 12 in the Saline arm were analyzed for this outcome measure. | Posted | Mean | Standard Deviation | score on a scale | 12 months |
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | Saline | Injection of normal saline into cleft lip at time of surgical repair. Normal Saline Injection: 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. | 0 | 15 | 0 | 15 | 0 | 15 |
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| D018640 |
| Stomatognathic System Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007569 | Jaw Abnormalities |
| D007571 | Jaw Diseases |
| D009140 | Musculoskeletal Diseases |
| D019767 | Maxillofacial Abnormalities |
| D019465 | Craniofacial Abnormalities |
| D009139 | Musculoskeletal Abnormalities |
| D006867 |
| Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |