The width of upper lip scar was measured by ultrasound, as indicated by the two green crosses. 

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... and March 2012, sixty consecutive patients were enrolled for randomization having satisfied the following criteria. Inclusion criteria were: (1) adult (16 years or older) Oriental Taiwanese patients who desired elective CLSR surgery; (2) moderate-to-severe secondary scar deformity following primary cleft lip repair that warranted revision surgery; (3) valid written informed consent provided for surgery and trial inclusion. All CLSRs were performed at the Craniofacial Center of Chang Gung Memorial Hospital, Taiwan. A specialized nurse, who was independent of the study, prepared the encoded vials. Experimental group vials contained 0.6 ml of normal saline with 15 units of botulinum toxin A (ie. 100 units of botulinum toxin A per 4 ml of normal saline; Botox, Allergen Inc, Irvine, California). Vehicle-control group vials contained 0.6 ml of normal saline. All vials appeared identical except for their randomization code and patient identification. Patients were block randomized to a 1:1 ratio by an independent third-party specialized trials nurse into the experimental or vehicle-control group. Randomization codes were not revealed to anyone until after completion of the entire study. Patients, investigators, study personnel and outcomes assessors therefore remained blinded throughout the investigation (Fig. 2)(S1 Checklist). The lip scar was revised using a modified rotation advancement cheiloplasty as previously described [8]. Briefly, the scar of the lip and nasal floor was marked and the scar tissue narrowly excised. The orbicularis oris muscle was excised wider than the width of scar; this maneuver reduces tension across the overlying skin repair, since the muscle repair causes slight redundancy of the skin. The first stitch taking lateral orbicularis muscle was sutured to the nasal septum; thereafter, the lateral orbicularis muscle was interposed and sutured overlapping the medial orbicularis muscle for philtral column reconstruction. Interrupted sutures used were as follows: 4–0 and 5–0 polydioxanone (PDS II; Ethicon/Johnson-Johnson, New Brunswick, New Jersey) for muscle and subcuticular layers, respectively; 6-0 nylon (Unik, Taipei, Taiwan) for skin [8]. Immediately after skin closure, six injections of encoded vial content (0.1 ml for each injection site) were administered to the orbicularis oris muscle 5 mm either side of the wound below the nasal base and above the vermillion border (Fig. 3). Nylon sutures were removed six days postoperatively. To reduce wound tension caused by the adjacent risorius, zygomaticus major and zygomaticus minor muscles, both cheeks and the upper lip suture line were taped as per our routine for 6 months. Additionally, silicone sheeting was applied overnight as per our routine for 6 months. Compliance with both practices was consistent for all patients. All complications, such as hematoma, infection, wound dehiscence, oral incompetence, eating/drinking dysfunction and drug allergy, were logged if encountered. Primary and secondary end points were Vancouver scar scale (VSS) score (comprising the following components: pigmentation, vascularity, pliability and scar height), Visual analogue scale (VAS) and scar width, respectively. At six months follow-up, two plastic surgeons (PKTC and CSC) examined the patients in the outpatient clinic of Chang Gung Memorial Hospital. They were blinded to which group patients belonged. Scars were assessed using the VSS and assigned the mean score of the two observers. For photographs, one standard surgical ruler was placed over the lower lip and a frontally orientated photograph of the patient was taken at 6-months follow up. The same professional craniofacial medical photographer took all photographs. Patient’s photographs were subjectively assessed using VAS by five independent examiners (two Attending Plastic Surgeons and three laypersons). All examiners were both independent of the patients’ care and blinded to their treatments. They were asked to score the scars on the photographs using a standard Visual Analogue Scale (VAS) graded from 0 (worst possible scar) to 10 (best possible scar). Objective scar width measurements were performed using photography and ultrasonography. The scar was measured at two points with Photoshop (CS5 extended version 12.0; Adobe Systems Inc, San Jose, California) using the ruler as a control reference. The First Point was 1 mm above the white roll and the Second Point was 1 mm below the turning incision line, which is located close to the nasal sill (Fig. 4). The scar measurement was measured by two plastic surgeons and averaged. A commercial 12-MHz ultrasound transducer and imager (Model T3000; Terason, Northborough, MA, USA; settings: depth of penetration, 20 mm; capacity of ultrasound imager, 0.1 mm) was also used to quantify scar width. The transducer was placed with its upper border touching the columella-philtral junction, upper lip imaging was obtained and the scar width measured at the skin surface (Fig. 5). The ultrasound measurement was performed by the lead author (CSC) in duplicate and averaged. Inter-observer reliability of the VSS and VAS were tested using Cronbach a . Inter- observer reliability of photographic measurements was assessed with Pearson correlation by comparing two sets of measurements performed by two independent raters. Intra-observer reliability of ultrasound measurements was assessed with Pearson correlation by comparing two sets of measurements performed by the same rater. All statistical analyses were conducted using SPSS software (version 17.0; IBM Corporation, NY, USA). Differences between VSS scores, VAS and between scar widths obtained photographically and ultrasonographically were compared. The independent t-test was used to compare groups. Statistical significance was defined if p was less than 0.05. Data are presented as mean ¡ standard deviation unless otherwise stated. Thirty patients in the experimental group received botulinum toxin injections and thirty patients in the vehicle-control group received normal saline injections, as described, immediately after completion of CLSR. Fifty-eight patients completed six months of follow-up; two patients in the vehicle-control group failed to return for postoperative assessments. No complications were encountered (S1 Data). The mean ages for the experimental group and vehicle-control group were 24.70 ¡ 7.16 versus 21.87 ¡ 8.00. There were 12 males and 18 females with 20 left and 10 right cleft lips in the experimental group. There were 14 males and 14 females with 20 left and 8 right cleft lips in the vehicle control group. The VSS score for the experimental group was significantly lower than that of the vehicle-control group (2.45 ¡ 1.52 versus 3.50 ¡ 1.88; p 5 0.023). Inter- observer consistency in using the VSS score was high (Cronbach a 5 0.936). The VAS score in the experimental group was significantly better than in the vehicle-control group (7.47 ¡ 0.64 versus 6.10 ¡ 1.06; p , 0.001). Inter-observer consistency was high (Cronbach a 5 0.923) According to photographic measurements, the scar was significantly narrower at both the First Point (0.62 ¡ 0.18 mm versus 0.95 ¡ 0.31 mm; p , 0.001) and the Second Point (0.63 ¡ 0.18 mm versus 0.92 ¡ 0.36 mm; p , 0.001) in the experimental than in the vehicle-control group. Inter-observer consistency was high for the photographic data (First Point: r 5 0.87, p , 0.001; Second Point: r 5 0.88, p , 0.001). This was also the case according to ultrasonographic measurements (0.72 ¡ 0.25 mm versus 1.03 ¡ 0.42 mm for experimental and vehicle-control groups respectively; p 5 0.001). Intra-observer consistency was high for the ultrasonographic data (r 5 0.90, p , 0.001). Facial scars can be cosmetically disfiguring and may, in some patients, cause functional impairment and psychosocial withdrawal [9, 10]. Cutaneous scars are generally distinguished from surrounding normal skin by differences in color, thickness, contour, compliance, overall cosmesis and functional detriments such as contracture formation. Young et al found that patients were usually dissatisfied with their surgical scars, irrespective of patient gender, age, ethnicity or geographical location, and that 91% of them would value even a small improvement in their scar [3]. Hence, surgeons frequently recommend and prescribe scar modulation practices and treatments, particularly in susceptible ethnicities such as Orientals for whom the incidence of unfavorable scarring is higher than in Caucasians [11]. Synergistic contractions of the facial muscles are responsible for facial expressions. Since these muscles do not have bony insertions and lie very superficially, their actions exert tension across adjacent skin and subcutaneous tissue. If a wound is orientated perpendicular to the direction of the underlying facial muscle fibers, the muscular tension exerts a distracting effect on the healing wound edges and increases the risk of an undesirable hypertrophic or widened scar (Fig. 1). Consequently, reducing tension around a wound is important for improving scar quality and reducing the incidence of hypertrophic scars [12, 13]. A secondary cleft lip deformity is one that arises despite primary surgical treatment of the cleft lip. The principles of CLSR are cleft scar excision, anatomical repair of the orbicularis oris muscle, and correction of asymmetries noted in the Cupid bow and philtral columns. Unfortunately, CLSR wounds are unavoidably orientated perpendicular to the line of pull of the subjacent orbicularis oris muscle, which is in constant use during daily life for speech, eating, drinking, blowing, sucking, and a variety of facial expressions. These repetitive bouts of distracting tensional forces inflict micro-trauma to the healing wound, leading to prolongation of the inflammatory response and ultimately increased fibrosis [14]. In contrast to other facial wounds, the incidence of hypertrophic scars affecting the ...