Sproat J E, Dalcin A, Weitauer N, Roberts R S
Department of Surgery, Hamilton General Hospital, Ont., Canada.
Plast Reconstr Surg. 1992 Dec;90(6):988-92.
A prospective, randomized trial was designed to compare the standard Kenalog injection of established hypertrophic sternal scars with topical silicone gel sheets (Spenco). Fourteen poststernotomy cardiac patients with symptomatic scars were randomized to treatment in one-half of the scar with Kenalog injection. Simultaneously, the other half of the scar received the silicone gel sheet. The standard Kenalog injection used was 40 mg/ml x 1 cc, mixed with 1 cc of 1% Xylocaine with epinephrine. The gel sheets were worn continuously for 12 hours for 12 weeks. Pretreatment and posttreatment photographs were compared for color and appearance by blindfolded observers. Scar measurements (length, width, and height) were taken weekly in each area, and the patients were asked to rank their symptoms within each half as worse, the same, or better. The primary outcome of patient preference was analyzed sequentially, and the recruitment was terminated after 11 patients had completed the study, 10 of whom favored the silicone gel treatment (p < 0.05). Three patients remained in the treatment phase at the time of termination and completed the study subsequently. For the total sample of 14 subjects, 11 preferred the silicone gel, 1 expressed no preference, and 2 preferred the injection. The average time to improvement was 3.9 +/- 0.62 days (gel) versus 6.8 +/- 1.86 days (Kenalog). This study demonstrates that silicone gel sheets provide earlier symptomatic relief and a more aesthetic scar and are the preferred treatment of patients with symptomatic hypertrophic sternal scars.
一项前瞻性随机试验旨在比较已形成的肥厚性胸骨瘢痕的标准曲安奈德注射与外用硅胶片(Spenco)的效果。14例胸骨切开术后有症状瘢痕的心脏患者被随机分为两组,瘢痕的一半接受曲安奈德注射治疗。同时,瘢痕的另一半使用硅胶片。所用的标准曲安奈德注射剂为40mg/ml×1cc,与1cc含肾上腺素的1%利多卡因混合。硅胶片连续佩戴12小时,共12周。由蒙着眼睛的观察者比较治疗前和治疗后的照片,观察颜色和外观。每周测量每个区域瘢痕的长度、宽度和高度,并要求患者对瘢痕两半部分的症状进行排序,分为更差、相同或更好。对患者偏好这一主要结果进行序贯分析,在11例患者完成研究后终止招募,其中10例患者更倾向于硅胶治疗(p<0.05)。终止研究时有3例患者仍处于治疗阶段,随后完成了研究。在14名受试者的总样本中,11人更喜欢硅胶片,1人无偏好,2人更喜欢注射治疗。改善的平均时间为3.9±0.62天(硅胶片),而曲安奈德为6.8±1.86天。这项研究表明,硅胶片能更早地缓解症状,使瘢痕更美观,是有症状的肥厚性胸骨瘢痕患者的首选治疗方法。