Fischer Dagmar-C, Sckell Axel, Garkisch Angelina, Dresing Klaus, Eisenhauer Anton, Valentini Luzia, Mittlmeier Thomas
Department of Pediatrics, Rostock University Medical Center, Ernst-Heydemann-Str. 8, 18057, Rostock, Germany.
Department of Traumatology, Hand and Reconstructive Surgery, Rostock University Medical Center, Rostock, Germany.
Pilot Feasibility Stud. 2021 Nov 12;7(1):203. doi: 10.1186/s40814-021-00944-7.
Edema is commonly seen after surgical fixation of ankle fractures. Rest, ice, compression, and elevation (RICE) is an established combination to prevent swelling but hardly able to stimulate lymphatic resorption. Recently, an epicutaneously applied negative pressure suction apparatus (LymphaTouch®) has been introduced to stimulate lymphatic flow. While postoperative recovery, soft tissue, and osseous healing as well as functional outcome are probably linked to the amount of postoperative swelling, estimates on this relative to prevention (RICE) or prevention + stimulated resorption (RICE) of fluid are scarce.
This is a single-center, evaluator-blinded randomized pilot trial to investigate postoperative swelling in adults requiring surgical fixation of a closed unilateral ankle fracture. A total of 50 patients will be recruited and randomly assigned to RICE or RICE prior to surgery. All patients will undergo evaluator-blinded measurements of the ankle volume the day before surgery and subsequently from the evening of the 2nd postoperative day every 24 h until discharge. RICE will be initiated right after surgery and continued until discharge from the hospital in all patients. Additional application of negative pressure therapy (RICE) will be initiated on the morning of the 2nd postoperative day and repeated every 24 h until the time of discharge from the hospital. Outcome measures are (i) the relative amount and the time course of the postoperative swelling, (ii) the demand for analgesic therapy (type and amount) together with the perception of pain, (iii) the rate of complications, and (iv) mobility of the ankle joint and the recovery of walking abilities during a 12-weeks follow-up period. Serum and urine samples taken prior to sugery and during postoperative recovery will allow to evaluate the ratio of naturally occurring stable calcium isotopes (δCa) as a marker of skeletal calcium accrual.
The protocol was approved by the institutional Ethics Committee (Rostock University Medical Center, Rostock, Germany) in accordance with the Declaration of Helsinki (approval number: A 2020-0092). The results of this study will be actively disseminated through scientific publications and conference presentations.
DRKS, DRKS00023739 . Registered on 14 December 2020.
踝关节骨折手术固定后常出现水肿。休息、冰敷、加压包扎和抬高患肢（RICE）是预防肿胀的常用方法，但很难促进淋巴吸收。最近，一种经皮应用的负压吸引装置（LymphaTouch®）已被用于促进淋巴流动。虽然术后恢复、软组织和骨愈合以及功能结果可能与术后肿胀程度有关，但相对于预防（RICE）或预防加液体吸收促进（RICE）的术后肿胀程度估计却很少。
这是一项单中心、评估者盲法的随机试点试验，旨在研究需要手术固定闭合性单侧踝关节骨折的成年人术后肿胀情况。共招募50名患者，随机分为RICE组或术前RICE组。所有患者将在手术前一天接受评估者盲法测量踝关节体积，随后从术后第2天晚上开始，每24小时测量一次，直至出院。所有患者术后立即开始RICE治疗，并持续至出院。术后第2天上午开始额外应用负压治疗（RICE），每24小时重复一次，直至出院。观察指标包括：（i）术后肿胀的相对程度和时间进程；（ii）镇痛治疗的需求（类型和剂量）以及疼痛感受；（iii）并发症发生率；（iv）在12周随访期内踝关节的活动度和步行能力恢复情况。术前和术后恢复期间采集的血清和尿液样本将用于评估天然存在的稳定钙同位素（δCa）的比值，作为骨骼钙积累的标志物。
该方案已获得机构伦理委员会（德国罗斯托克大学医学中心，罗斯托克）根据《赫尔辛基宣言》的批准（批准号：A 2020-0092）。本研究结果将通过科学出版物和会议报告积极传播。
DRKS，DRKS00023739。于2020年12月14日注册。
