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Title: [Randomized controlled trial on application of negative pressure materials of polyvinyl alcohol and polyurethane in full-thickness burn wounds after escharotomy].
Author: Huang Z, Wang P, Pan ZY, Dong L, Su J, Xu NW.
Journal: Zhonghua Shao Shang Za Zhi; 2020 Sep 20; 36(9):813-820. PubMed ID: 32972066.
Abstract:
Objective: To compare the effects and characteristic difference of negative pressure materials of polyvinyl alcohol and polyurethane in the treatment of full-thickness burn wounds after escharotomy. Methods: From January 2018 to December 2019, 60 patients with full-thickness burns who met the inclusion criteria and hospitalized in Xuzhou Renci Hospital were recruited in this prospective randomized controlled trial. According to the random number table, 60 cases were divided into polyvinyl alcohol group (n =30, 13 males and 17 females) and polyurethane group (n =30, 14 males and 16 females), aged (34±7) and (35±6) years respectively, with burn area of 4.20% (2.23%, 4.90%) total body surface area (TBSA) and 3.89% (2.18%, 4.76%)TBSA and escharectomy area of 2.70% (1.97%, 3.42%) TBSA and 2.87% (2.12%, 3.34%)TBSA, respectively. After patient's admission, debridement was immediately performed on the full-thickness burn wound, and the dressing was changed with iodophor once a day. Escharectomy was performed on post injury day 3. After thorough hemostasis and washing the wounds with normal saline, patients of the two groups chose corresponding foam materials and supporting facilities for continuous negative-pressure treatment for 1 week, with the negative pressure value setting at -19.9 kPa. Installation time of negative-pressure material was recorded. After a week of negative-pressure treatment, the maximum pulling force of removing foam material was recorded to evaluate the adhesional degree between foam materials and wounds. The amount of bleeding in the process of removing foam materials was recorded, hyperplasiaof granulation tissue was observed with hematoxylin eosin (HE) staining, and the expression of CD31 was detected by immunohistochemical staining and Western blotting to denote vascularization. The ratio of R1 to R0 of coefficient of restitution of foam material before and one week after negative-pressure treatment and drainage volume of wound exudate within a week of negative-pressure treatment were recorded to denote the drainage ability of foam material to wound exudate. One week after negative-pressure treatment, the bacterial colonization, residual foreign body, and eczema rate of skin edge were recorded. Data were statistically analyzed with chi-square test, independent-sample t test, and Mann-Whitney U test. Results: (1) Installation time of negative-pressure material of patients in polyurethane group was (14±3) min, which was significantly shorter than (18±3) min in polyvinyl alcohol group (t=2.788, P<0.01). (2) One week after negative-pressure treatment, the maximum pulling force of removing foam material of patients in polyvinyl alcohol group was (6.4±0.4) N, which was significantly lower than (16.7±0.8) N in polyurethane group (t=12.010, P<0.01). (3) One week after negative-pressure treatment, the volume of wound bleeding of patients in polyvinyl alcohol group was (20±3) mL in the process of removing foam material, which was significantly less than (59±3) mL in polyurethane group (t=50.200, P<0.01). (4) One week after negative-pressure treatment, HE staining showed that hyperplastic thickness of wound granulation tissue of patients in polyurethane group was (2.3±0.6) mm which was significantly higher than (1.6±0.4) mm in polyvinyl alcohol group ( t=6.667, P<0.01); immunohistochemical staining showed that the number of microvascular lumen in wound granulation tissue of patients in polyurethane group was significantly more than that in polyvinyl alcohol group; Western blotting showed that protein expression of CD31 in wound granulation tissue of patients in polyurethane group (1.00±0.05) was significantly higher than 0.42±0.03 of polyvinyl alcohol group (t=10.490, P<0.01). (5)The ratio of R1 to R0 of coefficient of restitution of foam material of patients in polyvinyl alcohol group was 0.39±0.19, which was significantly lower than 0.52±0.16 in polyurethane group (t=2.975, P<0.01). In patients of polyvinyl alcohol group, the drainage volume of wound exudate of foam material during one week after negative-pressure treatment was (1 258±444) mL, significantly less than (1 658±580) mL of polyurethane group (t=3.003, P<0.01). (6) One week after negative-pressure treatment, the number of residual foreign body in wounds of patients of polyurethane group was (14.14±0.37) particles, which was significantly more than (3.36±0.15) particles in polyvinyl alcohol group (t=26.200, P<0.01). The level of bacterial colonization of wounds and eczema rate of skin edge of patients between the two groups were close. Conclusions: Polyurethane foam material is easy to install and operate, relatively difficult to dry and shrink, and has strong ability to discharge wound exudation. Polyurethane foam material is better than polyvinyl alcohol foam material in promoting wound angiogenesis and tissue proliferation. Polyurethane foam material can be chosen firstly for the wounds with need of protecting deep tissues and important organs, as well as the wounds with obvious inflammatory edema and serious contamination. Polyvinyl alcohol foam material is less adherent to wounds, which is better than polyurethane foam material in the aspects of reducing wound bleeding and residual foreign body. Polyvinyl alcohol foam material can be firstly selected to fix and promote skin graft survival after skin grafting, wound bed preparation before skin grafting of burn with large area and deep wound cavity or sinus, etc. Both types of foam materials need to be improved in the aspects of bacterial colonization and prevention and treatment of skin eczema. 目的： 对比聚乙烯醇和聚氨酯负压材料用于治疗Ⅲ度烧伤切痂创面的效果与特性差异。 方法： 选择2018年1月—2019年12月徐州仁慈医院收治的符合入选标准的60例Ⅲ度烧伤患者，进行前瞻性随机对照试验。按照随机数字表法分为聚乙烯醇组(男13例、女17例)和聚氨酯组(男14例、女16例)各30例，年龄分别为(34±7)、(35±6)岁，烧伤总面积分别为4.20%(2.23%，4.90%)、3.89%(2.18%，4.76%)体表总面积(TBSA)、切痂面积分别为2.70%(1.97%，3.42%)、2.87%(2.12%，3.34%)TBSA。患者入院后立即对Ⅲ度烧伤创面行清创术，每日碘伏换药1次。伤后第3天行切痂术，彻底止血并用生理盐水冲洗创面后，2组患者分别选取相应的泡沫材料及配套设备行负压治疗，负压值设置为-19.9 kPa，持续负压治疗1周。记录负压材料安装时间。负压治疗1周，记录去除泡沫材料的最大拉力，评估泡沫材料与创面的粘连度；记录去除泡沫材料过程中创面出血量；苏木精-伊红(HE)染色观察创面肉芽组织增生情况，免疫组织化学染色及蛋白质印迹法检测CD31表达反映血管化情况。检测泡沫材料负压治疗1周与使用前的回弹系数R1/R0比值，记录负压治疗1周内创面渗液引流量，以此表示泡沫材料对创面渗液的引流能力。负压治疗1周，记录创面细菌定植情况、异物残留情况、皮缘湿疹率。对数据行χ(2)检验、独立样本t检验、Mann-Whitney U检验。 结果： (1)聚氨酯组患者的负压材料安装时间为(14±3)min，明显短于聚乙烯醇组的(18±3)min(t＝2.788, P<0.01)。(2)负压治疗1周，聚乙烯醇组患者去除泡沫材料的最大拉力为(6.4±0.4)N，明显低于聚氨酯组的(16.7±0.8)N(t＝12.010, P<0.01)。(3)负压治疗1周，去除泡沫材料过程中，聚乙烯醇组患者的创面出血量为(20±3)mL，明显少于聚氨酯组的(59±3)mL(t＝50.200，P<0.01)。(4)负压治疗1周，HE染色显示，聚氨酯组患者创面肉芽组织增生厚度为(2.3±0.6)mm，明显高于聚乙烯醇组的(1.6±0.4)mm(t＝6.667, P<0.01)。负压治疗1周，免疫组织化学染色显示，聚氨酯组患者创面肉芽组织中的微血管管腔数量明显多于聚乙烯醇组；蛋白质印迹法显示，聚氨酯组患者创面的肉芽组织中CD31蛋白表达量(1.00±0.05)亦明显高于聚乙烯醇组(0.42±0.03，t＝10.490, P<0.01)。(5)聚乙烯醇组患者泡沫材料回弹系数R1/R0比值为0.39±0.19，明显低于聚氨酯组的0.52±0.16(t＝2.975, P<0.01)。负压治疗1周内，聚乙烯醇组患者泡沫材料创面渗液引流量为(1 258±444)mL，明显少于聚氨酯组的(1 658±580)mL( t＝3.003, P<0.01)。(6)负压治疗1周，聚氨酯组患者创面的异物颗粒残留数量为(14.14±0.37)个，明显多于聚乙烯醇组的(3.36±0.15)个(t＝26.200，P<0.01)；2组患者的创面细菌定植水平、皮缘湿疹率相近。 结论： 聚氨酯泡沫材料安装操作方便，相对不易干结皱缩，引流创面渗液能力强，在促进创面血管化和组织增生方面优于聚乙烯醇泡沫材料；对需要保护深部组织、重要器官的创面及炎性水肿明显、污染严重的创面可优先选择该材料。聚乙烯醇泡沫材料不易与创面粘连，减少创面出血和异物残留方面优于聚氨酯泡沫材料；在创面植皮术后固定促使皮片成活、大面积烧伤植皮术前创面床准备及存在深部创腔或窦道等情况下可优先选择该材料。2种泡沫材料在细菌定植和皮肤湿疹防治方面均有待改进。.

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