Nhiễm trùng vết mổ, dùng cho các trường hợp bỏng, cấy ghép da, vết thương cấp tính, mãn tính, điều trị vết loét tiểu đường, loét tĩnh mạch. Loét xạ trị, Lazer. Loét do bỏng nặng Loét do bệnh lý mạch máu Loét sâu một phần hay toàn phần Vết thương do chấn thương lâu lành Nằm liệt, ngồi lâu ngày gây nên lỡ loét Vết mổ nhiễm trùng, vết phẫu thuật hậu môn Áp dụng cho việc hồi phục vết thương giữa giai đoạn thứ hai và thứ ba Loét chân, vết thương ở chân lâu lành do biến chứng của đái tháo đường (tiểu đường)
International Journal of Surgery 52 (2018) 229–232 Contents lists available at ScienceDirect International Journal of Surgery journal homepage: www.elsevier.com/locate/ijsu Original Research The clinical application of a silicate-based wound dressing (DermFactor®) for wound healing after anal surgery: A randomized study T Shuo Chena,1, Zhiguang Huanb,1, Lin Zhanga,∗, Jiang Changb,∗∗ a Department of Anorectal Surgery, Tianjin Union Medicine Centre, 190 Jieyuan Road, Tianjin 300121, China State Key Laboratory of High Performance Ceramics and Superfine Microstructure, Shanghai Institute of Ceramics, Chinese Academy of Sciences, 1295 Dingxi Road, Shanghai 200050, China b A R T I C L E I N F O A B S T R A C T Keywords: Silicate-based wound dressing DermFactor® Anal surgery Wound healing Background: The object of the present study is to evaluate the feasibility of a silicate-based wound dressing (DermFactor®) in treating the wound of the patients after anorectal surgery Materials and Methods: The present study included 328 patients who received anal surgery during the period from March 2013 to June 2015 The patients were randomized to groups The patients (n = 162) in the control group received conventional dressing therapy, while those in the observation group (n = 166) were treated with the combination of conventional dressing therapy and the use of a silicate-based wound dressing (DermFactor®) The wound healing outcomes of the two groups were observed and compared with each other by statistical analysis Results: The average healing cycles in the observation group were 19.04 days for combined hemorrhoid patients, 23.72 days for anal fistula patients and 21.14 days for anal fissure patients, respectively, which were shorter than those in the control group (23.25 days for mixed hemorrhoid patients, 27.76 days for anal fistula patients and 24.32 days for fissure in ano patients, respectively) In addition, the observation group presented a significantly higher effective rate (80.4%) than the control group (70.4%) Conclusion: Our data demonstrated that the wound after anorectal surgery could be more effectively treated by using silicate-containing DermFactor® Introduction Anal diseases, including hemorrhoid, anal fistula and anal fissure, is common all over the world and affecting people in all age groups [1,2] The patients suffering from these diseases frequently require surgical treatment, and the post-operative care has been considered as one of the most important factors that determine the cosmetic and functional outcome of the anal organ [3] Wound healing is an essential step during the procedure of postoperative care after anal surgery [3] For example, it is believed that a desirable wound healing could help reduce the post-operative pain after haemorrhoidectomy, which quite commonly causes delayed patient discharge [4] However, due to the unusual circumstance, the wound healing after anal surgery is frequently delayed by postoperative complications, such as bleeding, infection and edema, despite the use of wound healing cream Therefore, it is still necessary to investigate more efficient therapeutic regimen to accelerate the postoperative wound healing after anal surgery DermFactor® is a silicate-based wound dressing that has been widely used for wound treatment in cases of burn, diabetic foot and bedsore [5], and its bioactive effect on wound healing is based on the fact that silicate materials can stimulate the vascularization that is essential for healing of soft tissue [6] This important feature makes DermFactor® a potential candidate as a wound dressing to accelerate wound healing during the postoperative care after anal surgery Therefore, during the period from March 2013 to June 2015, DermFactor® was used to treat 166 patients, who received anal surgery, aiming at improving the wound healing This study presented the clinical outcome of the application of DermFactor® as wound dressing for anal surgery, and also evaluated its benefit in terms of wound healing rate and efficiency ∗ Corresponding author Corresponding author E-mail addresses: xz2013l@126.com (L Zhang), jchang@mail.sic.ac.cn (J Chang) The two authors contributed to the work equally ∗∗ https://doi.org/10.1016/j.ijsu.2018.02.036 Received 30 August 2017; Received in revised form February 2018; Accepted 14 February 2018 Available online 23 February 2018 1743-9191/ © 2018 IJS Publishing Group Ltd Published by Elsevier Ltd All rights reserved International Journal of Surgery 52 (2018) 229–232 S Chen et al ― The treatment was considered to be “effective” (E) if the cured part of the wound surface area amounted to at least 50% of the overall wound surface ― It was noted as “improved” if 30%–50% of the wound was cured (IMP) ― It was noted as “ineffective” (INE) if the cured part of wound was less than 30% Materials and Methods 2.1 Patients This study included 328 patients who received anal surgery at our hospital from March 2013 to June 2015 The selection of the patient was based on the following criteria: The patients suffered from mixed hemorrhoid, anal fistula or fissure in ano before receiving anal surgery The patients were not allergic to any drug that was involved in this study, and those suffering from serious mental sickness and hematological diseases were excluded In addition, pregnant and lactating patients were not included in this study The ages of all the selected patients in this study were over 18 years old All the patients were fully informed before voluntarily attending this study with the informed consent signed precedent to the treatment The patients (n = 328) randomized to groups The patients (n = 162) in the control group received conventional dressing therapy, while those in the observation group (n = 166) were treated with the combination of conventional dressing therapy and the use of DermFactor® (Shanghai Gui-Jian Biomaterials Co., Ltd, Shanghai, China) The patients' brief data was summarized and presented in Table The patient's data of the control group did not show significant difference from that of the observation group, which allowed for reasonable comparison between the groups The total effective rate (Et) was calculated according to Eq (1): Et (%) = NSE + NE × 100% Nt where NSE and NE stand for the patients number of the SE and E groups after the treatment, and Nt is the total patients number 2.4 Statistical analysis All the data involved in this study was analyzed using SPSS 15.0 software The enumeration data was presented as number (n) and percentage (%), of which the comparison between the control and observation was made using Chi-square test The measurement data was demonstrated as mean ± SD Comparisons between the measurement data of the control and observation groups was made using t-test P < 0.05 was considered statistically significant Results 2.2 Methods of wound treatment 3.1 The time of wound healing For the patients in the control group, the postoperative wound care was carried out by means of routine sitz cleaning and dressing change [7], until the wound was completely healed For the observation group, the wound was first cleaned by means of routine sitz cleaning and covered with the same dressing as that used in the control group Subsequently, DermFactor® was sprayed on the wound area until it was completely covered by the DermFactor® powder Finally, the wound area was covered with axenic gauze After 24 h, the axenic gauze was removed and the wound area was cleaned and observed for evaluation of the wound healing progress The procedure as mentioned above was repeated until the wound was completely healed The affected areas of the patients were under close observation during the postoperative care [8] Special attention was paid on the surface area, exudate, color and healing time of the wound The total follow up period for all the patients was set to year Symptomatic treatment was carried out in case that untoward reaction took place The wound healing of the patients in the control and observation groups was observed according to previous instruction [9], and the average healing time of the patients was presented in Fig The average healing time of the patients in the observation was 21.86 days, which was significantly shorter than that in the control group (25.36 days, P < 0.05) For the patients suffering from different type of anal disease, the average healing time in the observation group (19.04, 23.72 and 21.14 days for mixed hemorrhoid, anal fistula and fissure in ano, respectively) was also significantly lower than that in the control group (23.25, 27.76 and 24.32 days for mixed hemorrhoid, anal fistula and fissure in ano, respectively) 3.2 Therapeutic effect After 21 days of treatment, the outcome in the control and observation groups was measured and compared with each other, and the 2.3 Outcome measures The criterion for the outcome measures in this study was as the follows: ― The treatment was considered to be “significantly effective” (SE) if the wound was completely cured Table Patients' brief data Patients number (n) Average age (years) Male/Female (n) Control group Observation group 162 43.5 ± 1.9 94/68 168 41.5 ± 2.3 102/66 65 58 39 78 53 37 Type of disease Mixed hemorrhoid (n) Archosyrinx (n) Fissure in ano (n) Fig The wound healing time of the patients in the control and observation (* indicated p < 0.05) 230 International Journal of Surgery 52 (2018) 229–232 S Chen et al Conclusion Table Comparison between the therapeutic effect in the control and observation group after 21 days of treatment Total patients number (n) Control group Observation group 162 168 62 52 48 70.4 74 61 33 80.4 In summary, we found in this study that the postoperative wound healing process of the patients after receiving anal surgery was significantly accelerated by the use of DermFactor®, which did not induce any adverse reaction to the patients Thereafter, the silicate based bioactive dressing DermFactor® seems to be an ideal supplement to the current routine postoperative wound care that would contribute to improved clinical outcome and patients comfort Therapeutic effect OE (patients number, n) E (patients number, n) IMP (patients number, n) INE (patients number, n) Et (%) Ethical approval The study protocol and the patient informed consent was reviewed and approved by the study review board in People's Hospital of Tianjin prior to study initiation results were presented in Table No complication of wound healing occurred in the patients In the control group, the number of the patients that were considered as SE, E, IMP and INE was 62, 52, and 48, respectively In contrast, the observation group has 74, 61, and 33 patients who were consider as SE, E, IMP and INE, respectively The number of SE and E is significantly higher than that in the control group In addition, the observation group showed a higher total effective rate (80.4%) as compared with the control group (70.4%) Author contribution Shuo Chen and Lin Zhang carried out the design, participated all the experiments and finished the data collections Shuo Chen and Zhiguang Huan coordinately analyzed experimental data and prepared the manuscript Jiang Chang proposed the study, reviewed the experimental data and the manuscript and carried out the revision of the manuscript prior to the submission All authors have read and approved the content of the manuscript Discussion Anal diseases, including mixed hemorrhoid, anal fistula and fissure in ano, are common disease all over the world, for which anal surgery is a routine method of treatment However, the wound healing is a major problem in the postoperative care of the anal surgery due to the fact that the anal site is prone to bacterial infection The formation of bacteriotoxin and enzyme induced by the bacterial infection could lead to a series of serious consequence, such as necrosis of local tissue and the dissolution of matrix and collagen fibrils [10], which subsequently result in exacerbated tissue trauma and retarded wound healing In addition, the wound exudation and increased necrotic tissue that are induced by the infected wound could elevate the local strain in the wound, which in turn allows for the diffusion of the infection and hence hinders the wound healing process Due to the unusual condition of the wound site in anal surgery as above mentioned, the postoperative dressing change is crucial for the wound healing, which is one of the most important factors that determine the outcome of the treatment [11] However, the routine treatment may not be adequate for desirable outcome of wound healing In this study, it was clear that DermFactor® possessed the ability of accelerating the wound healing process and improving the therapeutic effectiveness, which was closely related to the well-established physicochemical and biological characteristics of silicate-based wound healing materials Containing silicate micro-particles as the major component, DermFactor® was able to dissolve in a short period once after contacting with the body fluid, when subsequently allowed for the formation of a silica layer on the surface Due to its characteristic surface chemistry, such a silica layer was capable of adsorbing the surrounding biological molecules and hence accelerating the penetration of fibrocytes into the site [12] This process could consequently contribute to the construction of collagen tissue along the surface of the silicate-based micro-particles [13], and then a collagen matrix would be formed in the wound site, which could consequently act as a temporary extracellular matrix that supported the proliferation of fibrocytes, epicytes and endotheliocyte during the regeneration of soft tissue in the wound site [14,15] The overall process enabled the accelerated wound healing by the use of DermFactor® in this study, and the results of this study suggested that DermFactor® is a beneficial wound dressing for the postoperative care after anal surgery Conflicts of interest None Research Registration Unique Identifying Number (UIN) UIN: researchregistry2473 Guarantor Jiang Chang Acknowledgment This study was supported by The National Key Research and Development Program of China (2016YFC1100201) and Shanghai S&T Innovation Action Plan Project (16441904500) References [1] K Ratnasingham, M Uzzaman, S.M Andreani, D Light, B Patel, Meta-analysis of the use of glyceryl trinitrate ointment after haemorrhoidectomy as an analgesic and in promoting wound healing, Int J Surg (2010) 606–611 [2] A.M Salih, Chronic anal fissures: open lateral internal sphincterotomy result; a case series study, Ann Med Surg 15 (2017) 56–58 [3] H.P Moult, M Aubert, V De Parades, Classical treatment of hemorrhoids, J Vis Surg 152 (2015) S3–S9 [4] E.A Carapeti, M.A Kamm, P.J McDonald, R.K Phillips, Double-blind randomised controlled trial of effect of metronidazole on pain after day-case 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DermFactor powder Finally, the wound area was covered... significantly accelerated by the use of DermFactor , which did not induce any adverse reaction to the patients Thereafter, the silicate based bioactive dressing DermFactor seems to be an ideal supplement... process enabled the accelerated wound healing by the use of DermFactor in this study, and the results of this study suggested that DermFactor is a beneficial wound dressing for the postoperative