The Evaluation Of The Clinical Effect Of The New-Developed Domestic Artificial Dermis

Backgroud With the economic progress of our society and the improvement of people's living standard,the rescue of burn patients is not content to save lives,but rather to increase the standards of living and protect the patient's appearance and function maximum.Since the first international synthetic dermal substitution Integra was approved applied in 1996,much research demonstrated that Integra combined with autologous thin skin grafts can make good clinical effect.Not only the skin transplantation area can obtain wear-resisting covering,but also the healing time of the donor site was shortened without hyperplastic scar,which can solved the limitations of traditional operation method to a certain extent.But the Pelnac imported from Japan is the only synthetic dermal substitution in China,but result from the stiff price,this method is promoted very slowly.Part one: The evaluation of safety and clinical efficacy of the new-developed domestic artificial dermis combined with autologous split-thickness skin for treatment of full-thickness skin defect woundsObjective The evaluation of the safety and clinical efficacy of the new domestic artificial dermis for the cure full-thickness skin defect wounds.Methods From April 2014 to September 2015,142 patients with full-thickness skin defect included in this study from six burn center.Patients were randomly assigned to Lando treatment group and Plenac treatment group according to the admission time,the Lando group were treated with domestic artificial dermis(Lando,shenzhen kang qi medical instrument co.,LTD.)combined with autologous split-thickness skin,the Plenac group were treated with PELNAC(enhanced,Japan Gunze Limed,LSD)combined with autologous split-thickness skin.Evaluation indicators included :1?security indicators: blood routine examination?liver function examination(glutamic-pyruvic transaminase and glutamic-oxalacetic transaminase)?kidney function(blood urea nitrogen,serum creatinine)and serum immunoglobulin examination(Ig M and Ig G),which were examined before the implantation of artificial dermis surgery,1 month postoperative and 3 months postoperative respectively.2?effectiveness indicators: the take of skin graft(10 days postoperation)? scar assessment using the Vancouver Scar Score and pain assessment(1 and 3 months after skin transplantation operation).Results Security indicators: the blood testing indicators before operative had no statistical significance between the Lando group and Pelnac group(P > 0.05),the difference value of the blood indicators of one month postoperation and preoperation between the Lando group and Pelnac group had no significant variation(P > 0.05),but the difference of white blood cell between Lando group and Pelnac group had significant variation(P < 0.05).The difference value of the blood indicators between three month after operative and preoperation had no statistical significance difference(P > 0.05).Effectiveness indicators: the survival rate of skin graft had no statistically significant variation between Lando group and Pelnac group(P > 0.05),the scar scores in 1 month after implantation of artificial dermis between Lando group and Pelnac group had no significant variation(P > 0.05),the scores of the colour and lustre and softness of scar in three month after skin grafting between Lando group and Pelnac group had no significant variation(P > 0.05),but the hyperemia color and thickness of scar was better in Lando group than that in Pelanc group(P < 0.05);the pain in 1 and 3 month postoperatiin had no significant variation between Lando group and Pelnac group(P > 0.05).Conclusions The new domestic artificial dermis combined with autologous split-thickness skin transplantation can obtain satisfactory cover,whose safety is reliable,it is superior to Pelnac in inhibiting scar formation.Part two:The evaluation of the effect of the new-developed domestic artificial dermis combined with autologous split-thickness skin for treatment of wounds with bone or tendon exposureObjective Exploring the clinical curative effect of the new-developed domestic artificial dermis for treatment of wounds with bone or tendon exposure.Methods This article retrospective analysed 22 patients with born or tendon exposed wounds in the Lando clinical trials from April 2014 to September 2015,observation group of 13 patients using Lando combined with autologous split-thickness skin,control group using Pelnac combined autologous split-thickness skin to repair wounds.Statistics data involved times of implantation of the artificial dermis,interval between first implantation of artificial dermis and skin grafting,the take of skin graft 10 days after skin grafting,whether there had burst in the 3 months follow-up and scar assessment using the Vancouver Scar Score.Results The implantation times of Lando treatment group was 1 time of 9 cases,2 times of 4 cases,the Pelnac treatment group was 1 time of 7 cases,2 times of 2 cases,without significant variation between them(?2 = 0.20,P>0.05);the survival rate of skin graft and the score of scar assessment of the observation group was(96.15±5.46)%, (4.08±1.85)days respectively,and the control group was(95.00±5.60)%,(5.56±1.33)days,with no significant difference between them(t =0.48,2.05,p>0.05);the spacing interval of lando group was(19.23±6.80)days,the pelnac group was(14.67±5.00)days,with significant variation(t = 2.11,p < 0.05);all the Lando treatment group and Pelanc treatment group had 1 patient with burst in the 3 months follow-up,without significant variation(?2 = 0.08,P>0.05).Conclusions Lando can accomplish satisfactory vascularization on the wounds with bone or tendon exposure,and achieve stable wound coverage combined with thin layer skin graft,its curative effect has no statistically significant with Pelnac.