跳至主要内容
临床试验/CTRI/2024/04/065325
CTRI/2024/04/065325尚未招募不适用

Usage Of Dermal Template for Reconstruction of Complex defects - a prospective observational study

Kasturba medical college1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2024年4月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
80
试验地点
1
主要终点
Rate of wound healing by area of defect covered after dermal template

研究概览

简要总结

When facing wound reconstruction, trauma and plastic surgeons have different options

to choose from, including skin grafting, local, regional, distant pedicled and free flaps,

and tissue expansion(1). Yet, Skin and soft tissue reconstruction remains a challenge

for plastic surgeons because of optimal aesthetic and functional outcomes.

For many centuries, skin grafts have been used to restore wound defects after trauma,

vascular disease, or cancer. However, availability of sufficient healthy skin can be an

issue, as well as the additional health risks associated with the procedure. The

deforming donor-site morbidity should also be considered when opting for skin grafting.

Disadvantages as such have led to innovations in skin tissue engineering.

Dermal template offers multiple advantages: It prepares the wound before the

positioning of a split-thickness skin graft. It is applicable in anatomical regions in which a

graft placement alone would not be preferred, such as on bone and tendon-exposed

areas, and improves the final outcome and feature of the scar. The positioning of the

matrix is relatively simple with a reduction of operating time. It allows the reduction of

inpatient time in the hospital and of surgical sequelae for the patient. However, Dermal

Templates could also be susceptible to infection, need a second procedure for the

coverage of the matrix with a skin graft, and have a relatively high cost compared to

autografts. Dermal templates are playing an increasingly important role in reconstruction

of complex defects, however there is a lack of evidence on their long-term outcomes. In

India, there is a lack of comprehensive studies detailing use and outcomes of dermal

templates .We aimed to review the use, outcomes and complications of IDRT within our

tertiary care centre, KMC, Manipal.

研究设计

研究类型
Observational

入排标准

年龄范围
10.00 Day(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • All patients with complex defects, of any age group scheduled for plastic reconstruction.
  • Patient willing to follow protocol and giving positive consent.
  • Patient profile includes: a.
  • Complex wounds which are non-graftable following serial dressings and thorough surgical debridement.
  • Patients in whom multiple procedures were already done for trauma or where the potential recipient vessels come within the trauma zone and not feasible for free flap.
  • Patients in whom flap failure has occurred and simple methods of local tissue transfer are not feasible.
  • Non infective wounds confirmed by gram staining and negative culture.
  • Areas where chances of post-operative scarring and /or contractures are greater, owing to location, nature and etiology of injury.

排除标准

  • Exclusion criteriai.
  • Patients whose defect does not fit the criteria for dermal template ii.
  • Patients not giving positive consent or not following protocol iii.
  • Patients who are lost for follow up and who developed systemic infections will be secondarily excluded.
  • Deranged liver, kidney, lung, cardiac functions v.
  • Patients in whom waiting for 3 weeks before grafting is not feasible in case of IDRT®and waiting for a minimum of 5 days not feasible in case of Matriderm® .

结局指标

主要结局

Rate of wound healing by area of defect covered after dermal template

时间窗: 1 year

reconstruction.

时间窗: 1 year

次要结局

  • Proportion of patients with IDRT failure.(ii. Proportion of patients needing other tissue transfer like flap in case of DRT failure)

研究者

申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Neha Mookim

KMC, MANIPAL

研究点 (1)

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