Comparison Between Skin Graft Versus Skin Graft and Stem Cell Application
Condition: Accidental Wound; Heel Injury; Stem Cell Transplant
MeSH terms: Wounds and Injuries
Study type: Interventional
Phase: Phase 1

Summary: 
      Trauma is the leading cause of soft tissue loss of the heel. Children constitute the largest
      group of victims of such injuries. Spoke wheel injury, road traffic accident are common mode
      in the children. Oestern and Tscherne have classified soft tissue injuries into four grades
      from 0-4. The treatment of Grade 0 and 1 injuries is typical cleansing and application of a
      moist wound healing dressing. But further grades need surgical management with debridement
      and reconstruction. Grade III and IV can be reconstructed by using graft, flaps or various
      other techniques. . Skin grafting offers poor functional and cosmetic results, although it is
      commonly performed with good take rates. mesenchymal stem cells will be isolated from
      umbilical cord with informed consent from the mothers. This study will open a new avenue for
      the treatment of heel pad injury. . Since the use of stem cell (especially in Pakistan) is
      completely a new technique in the management of heel pad injury, it will provide insight for
      better management by accelerating the wound healing process.
    

Detailed description: 
      Trauma is the leading cause of soft tissue loss of the heel. Children constitute the largest
      group of victims of such injuries. Spoke wheel injury, road traffic accident are common mode
      in the children. These injuries can range from simple minor abrasions, lacerations to
      crushing of heel. Injury to heel pad and flap has serious impact in day to day life, causing
      disability because it is the major weight bearing area and inherently lacks adequate soft
      tissue.

      Management of injury of heel pad in children depends on severity and extent of soft tissue
      injury. Oestern and Tscherne have classified soft tissue injuries into four grades from 0-4.
      The treatment of Grade 0 and 1 injuries is typical cleansing and application of a moist wound
      healing dressing. But further grades need surgical management with debridement and
      reconstruction.

      Grade III and IV can be reconstructed by using graft, flaps or various other techniques.
      Simple skin graft, lateral rotational skin flap, local muscle flaps, ingenious
      fasciocutaneous island flaps, cross-leg or cross foot flap, free tissue transfer and staged
      or distant jumped flaps are historically included in reconstructive ladder in repairing these
      soft tissue injuries. Generally, free flap reconstruction is the ultimate step of degloving
      wound coverage. Despite availability of various reconstructive techniques, covering of soft
      tissue loss of heel in traumatic events, remains a difficult and demanding procedure,
      especially when it is associated with fractures and complex wounds. Skin grafting offers poor
      functional and cosmetic results, although it is commonly performed with good take rates.

      Stem cells are potential alternative to promote cutaneous wound healing because of its unique
      features like self-renewal and differentiation capacity. Mesenchymal stem cells are type of
      adult stem cells that reside in various tissues of the body. Besides, these cells are
      preferred for cell based therapies because they have immunomodulatory properties. These cells
      can be isolated from bone marrow, adipose tissue and human umbilical cord blood and tissue.
      Recently,umbilical cord derived mesenchymal stem cells have shown a tremendous potential for
      use in tissue engineering and regenerative medicine. Previous studies indicate that these
      mesenchymal stem cells can accelerate wound healing by enhanced proliferation and migration
      of human fibroblast, enhancing secretion of elastin, synthesizing collagen, angiogenesis and
      further maturing blood vessels present in wound site. Stem cell-based therapies will
      definitely be the major part of clinical medicine in next decade.

      In the current study, mesenchymal stem cells will be isolated from umbilical cord with
      informed consent from the mothers. This study will open a new avenue for the treatment of
      heel pad injury. Considering the role of stem cells in wound healing, study has been designed
      to accelerate the wound healing process in children with heel pad injury. Since the use of
      stem cell (especially in Pakistan) is completely a new technique in the management of heel
      pad injury, it will provide insight for better management by accelerating the wound healing
      process, reducing the hospital stay and cost of treatment. Rationale of our study aims to
      compare outcome of heel pad injury managed with skin graft with infiltration of mesenchymal
      stem cell Versus management with skin graft only.
    

Intervention name(s): mesenchymal stem cell application
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Cases were divided into two groups. Group A included cases with skin graft only and group B included cases with skin graft and application of mesenchymal stem cells. Every odd patients were kept in group A and every Even patients were kept in group B.
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: spoke wheel injury; umbilical cord mesenchymal stem cells; skin grafting