Comparison Between Skin Graft Versus Skin Graft and Stem Cell Application

NCT ID: NCT04219657

Last Updated: 2020-02-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-29
• Study Completion Date: 2019-12-22

Brief 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.

Conditions

Accidental Wound; Heel Injury; Stem Cell Transplant

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

skin grafting only

All the cases in this group are managed with skin grafting only. Every odd case are kept in skin grafting only group.

Group Type: EXPERIMENTAL

mesenchymal stem cell application

Intervention Type: BIOLOGICAL

skin grafting and stem cell group

All the cases in this group are managed with skin grafting and application of stem cells. every even cases are kept in skin grafting and stem cells group.

Group Type: EXPERIMENTAL

mesenchymal stem cell application

Intervention Type: BIOLOGICAL

Interventions

mesenchymal stem cell application

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Pediatric age group population (less than 12 years) irrespective of sex.
• Children with traumatic heel pad injury requiring skin grafting admitted through outdoor and emergency department.

Exclusion Criteria

• Children with traumatic heel pad injury associate with other systemic injury requiring surgical/medical treatment other than skin graft/flap.
• Traumatic heel pad injury with calcaneal fracture.
• Children with traumatic heel pad injury with osteomyelitis, Idiopathic thrombocytopenic purpura, diabetes mellitus and immunodeficiency state under medication.

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

King Edward Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

FATIMA NAUMERI, assoc Prof

Role: STUDY_DIRECTOR

King Edward Medical University

Locations

Pediatric Surgery Department, King Edward Medical University

Lahore, Punjab Province, Pakistan

Countries

Pakistan

References

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Other Identifiers

Sushil_Rijal

Identifier Type: -

Identifier Source: org_study_id