Non-cultured Autologous Keratinocyte Suspension Versus Traditional Split Skin Graft for Burn Wounds Treatment

Burn Wound Clinical Trial

Official title:

Non-cultured Autologous Keratinocyte Suspension for Treatment of Deep Dermal Burn and Post-Burn Raw Area Versus Traditional Split Skin Graft

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03675568
• Other study ID #: NCAKS
• Status: Withdrawn
• Phase: N/A
• Start date: November 1, 2018
• Est. completion date: March 31, 2021

Study information

• Verified date: October 2018
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A study comparing effect of non-cultured autologous keratinocyte suspension on burn wounds treatment compared with traditional split skin graft

Description:

Burn injuries are complicated wounds to manage with a relative high mortality rate in especially large area burns and elderly patients.

Substantial tissue damage and extensive fluid loss can cause impaired vital functions of the skin. When healing is delayed, the potential short term common complications include wound infection affecting the local healing process or systemic inflammatory and immunological responses which subsequently can cause life threatening sepsis and multi-organ failure.

Fortunately, survival rates have improved drastically over the last century due to advancements in burn care such as early surgical intervention, critical care support and wound care.

For many years the "gold standard" for treating wounds of burn patients has been transplantation with an autologous split skin graft. In patients with extensive burn wounds donor sites may be limited. In order to cover all the wounds, the patients often need multiple operations and/or the skin had to be expanded as much as possible.

However, the current different expansion techniques and treatments [mesh and Meek-Wall] frequently lead to scar formation, especially in the large mesh inter-sites.

The rate of wound closure depends on how quickly epidermal cells migrate out of the meshed auto graft and/ or wound edges to close the wound. Accelerating re-epithelialization could potentially improve the outcome of the healing process in terms of reducing granulation tissue formation, reducing the healing time, and thereby reducing the risk of colonization and infection, as well as scar formation.

Since clinical cases were first successfully treated with cultured epithelial layers, keratinocyte sheets have become an important tool in burn wound treatment. However, the clinical application can be limited by long culture time and fragility of the keratinocyte sheets. There is, therefore, a clinical demand for other options to cover large areas of burn wounds in the absence of viable donor sites.

A novel concept consists of treating wounds with epithelial cell suspensions. In 1998, Fraulin et al. developed a method of spreading cell suspension on to wounds using an aerosol spray in a porcine model.

The use of non-cultured keratinocyte suspensions was first reported by Hunyadi et al., showing that a group of patients with burn wounds or chronic leg ulcers, treated with a fibrin matrix containing keratinocytes, healed completely, as opposed to the control group.

In porcine wound models, non-cultured keratinocyte suspensions have been shown to accelerate wound healing, improve quality of epithelialization, and restore melanocyte population, compared to the respective control group.

Major advantages in the use of non-cultured cell suspensions are a drastic reduction of preparation time and possibly easier handling compared to keratinocyte sheets. Particularly, scar quality may be improved by enhancing the speed of epithelialization and fading of mesh patterns in split skin grafts.

In this study, we will compare the results of treating both deep dermal burn wound -following early excision- and post-burn raw area using non-cultured autologous keratinocyte suspension and traditional split skin graft.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 31, 2021
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Deep dermal burns more than 10% total body surface area which require surgical debridement and epidermal replacement.

• Post-burn raw area more than 10% total body surface area

Exclusion Criteria:

• Presence of pre-existing local and systemic bacterial infections.

• Pre-existing medical conditions that would interfere with wound healing (uncontrolled diabetes mellitus, malignancy, congestive heart failure, autoimmune disease, renal failure, corticosteroids and immunosuppressive drugs).

Related Conditions & MeSH terms

• Burn Wound
• Burns

Intervention

Procedure:
• Non-cultured keratinocyte suspension
A new method for treatment of burn wounds
• Split skin Graft
A traditional method for treatment of burn wounds

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (7)

Deitch EA, Wheelahan TM, Rose MP, Clothier J, Cotter J. Hypertrophic burn scars: analysis of variables. J Trauma. 1983 Oct;23(10):895-8. — View Citation

Fraulin FO, Bahoric A, Harrop AR, Hiruki T, Clarke HM. Autotransplantation of epithelial cells in the pig via an aerosol vehicle. J Burn Care Rehabil. 1998 Jul-Aug;19(4):337-45. — View Citation

Hefton JM, Madden MR, Finkelstein JL, Shires GT. Grafting of burn patients with allografts of cultured epidermal cells. Lancet. 1983 Aug 20;2(8347):428-30. — View Citation

Hunyadi J, Farkas B, Bertényi C, Oláh J, Dobozy A. Keratinocyte grafting: a new means of transplantation for full-thickness wounds. J Dermatol Surg Oncol. 1988 Jan;14(1):75-8. — View Citation

Jackson PC, Hardwicke J, Bamford A, Nightingale P, Wilson Y, Papini R, Moiemen N. Revised estimates of mortality from the Birmingham Burn Centre, 2001-2010: a continuing analysis over 65 years. Ann Surg. 2014 May;259(5):979-84. doi: 10.1097/SLA.0b013e31829160ca. — View Citation

McGwin G Jr, Cross JM, Ford JW, Rue LW 3rd. Long-term trends in mortality according to age among adult burn patients. J Burn Care Rehabil. 2003 Jan-Feb;24(1):21-5. — View Citation

Osler T, Glance LG, Hosmer DW. Simplified estimates of the probability of death after burn injuries: extending and updating the baux score. J Trauma. 2010 Mar;68(3):690-7. doi: 10.1097/TA.0b013e3181c453b3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mean Hospital stay	Number of days patient stays admitted	1 month
Secondary	mean healing time	Number of days until 95% healing	1 month