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WithdrawnNCT03675568Updated Oct 17, 2018

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

An interventional study of Non-cultured keratinocyte suspension and Split skin Graft in Burn Wound, sponsored by Assiut University. Withdrawn. Per ClinicalTrials.gov, last updated 2018-10-17.

Sponsored by Assiut University · Not applicable, Interventional, and Treatment

Why this study was withdrawn
Subject changed
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Sex
All
01

Study summary

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

Read the detailed 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.

02

Conditions studied

  • Burn Wound

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03

In context

Burns

719 studies on the registry are indexed under Burns; 145 are open to participants now.

Browse Burns studies →

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

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

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).
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    study group

    Non-Cultured autologous keratinocyte suspension

    Procedure: Non-cultured keratinocyte suspension

  • Active comparator
    Control group

    Split skin Graft

    Procedure: Split skin Graft

Interventions

  • ProcedureNon-cultured keratinocyte suspension

    A new method for treatment of burn wounds

  • ProcedureSplit skin Graft

    A traditional method for treatment of burn wounds

06

What researchers measure

Primary outcomes

  1. mean Hospital stay

    Number of days patient stays admitted

    Time frame: 1 month

Secondary outcomes

  1. mean healing time

    Number of days until 95% healing

    Time frame: 1 month

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 23598383 ↗
  • 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. PubMed 20038856 ↗
  • 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. doi: 10.1097/00004630-200301000-00006. PubMed 12543987 ↗
  • Deitch EA, Wheelahan TM, Rose MP, Clothier J, Cotter J. Hypertrophic burn scars: analysis of variables. J Trauma. 1983 Oct;23(10):895-8. PubMed 6632013 ↗
  • 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. doi: 10.1016/s0140-6736(83)90392-6. PubMed 6135914 ↗
  • 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. doi: 10.1097/00004630-199807000-00012. PubMed 9710733 ↗
  • Hunyadi J, Farkas B, Bertenyi C, Olah J, Dobozy A. Keratinocyte grafting: a new means of transplantation for full-thickness wounds. J Dermatol Surg Oncol. 1988 Jan;14(1):75-8. doi: 10.1111/j.1524-4725.1988.tb03343.x. PubMed 2447135 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 17, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03675568
Lead sponsor
Assiut University
Responsible party
Sara Diefy Salem (Principal investigator, Assiut University) — Principal investigator
First posted
Sep 18, 2018
Start date
Nov 1, 2018 (estimated)
Primary completion
Sep 30, 2020 (estimated)
Completion
Mar 31, 2021 (estimated)
Last update
Oct 17, 2018

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.

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