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

NCT03675568 | Withdrawn

• 1 other identifier: NCAKS
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Burn Wound

Outcome Measures

Primary Outcomes (1)

• mean Hospital stay

  Number of days patient stays admitted

  1 month

Secondary Outcomes (1)

• mean healing time

  1 month

Study Arms (2)

study group

EXPERIMENTAL

Non-Cultured autologous keratinocyte suspension

Procedure: Non-cultured keratinocyte suspension

Control group

ACTIVE COMPARATOR

Split skin Graft

Procedure: Split skin Graft

Interventions

Non-cultured keratinocyte suspension PROCEDURE

A new method for treatment of burn wounds

study group

Split skin Graft PROCEDURE

A traditional method for treatment of burn wounds

Control group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Assiut University: lead

Related Publications (7)

• 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.

  PMID: 23598383 BACKGROUND

• 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.

  PMID: 20038856 BACKGROUND

• 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.

  PMID: 12543987 BACKGROUND

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

  PMID: 6632013 BACKGROUND

• 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.

  PMID: 6135914 BACKGROUND

• 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.

  PMID: 9710733 BACKGROUND

• 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.

  PMID: 2447135 BACKGROUND

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: September 17, 2018
• First Posted: September 18, 2018
• Study Start: November 1, 2018
• Primary Completion: September 30, 2020
• Study Completion: March 31, 2021
• Last Updated: October 17, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share