Skip to main content
OpenTrials
Completed

NCT Number: NCT00832156

Application of Cultured Autologous Keratinocytes for Burn Wound Healing

In this study the treatment of full thickness burn wounds with cultured autologous keratinocytes in combination with meshed split skin autograft versus meshed split skin graft alone will be compared. It is expected that the application of cultured autologous keratinocytes in combination with a meshed split skin autograft will improve wound healing and scar formation.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Red Cross Hospital

Beverwijk, North Holland, 1942 LE, Netherlands

About this study

The standard treatment for extensive burn wounds is transplantation with meshed split skin graft. Disadvantages of this treatment are that healing of large full thickness burn wounds is still accompanied by scar formation. Even standard treatment, transplantation with a (meshed) split skin autograft, does not result in satisfactory functional and cosmetic appearance of the healed wound. Due to limited available donor sites meshes needs to be enlarged. Bigger enlargements of meshes give more scarring and mesh pattern are still visible in scars, probably because wound closure still needs several weeks. Application of cultured autologous keratinocytes may enhance wound closure and improve outcome of healing.

Primary objective: Does the application of cultured autologous keratinocytes on deep burn wounds accelerate wound closure Secondary objectives: Does the application of cultured autologous keratinocytes on deep burn wounds improve scar quality with respect to scar elasticity, colour/pigmentation and/or smoothness after 3 and 12 months.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Competent and temporarily incompetent patients 18 years of age or older with acute burn wounds that require widely meshed skin grafting, which do not need immediate excision
  • Minimal study wound area 100 cm2
  • Maximal study wound area 300 cm2
  • Maximal TBSA 30% full thickness wounds
  • Informed consent

Exclusion criteria

  • Immunocompromised patients
  • Infected wounds
  • Use of high doses of (.20mg/pd) corticosteroids and/or cytostatica
  • Known penicillin allergy
  • Conditions where the patient is non compliant as judged by a medical specialist

Treatment and study plan

Cultured autologous keratinocytes

Biological

The experimental wound site will be covered with cultured keratinocytes on a collagen/elastin carrier after the application of a meshed split skin autograft. The control wound site will be covered with a meshed split skin autograft alone.

Other names: Cultured keratinocytes

Primary outcomes

  1. Primary end point is the percentage of wound closure.

    Time frame: 7 days

Secondary outcomes

  1. Secondary objective is scar quality (i.e. subjective scar assessment, scar elasticity, colour and pigmentation of the scar and smoothness of the scar surface).

    Time frame: 3 and 12 months

Sponsors and collaborators

Lead sponsor

Association of Dutch Burn Centres

Other

Registry information

Official study title

Application of Cultured Autologous Keratinocytes in Combination With a Meshed Split Skin Autograft for Burn Wound Healing

Acronym: KC

Important dates

Study start
2008
Primary completion
2012
Study completion
2013
First posted
Jan 29, 2009
Registry last updated
Feb 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.