NCT03162367

Brief Summary

Different medical treatments are available for treatment of skin burns such as skin grafts and silver sulfadiazine ointment. These treatments are used for second degree burn as routine technique in burns units. Cell therapy is a new approach for treatment of skin disease.In this study we use autologous epidermal cell suspension to achieve better cosmetic and functional results in treatment of second degree burn.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Apr 2019

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 18, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 22, 2017

Completed
1.9 years until next milestone

Study Start

First participant enrolled

April 10, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2020

Completed
Last Updated

March 18, 2020

Status Verified

June 1, 2019

Enrollment Period

11 months

First QC Date

May 18, 2017

Last Update Submit

March 16, 2020

Conditions

Burn

Keywords

BurnEpidermal cell suspension

Outcome Measures

Primary Outcomes (2)

  • Change in re-epithelization rate with autologous epidermal cell suspension graft from Baseline

    Measurement the percentage of re-epithelization ( 0-30%=poor; 30-60%=moderate; 60-90%=good; \>90%=complete)

    up to 20 days

  • Change in re-epithelization rate with silver sulfadiazine ointment from Baseline

    Measure percentage of re-epithelization ( 0-30%=poor; 30-60%=moderate; 60-90%=good; \>90%=complete)

    up to 20 days

Secondary Outcomes (2)

  • Scar formation

    After 2 month

  • Post inflammatory hyperpigmentation

    After 2 month

Study Arms (2)

Autologous epidermal cell suspension group

EXPERIMENTAL
Biological: Autologous epidermal cell suspension

Silver sulfadiazine ointment group

ACTIVE COMPARATOR
Drug: Silver sulfadiazine ointment

Interventions

Autologous epidermal cell suspensionBIOLOGICAL

First skin samples taken from normal skin by 4mm punch will be send to laboratory for preparation of epidermal cell suspension and this suspension transfer to one area of second degree burn

Autologous epidermal cell suspension group
Silver sulfadiazine ointmentDRUG

the area with second degree burn dresses by silver sulfadiazine ointment and dressing change each 12 hour till 10 day

Silver sulfadiazine ointment group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy patient with second degree burn admitted in burn unit

You may not qualify if:

  • Pregnancy-lactation
  • Immunosuppression like receiving chemotherapy or radiotherapy
  • Patient unsatisfied to going on study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sina hospital

Tabriz, Iran

Location

Related Publications (4)

  • You HJ, Han SK. Cell therapy for wound healing. J Korean Med Sci. 2014 Mar;29(3):311-9. doi: 10.3346/jkms.2014.29.3.311. Epub 2014 Feb 27.

    PMID: 24616577RESULT

  • Zhao H, Chen Y, Zhang C, Fu X. Autologous epidermal cell suspension: A promising treatment for chronic wounds. J Tissue Viability. 2016 Feb;25(1):50-6. doi: 10.1016/j.jtv.2015.11.003. Epub 2015 Dec 8.

    PMID: 26706649RESULT

  • Mcheik JN, Barrault C, Levard G, Morel F, Bernard FX, Lecron JC. Epidermal healing in burns: autologous keratinocyte transplantation as a standard procedure: update and perspective. Plast Reconstr Surg Glob Open. 2014 Oct 7;2(9):e218. doi: 10.1097/GOX.0000000000000176. eCollection 2014 Sep.

    PMID: 25426401RESULT

  • Gardien KL, Marck RE, Bloemen MC, Waaijman T, Gibbs S, Ulrich MM, Middelkoop E; Dutch Outback Study Group1. Outcome of Burns Treated With Autologous Cultured Proliferating Epidermal Cells: A Prospective Randomized Multicenter Intrapatient Comparative Trial. Cell Transplant. 2016;25(3):437-48. doi: 10.3727/096368915X689569. Epub 2015 Sep 28.

    PMID: 26419871RESULT

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • Mohamad Reza Ranjkesh, MD, Dermatologist

    SCARM institute

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 18, 2017

First Posted

May 22, 2017

Study Start

April 10, 2019

Primary Completion

March 15, 2020

Study Completion

March 15, 2020

Last Updated

March 18, 2020

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

Locations

IR(1)