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Efficacy Of Autologous Epidermal Cell Suspension And Silver Sulfadiazine Ointment In Burn

Primary Purpose

Burn

Status
Completed
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Autologous epidermal cell suspension
Silver sulfadiazine ointment
Sponsored by
SCARM Institute, Tabriz, Iran
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Burn focused on measuring Burn, Epidermal cell suspension

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Healthy patient with second degree burn admitted in burn unit

Exclusion Criteria:

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

Sites / Locations

  • Sina hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Autologous epidermal cell suspension group

Silver sulfadiazine ointment group

Arm Description

Outcomes

Primary Outcome Measures

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)
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)

Secondary Outcome Measures

Scar formation
Observe patient and take photo
Post inflammatory hyperpigmentation
Observe patient and take photo

Full Information

First Posted
May 18, 2017
Last Updated
March 16, 2020
Sponsor
SCARM Institute, Tabriz, Iran
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1. Study Identification

Unique Protocol Identification Number
NCT03162367
Brief Title
Efficacy Of Autologous Epidermal Cell Suspension And Silver Sulfadiazine Ointment In Burn
Official Title
Comparison Study OF Efficacy Of Autologous Epidermal Cell Suspension And Silver Sulfadiazine Ointment In Second Degree Burn
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
April 10, 2019 (Actual)
Primary Completion Date
March 15, 2020 (Actual)
Study Completion Date
March 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SCARM Institute, Tabriz, Iran

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
In this study 20 patients in Burn Department of Sina Hospital Tabriz, with at least 2 areas of second degree burn randomly choose. First skin samples are taken from normal skin by 4mm punch and send to the laboratory for preparation of epidermal cell suspension and this suspension is transferred to the one area of second degree burn in each patient and the other area in the same patient dresses by silver sulfadiazine ointment. The dressing changes are followed up for 12h for first assessment of therapy until 10th day after intervention. In the days of 5, 10, 15 and 20 the percentage of re-epithelization for each treatment will be measured. After 2 months, patients are visited and any complications check for scar formation, pain, post inflammatory hyper-pigmentation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burn
Keywords
Burn, Epidermal cell suspension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Non-Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Autologous epidermal cell suspension group
Arm Type
Experimental
Arm Title
Silver sulfadiazine ointment group
Arm Type
Active Comparator
Intervention Type
Biological
Intervention Name(s)
Autologous epidermal cell suspension
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Silver sulfadiazine ointment
Intervention Description
the area with second degree burn dresses by silver sulfadiazine ointment and dressing change each 12 hour till 10 day
Primary Outcome Measure Information:
Title
Change in re-epithelization rate with autologous epidermal cell suspension graft from Baseline
Description
Measurement the percentage of re-epithelization ( 0-30%=poor; 30-60%=moderate; 60-90%=good; >90%=complete)
Time Frame
up to 20 days
Title
Change in re-epithelization rate with silver sulfadiazine ointment from Baseline
Description
Measure percentage of re-epithelization ( 0-30%=poor; 30-60%=moderate; 60-90%=good; >90%=complete)
Time Frame
up to 20 days
Secondary Outcome Measure Information:
Title
Scar formation
Description
Observe patient and take photo
Time Frame
After 2 month
Title
Post inflammatory hyperpigmentation
Description
Observe patient and take photo
Time Frame
After 2 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Healthy patient with second degree burn admitted in burn unit Exclusion Criteria: Pregnancy-lactation Immunosuppression like receiving chemotherapy or radiotherapy Patient unsatisfied to going on study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamad Reza Ranjkesh, MD, Dermatologist
Organizational Affiliation
SCARM institute
Official's Role
Study Director
Facility Information:
Facility Name
Sina hospital
City
Tabriz
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24616577
Citation
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.
Results Reference
result
PubMed Identifier
26706649
Citation
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.
Results Reference
result
PubMed Identifier
25426401
Citation
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.
Results Reference
result
PubMed Identifier
26419871
Citation
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.
Results Reference
result

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Efficacy Of Autologous Epidermal Cell Suspension And Silver Sulfadiazine Ointment In Burn

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