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

Comparison Study OF Efficacy Of Autologous Epidermal Cell Suspension And Silver Sulfadiazine Ointment In Second Degree Burn

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.

Study Overview

• Status: Completed
• Conditions: Burn
• Intervention / Treatment: Biological: Autologous epidermal cell suspension; Drug: Silver sulfadiazine ointment

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 2

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Tabriz, Iran, Islamic Republic of
    • Sina Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Autologous epidermal cell suspension group	Biological: Autologous epidermal cell suspension; 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
Active Comparator: Silver sulfadiazine ointment group	Drug: Silver sulfadiazine ointment; the area with second degree burn dresses by silver sulfadiazine ointment and dressing change each 12 hour till 10 day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Scar formation	Observe patient and take photo	After 2 month
Post inflammatory hyperpigmentation	Observe patient and take photo	After 2 month

Collaborators and Investigators

• Sponsor: SCARM Institute, Tabriz, Iran
• Investigators: Study Director: Mohamad Reza Ranjkesh, MD, Dermatologist, SCARM Institute

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2019
• Primary Completion (Actual): March 15, 2020
• Study Completion (Actual): March 15, 2020

Study Registration Dates

• First Submitted: May 18, 2017
• First Submitted That Met QC Criteria: May 19, 2017
• First Posted (Actual): May 22, 2017

Study Record Updates

• Last Update Posted (Actual): March 18, 2020
• Last Update Submitted That Met QC Criteria: March 16, 2020
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: Burn; Epidermal cell suspension
• Additional Relevant MeSH Terms: Wounds and Injuries; Burns; Anti-Infective Agents, Local; Anti-Infective Agents; Anti-Bacterial Agents; Antiprotozoal Agents; Antiparasitic Agents; Coccidiostats; Sulfadiazine; Silver Sulfadiazine
• Other Study ID Numbers: SCARM-Skin-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No