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

Burn Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03162367
• Other study ID #: SCARM-Skin-002
• Status: Completed
• Phase: Phase 2
• Start date: April 10, 2019
• Est. completion date: March 15, 2020

Study information

• Verified date: June 2019
• Source: SCARM Institute, Tabriz, Iran
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 15, 2020
• Est. primary completion date: March 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Burn
• Burns

Intervention

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

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

Locations

Country	Name	City	State
Iran, Islamic Republic of	Sina hospital	Tabriz

Sponsors (1)

Lead Sponsor	Collaborator
SCARM Institute, Tabriz, Iran

Country where clinical trial is conducted

Iran, Islamic Republic of, 

References & Publications (4)

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 Tria — View 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.000 — View 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. Review. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Scar formation	Observe patient and take photo	After 2 month
Secondary	Post inflammatory hyperpigmentation	Observe patient and take photo	After 2 month