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

Phase 2

Completed

• Conditions: Burn
• Interventions: Drug: Silver sulfadiazine ointment; Biological: Autologous epidermal cell suspension

• Registration Number: NCT03162367
• Lead Sponsor: SCARM Institute, Tabriz, Iran

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.

Study Timeline

• Study First Submitted: 2017-05-18
• Study First Submitted QC: 2017-05-19
• Study First Posted: 2017-05-22
• Study Start: 2019-04-10
• Status Verified: 2019-06
• Primary Completion: 2020-03-15
• Study Completion: 2020-03-15
• Last Update Submitted: 2020-03-16
• Last Update Posted: 2020-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Silver sulfadiazine ointment group	Silver sulfadiazine ointment	-
Autologous epidermal cell suspension group	Autologous epidermal cell suspension	-

Primary Outcome Measures

Name	Time	Method
Change in re-epithelization rate with autologous epidermal cell suspension graft from Baseline	up to 20 days	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	up to 20 days	Measure percentage of re-epithelization ( 0-30%=poor; 30-60%=moderate; 60-90%=good; \>90%=complete)

Secondary Outcome Measures

Name	Time	Method
Scar formation	After 2 month	Observe patient and take photo
Post inflammatory hyperpigmentation	After 2 month	Observe patient and take photo

Trial Locations

Locations (1)

Sina hospital; 🇮🇷 Tabriz, Iran, Islamic Republic of