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The effects of fetal fibroblast in skin wound healing

The effects of Acellular Amniotic membrane loaded by cultured fetal fibroblast cells in split thickness skin wound healing

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT201302218177N6
Enrollment
10
Registered
2013-06-29
Start date
2013-06-22
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Skin Wound. Open wound of unspecified body region

Interventions

Intervention 1: Intervention 1: Coverage of the skin graft donor site with acellular amnion loaded with cultured fetal fibroblast cell. The dressing will be changed every other day till complete heali
Treatment - Other
Intervention 1: Coverage of the skin graft donor site with acellular amnion loaded with cultured fetal fibroblast cell. The dressing will be changed every other day till complete healing of the wound
Intervention 2: Coverage of the skin graft donor site with acellular amnion. The dressing will be changed every other day till complete healing of the wound after 3 days.
Control group: Coverage of the skin graft donor site with Vaseline gauze. The dressing will be changed every other day till complete healing of the wound after 3 days.

Sponsors

Vice chancellor for research of Tehran University of Medical
Lead Sponsor

Eligibility

Sex/Gender
All
Age
8 Years to 60 Years

Inclusion criteria

Inclusion criteria: Laboratory inclusion criteria: 1. Pregnant women who are older than 18 years old that had to be aborted 2. Filling informed consent 3. Aborted fetus with the age of 11 to 14 weeks 4.Lack of infectious diseases (HIV-HBV-HCV) 5.Lack consumption of immune-suppressive and cytotoxic drugs during past 6 months Laboratory exclusion criteria: 1. Aborted fetus that is younger than 11 weeks or older than 14 weeks 2.Pregnant women who are younger than 18 years old Clinical inclusion criteria: 1.Patients with the age of 20 to 60 years old 2. Those who need skin graft surgery 3.The extent of surgical site wound 10-30% 4. Filling informed consent 5. Lack of co-morbidity Clinical exclusion criteria: 1.Under the age of 20 years and above 60 years 2.The extent of surgical site wound more than 30% and less than 10% 3.Lack of informed consent

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Wound healing. Timepoint: Examination and photography on 3, 5, 7, 11, 13 and 15 days and 1 month after surgery - biopsy on 7 day? after surgery. Method of measurement: Observation and Examination and Biopsy.

Secondary

MeasureTime frame
Pain. Timepoint: Three, five, seven, nine, eleven, thirteen and fifteen days after surgery. Method of measurement: Visual Analogue Scale.;Infection. Timepoint: Seven and fifteen days after surgery. Method of measurement: Examination, Wound Culture.;Scar. Timepoint: Three and six months after surgery. Method of measurement: Vancouver Scar Scale.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohammad Javad Fatemi

Hazrat Fatima hospital

mj-fatemi@sina.tums.ac.ir+98 21 8871 7272

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026