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Amniotic membrane extract drops in wound healing of semi-thickness skin donor site

The effect of amniotic membrane extract drops in wound healing of semi-thickness skin donor site in human models

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT201703148177N16
Enrollment
46
Registered
2017-04-03
Start date
2017-05-05
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

Wound. Open wound of unspecified body region

Interventions

Intervention 1: Intervention group: Wound covering of donor site of skin transplantation with amniotic membrane extract drops. From the day of surgery, dressing is changed every 3 days until complete
Treatment - Drugs
Intervention group: Wound covering of donor site of skin transplantation with amniotic membrane extract drops. From the day of surgery, dressing is changed every 3 days until complete wound healing
Control group: Wound covering of donor site of skin transplantation with solvent amniotic membrane extract drops (normal saline). From the day of surgery, dressing is changed every 3 days until comple

Sponsors

Iran University of Medical Sciences
Lead Sponsor
Added at 2017-08-20: Royan Institute for Stem Cell Biology and Technology (RI-SCBT
Collaborator

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: age 18-65 years old; requiring skin graft surgery; signing informed consent. Exclusion criteria: removal of skin graft from the outside of the thigh; conditions and diseases in which the immune system is weakened and wound healing is delayed such as: diabetes, cancer, immune system dysfunction, drugs that suppress the immune system, taking corticosteroids, smoking and alcohol; patients who do not cooperate with treatment and referrals necessary after surgery.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Wound Healing. Timepoint: Observation, examination and photography on days 1 and 12 after surgery and during spontaneous separation of Vaseline gauze from wound. Method of measurement: Observation, examination and photography.

Secondary

MeasureTime frame
Cost. Timepoint: The end of the study. Method of measurement: Cost estimation of the number of drops used in each treatment group.;Scar. Timepoint: 6 months after surgery. Method of measurement: Vancouver Scar Scale, Patient and Observer Scar Assessment Scale (POSAS).;Infection. Timepoint: Every 3 days after surgery until complete wound healing. Method of measurement: Observation, examination and wound culture.;Pain. Timepoint: 3, 6 and 12 days after surgery. Method of measurement: Visual Analogue Scale (VAS).

Countries

Iran (Islamic Republic of)

Contacts

Public ContactTooran Bagheri

Burn Research Center

tooran_bagheri@yahoo.com+98 21 8888 4275

Outcome results

None listed

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