Amniotic Membrane Effect in Aplasia Cutis

Treating aplasia cutis with amniotic membrane in newborn Infants

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT20191024045229N1

Enrollment

Registered

2019-12-28

Start date

2019-12-21

Completion date

Unknown

Last updated

2020-01-13

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

Conditions

Aplasia Cutis Congenita. Other specified congenital malformations of skin

Interventions

Intervention group: Amniotic Membrane dressing (Sinacell Co.) as Allograft every 7 days, dressing size selection based on wound dimensions, until epithelization.

Eligibility

Sex/Gender

All

Age

1 Days to 90 Days

Inclusion criteria

Inclusion criteria: Newborn Infants suffered from Aplasia Cutis Congenita

Exclusion criteria

Exclusion criteria: Presence of Life Threatening Anomaly Suffering from Dystrophic Epidermolisis Bulosa Aplasia Cutis Congenita less than 1 centimeter

Design outcomes

Primary

Measure	Time frame
Epithelization. Timepoint: Before intervention and weekly until complete skin formation. Method of measurement: Clinical Assessment.	—

Secondary

Measure	Time frame
Death. Timepoint: During the Study. Method of measurement: Electrocardiography.;Sepsis. Timepoint: Baseline (before the intervention) and weekly. Method of measurement: Blood Test and Clinical prove.;Hospitalization Period. Timepoint: During the Study. Method of measurement: Documents Assessment.;Electrolytes Abnormality. Timepoint: Baseline (before the intervention) and weekly if necessary. Method of measurement: Blood Test.;Systemic Antibiotic Therapy. Timepoint: Baseline (before the intervention) and weekly if necessary. Method of measurement: Prescription duration.;Scar Forming after Wound Treatment. Timepoint: After Wound Healing. Method of measurement: 'Vancouver Scare Scale' questionnaire.;Wound Erythema. Timepoint: Baseline (before the intervention) and weekly. Method of measurement: Clinical Assessment.;Wound Infection. Timepoint: Baseline (before the intervention) and weekly if necessary. Method of measurement: Wound Exuda Culturing.;Frequency of Amniotic membrane changing. Timepoint: During the Study. Method of measurement: Document Assessment.;Time to Epithelization. Timepoint: Baseline (before the intervention) and weekly. Method of measurement: Logging the epithelization time via clinical assessment.	—

Measure

Time frame

Death. Timepoint: During the Study. Method of measurement: Electrocardiography.;Sepsis. Timepoint: Baseline (before the intervention) and weekly. Method of measurement: Blood Test and Clinical prove.;Hospitalization Period. Timepoint: During the Study. Method of measurement: Documents Assessment.;Electrolytes Abnormality. Timepoint: Baseline (before the intervention) and weekly if necessary. Method of measurement: Blood Test.;Systemic Antibiotic Therapy. Timepoint: Baseline (before the intervention) and weekly if necessary. Method of measurement: Prescription duration.;Scar Forming after Wound Treatment. Timepoint: After Wound Healing. Method of measurement: 'Vancouver Scare Scale' questionnaire.;Wound Erythema. Timepoint: Baseline (before the intervention) and weekly. Method of measurement: Clinical Assessment.;Wound Infection. Timepoint: Baseline (before the intervention) and weekly if necessary. Method of measurement: Wound Exuda Culturing.;Frequency of Amniotic membrane changing. Timepoint: During the Study. Method of measurement: Document Assessment.;Time to Epithelization. Timepoint: Baseline (before the intervention) and weekly. Method of measurement: Logging the epithelization time via clinical assessment.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMalihe Kadivar

Tehran University of Medical Sciences

Kadivarm@tums.ac.ir+98 21 6147 9000

Outcome results

None listed

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