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Evaluation of the effect of artificial dermal scaffolds as a covering for autologous micro-skin grafts in the treatment of large area hypertrophic scars

Evaluation of the effect of artificial dermal scaffolds as a covering for autologous micro-skin grafts in the treatment of large area hypertrophic scars

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900024101
Enrollment
Unknown
Registered
2019-06-25
Start date
2019-07-01
Completion date
Unknown
Last updated
2019-07-01

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

Conditions

scar

Interventions

Group 1:The surface of the microscopic skin is underneath, and the artificial dermal support is placed on the wound surface after the scar is removed.
Group 2:The artificial dermal stent was sutured on the wound surface after the scar resection, and the autologous ultrathin skin graft was performed 21 days later.

Sponsors

Shanghai Changhai Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 60 Years

Inclusion criteria

Inclusion criteria: (1) Aged 0 to 60 years, male or female; (2) The clinical diagnosis is hypertrophic scar after burn. The burn area is: 0-6 years old >=5%, 6-18 years old >=10%, adult >=15%, and the proliferative time is June~1 year; (3) The total area of a single scar to be removed at one time is <2% (estimated by the palm method), and the target wound after the scar is expected to be between 5 cm x5 cm and 10 cm x10 cm, and the position of the scar is the limbs or the trunk; (4) Confirmed by the clinician, using other methods to treat poor results or seriously affect the function of limbs and daily life; (5) Those who agree to participate in the study and sign written informed consent.

Exclusion criteria

Exclusion criteria: (1) Proliferative scars caused by chemical burns/electric burns and other special causes such as burns, chronic wounds, and surgical incisions; keloids or atrophic scars are clearly diagnosed; (2) Severe malnutrition, albumin 38.5 degree C or white blood cells > 12 x10^9/L or marked with local inflammation; (4) Patients with severe systemic infections who require systemic antibiotic treatment; (5) Patients with tumor, radiotherapy or chemotherapy; (6) Patients with serious primary diseases such as cardiovascular, liver, kidney and blood system, and mental patients; (7) It is known that the components or other chemical structures contained in the artificial dermal scaffold have a history of allergies or allergies; (8) Pregnant or lactating women and those with birth plans; (9) Those who have participated in other clinical research within one month prior to the election; (10) Some other investigators believe that it is not appropriate to participate in clinical research.

Design outcomes

Primary

MeasureTime frame
Clinical treatment time for wound closure after scar resection;Long-term outcome after scar removal, Scar Assessment Scale (POSAS);

Countries

China

Contacts

Public ContactZhu Shihui

Department of Burns, Shanghai Changhai Hospital

Doctorzhushihui@163.com+86 13901971974

Outcome results

None listed

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