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Randomized, controlled clinical trial on use of allogeneic keratinocytes and fibroblasts delivery sheet to treat burn trauma and chronic wound

Randomized, controlled clinical trial on use of allogeneic keratinocytes and fibroblasts delivery sheet to treat burn trauma and chronic wound

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-INR-17010705
Enrollment
Unknown
Registered
2017-02-22
Start date
2017-03-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

burn trauma & chronic wound

Interventions

cell sheet graft treatment:cell sheet graft treatment
sulfadiazine silver treatment: sulfadiazine silver and tuojiagao control treatment

Sponsors

Changhai Hospital of Second Military Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Full-thickness trauma, 1~30% TBSA, the single observable wound bed is no less than 10×10 cm2, and no more than 10% TBSA; 2. Male and female aged 1~60 years; 3. Outpatient and inpatient, within 5 days of injury; 4. Childbearing-age woman need practice contraception; 5. Informed consent form is fully understood and signed for patients.

Exclusion criteria

Exclusion criteria: 1. HIV1,HIV2,HBV,HCV,HTLV1 or syphilis positive; 2. diabetic, malignant tumor or chronic wasting disease patient; 3. severe heart, liver, kidney and blood system complication; 4. using recombination human epidermal growth factor patient; 5. immune disease or hormone therapy patient; 6. pregnant or nursing women or supposed to be pregnant during clinical trial; 7. Physical or psychical situation are not suitable for clinical trial; 8. severe part or full body infection that are hard to control; or having active tuberculosis history or being active tuberculosis patient; 9. under other drug or medical instrument clinical trial within 30 days. Positive findings on test for HIV1, HIV2, HBV, HCV, HTLV1, or Syphilis; Patients were excluded if they had actively infected foot ulcers, significant lower extremity ischaemia: foot pulses (dorsalis pedis, posterior tibialis) on the affected foot were impalpable, acute Charcots disease or if they were judged not to be sufficiently compliant with the recommendations concerning off-loading and the regularity of the TranCell dressin.

Design outcomes

Primary

MeasureTime frame
the healing rate;

Secondary

MeasureTime frame
the healing time;pain visual analog scales;

Countries

China

Contacts

Public ContactShichu Xiao

Shanghai Changhai Hospital

huangzhuoxiao4@hotmail.com+86 18516100391

Outcome results

None listed

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