Comparing three different materials to treat large, deep burns: a one year follow-up

Comparing Integra, a cellulose sponge and split thickness skin graft in the treatment of large, deep third degree burns in adults: a one year follow-up of a prospective randomised controlled trial.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN14499986

Enrollment

Registered

2019-01-16

Start date

2000-05-01

Completion date

Unknown

Last updated

2023-03-13

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

Conditions

Third degree burns Injury, Occupational Diseases, Poisoning Burn of third degree, body region unspecified

Interventions

Ten burn patients with > 20 % total body surface area deep burns had a test area 15x10 cm of a fascially excised burn wound on the anterior side of the body. Test area was divided into three sections

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Participants: 1. Aged between 17 and 70 years 2. Total burned surface area (TBSA) over 20% 3. Burns located on the anterior side of the body. Test areas: 1. Deep third degree burns requiring fascial excision.

Exclusion criteria

Exclusion criteria: Patients who did not survive the follow up time.

Design outcomes

Primary

Measure	Time frame
1. Clinical, cosmetic and functional outcomes were measured using the Vancouver Scar Scale 3 months and 12 months after primary surgery. 2. Differences in wound healing were measured histologically and immunohistochemically using biopsy samples from the test areas on days 3, 7, 14, and 21, 3 months and 12 months after primary surgery. The following biomarkers were measured: 2.1. HE 2.2. CD31 2.3. CD163 2.4. Alpha SMA 2.5. MIB1 2.6. collagen type IV 2.7. CASP14 2.8. DNAH10	—

Measure

Time frame

1. Clinical, cosmetic and functional outcomes were measured using the Vancouver Scar Scale 3 months and 12 months after primary surgery. 2. Differences in wound healing were measured histologically and immunohistochemically using biopsy samples from the test areas on days 3, 7, 14, and 21, 3 months and 12 months after primary surgery. The following biomarkers were measured: 2.1. HE 2.2. CD31 2.3. CD163 2.4. Alpha SMA 2.5. MIB1 2.6. collagen type IV 2.7. CASP14 2.8. DNAH10

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Secondary

Measure	Time frame
1. Long term differences in proteins were measured using proteomic analyses performed with Q Exactive Plus (ThermoFisher Scientific) mass-spectrometer operating with a top-5 MS/MS strategy. 1.1. Raw data were identified and quantified with MaxQuant 1.4.0.8 software package. 1.2. Search was performed against the UniProt (www.uniprot.org) human database using the tryptic digestion rule. 1.3. The findings of proteomics were validated with immunohistochemistry of DNAH10 and CASP14.	—

Measure

Time frame

1. Long term differences in proteins were measured using proteomic analyses performed with Q Exactive Plus (ThermoFisher Scientific) mass-spectrometer operating with a top-5 MS/MS strategy. 1.1. Raw data were identified and quantified with MaxQuant 1.4.0.8 software package. 1.2. Search was performed against the UniProt (www.uniprot.org) human database using the tryptic digestion rule. 1.3. The findings of proteomics were validated with immunohistochemistry of DNAH10 and CASP14.

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Countries

Finland

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 1, 2026