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Comparison of the retraction of 3 Dermis Substitutes used to treat Burn Sequelae

Prospective, randomized, controlled study of Burn Sequelae comparing late Retraction between three dermal matrices: Integra®, Matriderm® and Pelnac®

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-62p5rf
Enrollment
Unknown
Registered
2018-06-12
Start date
2016-10-15
Completion date
Unknown
Last updated
2025-10-27

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

Conditions

Sequelae of burns, corrodes and frostbite / sequela burns

Interventions

The interventions in each group will be carried out as follows: 1. Dermal matrix of bovine origin in 2 times: 10 patients with sequelae of burns
procedures will occur in two times, the first time for resection and / or release of the cicatricial sequelae and placement of the matrix, and the second time will be performed 21 days later. On this
procedures will occur in two times, being the first time for resection and / or release of the cicatricial sequel and placement of matrize. And the second time will be done 21 days later. At this time
procedures will occur at a time where resection and / or release of the cicatricial sequestration is performed, placement of the matrix followed by apposition of the partial skin graft onto the matrix
procedures will occur at a time where resection and / or release of the cicatricial sequestration will be performed, placement of the partial skin graft over the bed. All skin grafts will be removed
Procedure/surgery
Q65.070

Sponsors

Hospital das Clínicas de Ribeirão Preto
Lead Sponsor
Hospital das Clínicas de Ribeirão Preto
Collaborator

Eligibility

Age
No minimum to 99 Years

Inclusion criteria

Inclusion criteria: Patients from the burn outpatient clinic of the Burn Unit of the HCFMRP-USP who had some chronic burn como sequela associated with aesthetic impairment; functional restriction; unstable scars or Marjolin's ulcer (carcinomatous degeneration); with at least 1 year post-burn follow-up ; in which surgical correction with partial skin graft was indicated.

Exclusion criteria

Exclusion criteria: Patients who lost a more than 10% of the partial skin graft, or patients who had any restrictions on the use of dermal matrix (such as allergy to any component present in the product), were excluded.

Design outcomes

Primary

MeasureTime frame
Reduction of the contraction rate (1,3,6 and 12 months) of the grafts using the dermal matrices when compared to the control case in burn sequelae, with measurement of the graft area using the Image J software from the a statistically significant lower contraction assuming a 95% confidence interval.

Secondary

MeasureTime frame
secondary outcomes are not expected

Countries

Brazil

Contacts

Public ContactFernanda Corrêa

Hospital das Clínicas de Ribeirão Preto

nandarp2016@gmail.com+55-016-996295266

Outcome results

None listed

Source: REBEC (via WHO ICTRP)