Permeaderm Versus Homograft for Full-thickness Burns

Full Thickness Burn Clinical Trial

Official title:

Biosynthetic Skin Substitute Versus Frozen Human Cadaver Allograft for Temporary Coverage of Excised Full-thickness Burn Wounds

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04673435
• Other study ID #: 16-0344
• Status: Withdrawn
• Phase: N/A
• Start date: January 31, 2018
• Est. completion date: July 31, 2020

Study information

• Verified date: December 2020
• Source: The University of Texas Medical Branch, Galveston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Frozen Human Cadaver Allograft (FHCA) is, nowadays, the gold standard for temporary coverage of excised full-thickness burns, but is also very expensive and requires additional personnel and major storage spaces in comparison to other products. The purpose of this study is to determine the extent to which PermeaDerm® dressing promotes wound bed maturation when used as a temporary dressing for excised full-thickness burn wounds. Efficacy and safety in promoting wound bed maturation for successive autografting will be determined through direct comparison to FHCA.

Description:

In this prospective, randomized, matched design pilot study, we aim to compare the current standard of care FHCA to PermeaDerm®.

30 patients for each study arm (n total = 60) meeting the inclusion criteria will be enrolled to randomly receive FHCA and PermeaDerm® on two adjacent or symmetric body areas.

Prior to randomization of study areas and application of study dressings, baseline assessments of wound size and burn depth will be performed by the experienced physician and documented using photography and when indicated laser Doppler (Moor Laser Speckle®, Moor Instruments, Devon, UK) measurements. Percentage of graft take and wound healing after removal of the temporary wound dressings and secondary autografting (study arm 1) or after excision and direct autografting with wiedely-meshed autograft and temporary wound dressings as overlay (study arm 2) will be assessed.

Secondary outcomes will include complications such as infections, signs of rejection/non-adherence, fluid accumulation/hematoma beneath dressings and mid- and long-term clinical scar maturation, as assessed by the POSAS and objectively with the DermaLab Combo® device (Cortex Technology ApS, Hadsund, Denmark).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 31, 2020
• Est. primary completion date: July 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months and older

Eligibility

Inclusion Criteria:

• = 2 % total body surface area (TBSA) full thickness burned.

• Patients with two adjacent or body symmetrical full thickness burned areas (each = 1 TBSA) and comparable in size (TBSA ± 0.5), that require debridement and autografting.

Exclusion Criteria:

• Time from injury to admission >= 5 days

• Sepsis on admission or clinically suspected infection (as per attending physician)

• Pregnancy or childbearing

• Positive HIV or hepatitis screens

• History of active malignancy

• Patients who do not require surgical debridement and autografting

• Patient with burn injuries originating from other causes (chemical, and frostbite)

Related Conditions & MeSH terms

• Burns
• Full Thickness Burn

Intervention

Device:
• PermeaDerm for temporary coverage
See above
• FHCA for temporary coverage
See above
• PermeaDerm over autograft
See above
• FHCA over autograft
see above

Locations

Country	Name	City	State
United States	University of texas Medical Branch Galveston	Galveston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Medical Branch, Galveston	Shriners Hospitals for Children

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to heal	Time until study areas are 95% healed, as rated by blinded assessors based on photographs	up to 8 weeks after initial grafting
Secondary	Incidence of adherence problems (Arm 2)	% of non-adherence at first dressing change	up to 21 days after initial surgery
Secondary	Incidence of adherence problems (Arm 1)	% of non-adherence at first dressing change and at time of dressing removal before grafting	up to 21 days after initial surgery
Secondary	Incidence of infections	Incidence of infection, defined as >10x5 bacteria/g tissue, Only taken when infection suspected.	up to 8 weeks after initial grafting
Secondary	Rate of fluid/hematoma accumulation	% of fluid accumulation/hematoma formation at first dressing change	up to 21 days after initial surgery
Secondary	Cost effectiveness	Price per cm square of each study dressing	Until grafting of study sites, within 21 days
Secondary	Scar assessment with Patient and Observer Assessment Scale (POSAS)	Using Patient and Observer Scar Assessment Scale POSAS, what is a composite score that is rating the overall appearance of the scar, based on each single score for rating vascularity, pigmentation, thickness, relief, pliability, surface. Every subscore ranges from 1-10. The composite score is calculated as an average of the subscores. Higher numbers mean worse scarring.	Assessed within 4 weeks after 95% wound healing
Secondary	Scar assessment with Patient and Observer Assessment Scale (POSAS)	Using Patient and Observer Scar Assessment Scale POSAS, what is a composite score that is rating the overall appearance of the scar, based on each single score for rating vascularity, pigmentation, thickness, relief, pliability, surface. Every subscore ranges from 1-10. The composite score is calculated as an average of the subscores. Higher numbers mean worse scarring.	Assessed between 3 and 9 months after initial admission
Secondary	Scar assessment with Patient and Observer Assessment Scale (POSAS)	Using Patient and Observer Scar Assessment Scale POSAS, what is a composite score that is rating the overall appearance of the scar, based on each single score for rating vascularity, pigmentation, thickness, relief, pliability, surface. Every subscore ranges from 1-10. The composite score is calculated as an average of the subscores. Higher numbers mean worse scarring.	Assessed between 9-15 months after initial admission
Secondary	Scarring with DermaLab Combo device: Viscoelasticity	Measured through negative suction and retraction time.	Assessed within 4 weeks after 95% wound healing
Secondary	Scarring with DermaLab Combo device: Viscoelasticity	Measured through negative suction and retraction time.	Assessed between 3 and 9 months after initial admission
Secondary	Scarring with DermaLab Combo device: Viscoelasticity	Measured through negative suction and retraction time.	Assessed between 9-15 months after initial admission
Secondary	Scarring with DermaLab Combo device: Hydration	Measured based on skin conductance.	Assessed within 4 weeks after 95% wound healing
Secondary	Scarring with DermaLab Combo device: Hydration	Measured based on skin conductance.	Assessed between 3 and 9 months after initial admission
Secondary	Scarring with DermaLab Combo device: Hydration	Measured based on skin conductance.	Assessed between 9-15 months after initial admission
Secondary	Scarring with DermaLab Combo device: Pigmentation	Measured based on light absorption of melanin and erythema	Assessed within 4 weeks after 95% wound healing
Secondary	Scarring with DermaLab Combo device: Pigmentation	Measured based on light absorption of melanin and erythema	Assessed between 3 and 9 months after initial admission
Secondary	Scarring with DermaLab Combo device: Pigmentation	Measured based on light absorption of melanin and erythema	Assessed between 9-15 months after initial admission
Secondary	Scarring with DermaLab Combo device: Trans epithermal water loss	Measuring evaporation in g/meter square/hour	Assessed within 4 weeks after 95% wound healing
Secondary	Scarring with DermaLab Combo device: Trans epithermal water loss	Measuring evaporation in g/meter square/hour	Assessed between 3 and 9 months after initial admission
Secondary	Scarring with DermaLab Combo device: Trans epithermal water loss	Measuring evaporation in g/meter square/hour	Assessed between 9-15 months after initial admission