Trial Outcomes & Findings for StrataGraft® Skin Tissue as an Alternative to Autografting Full-thickness Complex Skin Defects (NCT NCT03005054)

NCT ID: NCT03005054

Last Updated: 2021-08-03

Results Overview

The percentage of the treatment site area initially covered with StrataGraft tissue that requires autograft by three months will be determined.

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 3 participants
• Primary outcome timeframe: 3 months
• Results posted on: 2021-08-03

Participant Flow

Participant milestones

Measure	StrataGraft Skin Tissue StrataGraft Skin Tissue: StrataGraft® skin tissue is provided as a suturable rectangular piece of stratified epithelial tissue composed of a living dermal matrix containing dermal fibroblasts overlaid with human epidermal keratinocytes (NIKS®). Autograft: The current standard of care procedure for the treatment of severe complex skin defects. The procedure involves the removal of a sheet of healthy skin from an uninjured site on the patient and using it to cover the original wound.
Overall Study STARTED	3
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

StrataGraft® Skin Tissue as an Alternative to Autografting Full-thickness Complex Skin Defects

Baseline characteristics by cohort

Measure	StrataGraft Skin Tissue n=3 Participants StrataGraft Skin Tissue: StrataGraft® skin tissue is provided as a suturable rectangular piece of stratified epithelial tissue composed of a living dermal matrix containing dermal fibroblasts overlaid with human epidermal keratinocytes (NIKS®). Autograft: The current standard of care procedure for the treatment of severe complex skin defects. The procedure involves the removal of a sheet of healthy skin from an uninjured site on the patient and using it to cover the original wound.
Age, Continuous	53 years n=93 Participants
Sex: Female, Male Female	3 Participants n=93 Participants
Sex: Female, Male Male	0 Participants n=93 Participants
Race/Ethnicity, Customized White · Not Hispanic or Latino	3 Participants n=93 Participants
Race/Ethnicity, Customized White · Hispanic or Latino	0 Participants n=93 Participants
Region of Enrollment United States	3 participants n=93 Participants

PRIMARY outcome

Timeframe: 3 months

Population: All participants

The percentage of the treatment site area initially covered with StrataGraft tissue that requires autograft by three months will be determined.

Outcome measures

Measure	StrataGraft Skin Tissue n=3 Participants StrataGraft Skin Tissue: StrataGraft® skin tissue is provided as a suturable rectangular piece of stratified epithelial tissue composed of a living dermal matrix containing dermal fibroblasts overlaid with human epidermal keratinocytes (NIKS®). Autograft: The current standard of care procedure for the treatment of severe complex skin defects. The procedure involves the removal of a sheet of healthy skin from an uninjured site on the patient and using it to cover the original wound.
Percent Area of the StrataGraft Treatment Site Requiring Autografting by Three Months Participant 1	100 percentage of treatment site
Percent Area of the StrataGraft Treatment Site Requiring Autografting by Three Months Participant 2	25 percentage of treatment site
Percent Area of the StrataGraft Treatment Site Requiring Autografting by Three Months Participant 3	125 percentage of treatment site

PRIMARY outcome

Timeframe: 3 months

Population: All participants

Complete wound closure is defined as ≥95% re-epithelialization of all treatment sites with the absence of drainage

Outcome measures

Measure

StrataGraft Skin Tissue n=3 Participants StrataGraft Skin Tissue: StrataGraft® skin tissue is provided as a suturable rectangular piece of stratified epithelial tissue composed of a living dermal matrix containing dermal fibroblasts overlaid with human epidermal keratinocytes (NIKS®). Autograft: The current standard of care procedure for the treatment of severe complex skin defects. The procedure involves the removal of a sheet of healthy skin from an uninjured site on the patient and using it to cover the original wound.

Percentage of Participants With Complete Wound Closure of the Treatment Sites at Three Months

100 percentage of participants

SECONDARY outcome

Timeframe: within 3 months

Population: Data were not collected

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: within 3, 6 and 12 months

Population: Data were not collected

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: within 3, 6, and 12 Months

Population: Data were not collected

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: within 3, 6, and 12 Months

Population: Data were not collected

Cosmesis is defined as the preservation, restoration, or enhancement of physical appearance

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: within 3, 6, and 12 Months

Population: Data were not collected

Cosmesis is defined as the preservation, restoration, or enhancement of physical appearance

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: at days 3, 7, 14, 21, and 28

Population: Data were not collected

Outcome measures

Outcome data not reported

Adverse Events

StrataGraft Skin Tissue

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Measure

StrataGraft Skin Tissue n=3 participants at risk StrataGraft Skin Tissue: StrataGraft® skin tissue is provided as a suturable rectangular piece of stratified epithelial tissue composed of a living dermal matrix containing dermal fibroblasts overlaid with human epidermal keratinocytes (NIKS®). Autograft: The current standard of care procedure for the treatment of severe complex skin defects. The procedure involves the removal of a sheet of healthy skin from an uninjured site on the patient and using it to cover the original wound.

Injury, poisoning and procedural complications Graft complication

33.3% 1/3 • 3 months Tables reflect treatment-emergent adverse events (TEAEs). If a subject has more than one incidence of a preferred term, the subject is counted only once for that preferred term.

Other adverse events

Measure	StrataGraft Skin Tissue n=3 participants at risk StrataGraft Skin Tissue: StrataGraft® skin tissue is provided as a suturable rectangular piece of stratified epithelial tissue composed of a living dermal matrix containing dermal fibroblasts overlaid with human epidermal keratinocytes (NIKS®). Autograft: The current standard of care procedure for the treatment of severe complex skin defects. The procedure involves the removal of a sheet of healthy skin from an uninjured site on the patient and using it to cover the original wound.
Injury, poisoning and procedural complications Graft complication	66.7% 2/3 • 3 months Tables reflect treatment-emergent adverse events (TEAEs). If a subject has more than one incidence of a preferred term, the subject is counted only once for that preferred term.
Infections and infestations Fungal skin infection	33.3% 1/3 • 3 months Tables reflect treatment-emergent adverse events (TEAEs). If a subject has more than one incidence of a preferred term, the subject is counted only once for that preferred term.
Infections and infestations Pneumonia	33.3% 1/3 • 3 months Tables reflect treatment-emergent adverse events (TEAEs). If a subject has more than one incidence of a preferred term, the subject is counted only once for that preferred term.
Blood and lymphatic system disorders Thrombocytopenia	33.3% 1/3 • 3 months Tables reflect treatment-emergent adverse events (TEAEs). If a subject has more than one incidence of a preferred term, the subject is counted only once for that preferred term.
Endocrine disorders Hyperglycaemia	33.3% 1/3 • 3 months Tables reflect treatment-emergent adverse events (TEAEs). If a subject has more than one incidence of a preferred term, the subject is counted only once for that preferred term.
Eye disorders Cataract	33.3% 1/3 • 3 months Tables reflect treatment-emergent adverse events (TEAEs). If a subject has more than one incidence of a preferred term, the subject is counted only once for that preferred term.
General disorders Pain	33.3% 1/3 • 3 months Tables reflect treatment-emergent adverse events (TEAEs). If a subject has more than one incidence of a preferred term, the subject is counted only once for that preferred term.
Psychiatric disorders Anxiety	33.3% 1/3 • 3 months Tables reflect treatment-emergent adverse events (TEAEs). If a subject has more than one incidence of a preferred term, the subject is counted only once for that preferred term.
Psychiatric disorders Depression	33.3% 1/3 • 3 months Tables reflect treatment-emergent adverse events (TEAEs). If a subject has more than one incidence of a preferred term, the subject is counted only once for that preferred term.
Skin and subcutaneous tissue disorders Blister	33.3% 1/3 • 3 months Tables reflect treatment-emergent adverse events (TEAEs). If a subject has more than one incidence of a preferred term, the subject is counted only once for that preferred term.
Skin and subcutaneous tissue disorders Excessive granulation tissue	33.3% 1/3 • 3 months Tables reflect treatment-emergent adverse events (TEAEs). If a subject has more than one incidence of a preferred term, the subject is counted only once for that preferred term.

Additional Information

Medical Information Call Center

Mallinckrodt

Phone: 800-844-2830

Email: clinicaltrials@mnk.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place