Trial Outcomes & Findings for Utility of Restrata With Split Thickness Skin Graft to Reconstruct the Forearm Donor Site (NCT NCT04829331)

NCT ID: NCT04829331

Last Updated: 2023-04-18

Results Overview

Percentage of participants with tendon exposure

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 5 participants
• Primary outcome timeframe: 4 weeks post-operatively
• Results posted on: 2023-04-18

Participant Flow

Participant milestones

Measure	Restrata With a Split-thickness Skin Graft Restrata: Restrata is a sterile, single use device intended for use in local management of wounds	Split-thickness Skin Graft Alone Split-thickness skin graft without Restrata
Overall Study STARTED	3	2
Overall Study COMPLETED	2	2
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Measure	Restrata With a Split-thickness Skin Graft Restrata: Restrata is a sterile, single use device intended for use in local management of wounds	Split-thickness Skin Graft Alone Split-thickness skin graft without Restrata
Overall Study Lost to Follow-up	1	0

Baseline Characteristics

Utility of Restrata With Split Thickness Skin Graft to Reconstruct the Forearm Donor Site

Baseline characteristics by cohort

Measure	Restrata With a Split-thickness Skin Graft n=3 Participants Restrata: Restrata is a sterile, single use device intended for use in local management of wounds	Split-thickness Skin Graft Alone n=2 Participants Split-thickness skin graft without Restrata	Total n=5 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Age, Continuous	69.3 years STANDARD_DEVIATION 4.5 • n=5 Participants	49.5 years STANDARD_DEVIATION 5.5 • n=7 Participants	61.4 years STANDARD_DEVIATION 9.5 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	3 participants n=5 Participants	2 participants n=7 Participants	5 participants n=5 Participants

PRIMARY outcome

Timeframe: 4 weeks post-operatively

Percentage of participants with tendon exposure

Outcome measures

Measure	Restrata With a Split-thickness Skin Graft n=3 Participants Restrata: Restrata is a sterile, single use device intended for use in local management of wounds	Split-thickness Skin Graft Alone n=2 Participants Split thickness graft without Restrata
Tendon Exposure % of patients with tendon exposure at 4 weeks	1 Participants	0 Participants
Tendon Exposure % patients lost to follow up prior to 4 weeks	1 Participants	0 Participants
Tendon Exposure % of patients with tendon coverage at 4 weeks	1 Participants	2 Participants

PRIMARY outcome

Timeframe: 4 weeks post-operatively

Percentage of surface area of split-thickness skin graft incorporation

Outcome measures

Measure	Restrata With a Split-thickness Skin Graft n=3 Participants Restrata: Restrata is a sterile, single use device intended for use in local management of wounds	Split-thickness Skin Graft Alone n=2 Participants Split thickness graft without Restrata
Surface Area of Split-thickness Skin Graft Incorporation 90% graft take	0 Participants	1 Participants
Surface Area of Split-thickness Skin Graft Incorporation % not assessed due to study termination	3 Participants	1 Participants

Adverse Events

Restrata With a Split-thickness Skin Graft

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Split-thickness Skin Graft Alone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Restrata With a Split-thickness Skin Graft n=3 participants at risk Restrata: Restrata is a sterile, single use device intended for use in local management of wounds	Split-thickness Skin Graft Alone n=2 participants at risk Split thickness graft without Restrata
Skin and subcutaneous tissue disorders Infection	33.3% 1/3 • Number of events 1 • 4 weeks after skin graft harvest	0.00% 0/2 • 4 weeks after skin graft harvest

Other adverse events

Adverse event data not reported

Additional Information

Matthew MacEwan

Acera Surgical

Phone: 440-477-1890

Email: macewan@acera-surgical.com

Results disclosure agreements

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