Trial Outcomes & Findings for The Use of Integra in Coverage of Radial Forearm Free Flap Donor Site Defect (NCT NCT02980601)

Results Overview

Number of participants with skin graft necrosis.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

10 participants

Primary outcome timeframe

1 year

Results posted on

2019-05-24

Participant Flow

Participant milestones

Participant milestones
Measure	Integra and a Split Thickness Skin Graft (STSG) A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG. Integra plus STSG: A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG STSG: 0.012mm STSG	Split Thickness Skin Graft (STSG) reconstruction as dictated by the protocol. They will either receive 1) a 0 STSG: 0.012mm STSG
Overall Study STARTED	6	4
Overall Study COMPLETED	1	1
Overall Study NOT COMPLETED	5	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Integra and a Split Thickness Skin Graft (STSG) A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG. Integra plus STSG: A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG STSG: 0.012mm STSG	Split Thickness Skin Graft (STSG) reconstruction as dictated by the protocol. They will either receive 1) a 0 STSG: 0.012mm STSG
Overall Study Lost to Follow-up	2	2
Overall Study Death	0	1
Overall Study Graft loss	1	0
Overall Study Failed to sign consent	2	0

Baseline Characteristics

The Use of Integra in Coverage of Radial Forearm Free Flap Donor Site Defect

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: 1 year

Number of participants with skin graft necrosis.

Outcome measures

Outcome measures
Measure	Integra and a Split Thickness Skin Graft (STSG) n=6 Participants A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG. Integra plus STSG: A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG STSG: 0.012mm STSG	Split Thickness Skin Graft (STSG) n=4 Participants reconstruction as dictated by the protocol. They will either receive 1) a 0 STSG: 0.012mm STSG
Number of Participants With Skin Graft Necrosis.	2 participants	1 participants

PRIMARY outcome

Timeframe: 1 Year

Population: Data not collected

The Vancouver Scar Scale will measure donor site aesethetic quality and it encompasses 4 separate outcomes to be objectively assessed. Each has been separately reported in the literature for each group in different papers as previously mentioned. We will compare the final score as well as scores within each outcome.On a scale of 1-13; with higher score denoting worse outcome.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 1 year

Population: Data not collected

Pigmentation will be measured on the Vancouver Scar Scale. On a scale of 0-2; higher score denoting worse outcome.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 1 year

Population: Data not collected

Vascularity will be measured on the Vancouver Scar Scale. On a scale of 0-3; higher score denoting worse outcome.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 1 year

Population: Data not collected

Pliability will be measured on the Vancouver Scar Scale. On a scale of 1-5; higher score denoting worse outcome.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 1 year

Population: Data not collected

Height will be measured on the Vancouver Scar Scale. On a scale of 0-3; higher score denoting worse outcome.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Pre-op

Functional outcomes will be measured by using strength dynamometers.

Outcome measures

Outcome measures
Measure	Integra and a Split Thickness Skin Graft (STSG) n=6 Participants A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG. Integra plus STSG: A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG STSG: 0.012mm STSG	Split Thickness Skin Graft (STSG) n=4 Participants reconstruction as dictated by the protocol. They will either receive 1) a 0 STSG: 0.012mm STSG
Hand Strength -Lateral Pinch	19.4 Lbs Standard Deviation 4.176123	21.25 Lbs Standard Deviation 2.165064

PRIMARY outcome

Timeframe: 3 month

Functional outcomes will be measured by using strength dynamometers.

Outcome measures

Outcome measures
Measure	Integra and a Split Thickness Skin Graft (STSG) n=6 Participants A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG. Integra plus STSG: A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG STSG: 0.012mm STSG	Split Thickness Skin Graft (STSG) n=4 Participants reconstruction as dictated by the protocol. They will either receive 1) a 0 STSG: 0.012mm STSG
Hand Strength -Lateral Pinch	14.57142857 Lbs Standard Deviation 4.655477353	16.8 Lbs Standard Deviation 3.059411708

PRIMARY outcome

Timeframe: 6 months

Functional outcomes will be measured by using strength dynamometers.

Outcome measures

Outcome measures
Measure	Integra and a Split Thickness Skin Graft (STSG) n=6 Participants A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG. Integra plus STSG: A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG STSG: 0.012mm STSG	Split Thickness Skin Graft (STSG) n=4 Participants reconstruction as dictated by the protocol. They will either receive 1) a 0 STSG: 0.012mm STSG
Hand Strength -Lateral Pinch	15.8 Lbs Standard Deviation 4.833218389	19.33333333 Lbs Standard Deviation 2.494438258

PRIMARY outcome

Timeframe: 1 year

Population: Data not recorded.

Functional outcomes will be measured by using strength dynamometers.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: pre-op

Functional outcomes will be measured by using strength dynamometers.

Outcome measures

Outcome measures
Measure	Integra and a Split Thickness Skin Graft (STSG) n=6 Participants A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG. Integra plus STSG: A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG STSG: 0.012mm STSG	Split Thickness Skin Graft (STSG) n=4 Participants reconstruction as dictated by the protocol. They will either receive 1) a 0 STSG: 0.012mm STSG
Hand Strength - Grip	72.4 Lbs Standard Deviation 19.82523644	79.25 Lbs Standard Deviation 16.02146997

PRIMARY outcome

Timeframe: 3 month

Functional outcomes will be measured by using strength dynamometers.

Outcome measures

Outcome measures
Measure	Integra and a Split Thickness Skin Graft (STSG) n=6 Participants A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG. Integra plus STSG: A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG STSG: 0.012mm STSG	Split Thickness Skin Graft (STSG) n=4 Participants reconstruction as dictated by the protocol. They will either receive 1) a 0 STSG: 0.012mm STSG
Hand Strength - Grip	58.14285714 Lbs Standard Deviation 22.94358654	66.4 Lbs Standard Deviation 21.81375713

PRIMARY outcome

Timeframe: 6 month

Functional outcomes will be measured by using strength dynamometers.

Outcome measures

Outcome measures
Measure	Integra and a Split Thickness Skin Graft (STSG) n=6 Participants A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG. Integra plus STSG: A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG STSG: 0.012mm STSG	Split Thickness Skin Graft (STSG) n=4 Participants reconstruction as dictated by the protocol. They will either receive 1) a 0 STSG: 0.012mm STSG
Hand Strength - Grip	66.4 Lbs Standard Deviation 25.49195952	81.66666667 Lbs Standard Deviation 16.49915823

PRIMARY outcome

Timeframe: 1 year

Population: Data not collected

Functional outcomes will be measured by using strength dynamometers.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: pre-op

Functional outcomes will be measured by using strength dynamometers

Outcome measures

Outcome measures
Measure	Integra and a Split Thickness Skin Graft (STSG) n=6 Participants A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG. Integra plus STSG: A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG STSG: 0.012mm STSG	Split Thickness Skin Graft (STSG) n=4 Participants reconstruction as dictated by the protocol. They will either receive 1) a 0 STSG: 0.012mm STSG
Hand Strength- Pincer	13.4 Lbs Standard Deviation 4.176122604	14.75 Lbs Standard Deviation 3.561951712

PRIMARY outcome

Timeframe: 3 month

Functional outcomes will be measured by using strength dynamometers

Outcome measures

Outcome measures
Measure	Integra and a Split Thickness Skin Graft (STSG) n=6 Participants A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG. Integra plus STSG: A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG STSG: 0.012mm STSG	Split Thickness Skin Graft (STSG) n=4 Participants reconstruction as dictated by the protocol. They will either receive 1) a 0 STSG: 0.012mm STSG
Hand Strength- Pincer	11 Lbs Standard Deviation 5.318431563	12.2 Lbs Standard Deviation 5.306599665

PRIMARY outcome

Timeframe: 6 month

Functional outcomes will be measured by using strength dynamometers

Outcome measures

Outcome measures
Measure	Integra and a Split Thickness Skin Graft (STSG) n=6 Participants A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG. Integra plus STSG: A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG STSG: 0.012mm STSG	Split Thickness Skin Graft (STSG) n=4 Participants reconstruction as dictated by the protocol. They will either receive 1) a 0 STSG: 0.012mm STSG
Hand Strength- Pincer	13.4 Lbs Standard Deviation 4.079215611	16 Lbs Standard Deviation 3.265986324

PRIMARY outcome

Timeframe: 1 year

Population: Data not collected

Functional outcomes will be measured by using strength dynamometers

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: pre-op

Functional outcomes will be measured by using electric goniometers so as to standardize the measurements. Wrist flexion and wrist extension

Outcome measures

Outcome measures
Measure	Integra and a Split Thickness Skin Graft (STSG) n=6 Participants A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG. Integra plus STSG: A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG STSG: 0.012mm STSG	Split Thickness Skin Graft (STSG) n=4 Participants reconstruction as dictated by the protocol. They will either receive 1) a 0 STSG: 0.012mm STSG
Wrist Range of Motion- Flexion	72.83333333 degrees Standard Deviation 15.44254585	68 degrees Standard Deviation 16.02146997

PRIMARY outcome

Timeframe: 3 month

Functional outcomes will be measured by using electric goniometers so as to standardize the measurements. Wrist flexion and wrist extension

Outcome measures

Outcome measures
Measure	Integra and a Split Thickness Skin Graft (STSG) n=6 Participants A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG. Integra plus STSG: A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG STSG: 0.012mm STSG	Split Thickness Skin Graft (STSG) n=4 Participants reconstruction as dictated by the protocol. They will either receive 1) a 0 STSG: 0.012mm STSG
Wrist Range of Motion- Flexion	66.42857143 degrees Standard Deviation 13.55261854	69 degrees Standard Deviation 12

PRIMARY outcome

Timeframe: 6 month

Functional outcomes will be measured by using electric goniometers so as to standardize the measurements. Wrist flexion and wrist extension

Outcome measures

Outcome measures
Measure	Integra and a Split Thickness Skin Graft (STSG) n=6 Participants A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG. Integra plus STSG: A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG STSG: 0.012mm STSG	Split Thickness Skin Graft (STSG) n=4 Participants reconstruction as dictated by the protocol. They will either receive 1) a 0 STSG: 0.012mm STSG
Wrist Range of Motion- Flexion	59.8 degrees Standard Deviation 11.66876172	68.333333 degrees Standard Deviation 6.236095645

PRIMARY outcome

Timeframe: 1 year

Population: Data not collected

Functional outcomes will be measured by using electric goniometers so as to standardize the measurements. Wrist flexion and wrist extension

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: pre-op

Functional outcomes will be measured by using electric goniometers so as to standardize the measurements. Wrist flexion and wrist extension

Outcome measures

Outcome measures
Measure	Integra and a Split Thickness Skin Graft (STSG) n=6 Participants A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG. Integra plus STSG: A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG STSG: 0.012mm STSG	Split Thickness Skin Graft (STSG) n=4 Participants reconstruction as dictated by the protocol. They will either receive 1) a 0 STSG: 0.012mm STSG
Wrist Range of Motion- Extension	57.33333333 degrees Standard Deviation 9.689627902	49.66666667 degrees Standard Deviation 7.758060325

PRIMARY outcome

Timeframe: 3 month

Functional outcomes will be measured by using electric goniometers so as to standardize the measurements. Wrist flexion and wrist extension

Outcome measures

Outcome measures
Measure	Integra and a Split Thickness Skin Graft (STSG) n=6 Participants A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG. Integra plus STSG: A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG STSG: 0.012mm STSG	Split Thickness Skin Graft (STSG) n=4 Participants reconstruction as dictated by the protocol. They will either receive 1) a 0 STSG: 0.012mm STSG
Wrist Range of Motion- Extension	45 degrees Standard Deviation 15.58387445	47.5 degrees Standard Deviation 13.78404875

PRIMARY outcome

Timeframe: 6 month

Functional outcomes will be measured by using electric goniometers so as to standardize the measurements. Wrist flexion and wrist extension

Outcome measures

Outcome measures
Measure	Integra and a Split Thickness Skin Graft (STSG) n=6 Participants A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG. Integra plus STSG: A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG STSG: 0.012mm STSG	Split Thickness Skin Graft (STSG) n=4 Participants reconstruction as dictated by the protocol. They will either receive 1) a 0 STSG: 0.012mm STSG
Wrist Range of Motion- Extension	59.4 degrees Standard Deviation 21.10544953	70 degrees Standard Deviation 8.498365856

PRIMARY outcome

Timeframe: 1 year

Population: Data not collected

Functional outcomes will be measured by using electric goniometers so as to standardize the measurements. Wrist flexion and wrist extension

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 6 month

Tendon exposure identified clinically.

Outcome measures

Outcome measures
Measure	Integra and a Split Thickness Skin Graft (STSG) n=6 Participants A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG. Integra plus STSG: A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG STSG: 0.012mm STSG	Split Thickness Skin Graft (STSG) n=4 Participants reconstruction as dictated by the protocol. They will either receive 1) a 0 STSG: 0.012mm STSG
Number of Participant With Tendon Exposure	2 participants	1 participants

PRIMARY outcome

Timeframe: 1 year

Population: Data not collected

Tendon exposure identified clinically.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 3 month

Population: Data not collected

Presence of paresthesia on a 1-10 scale , higher score denote worse outcomes

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 6 month

Population: Data not collected

Presence of paresthesia on a 1-10 scale , higher score denote worse outcomes

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 1 year

Population: Data not collected

Presence of paresthesia on a 1-10 scale , higher score denote worse outcomes

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: pre-op

Population: Data not collected

Functional outcome as measured by pre and post operative assessment on the QuickDASH scale. On a scale of 0-100; with higher score denotes worse outcome measure

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 3 month

Functional outcome as measured by pre and post operative assessment on the QuickDASH scale. On a scale of 0-100; with higher score denotes worse outcome measure

Outcome measures

Outcome measures
Measure	Integra and a Split Thickness Skin Graft (STSG) n=6 Participants A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG. Integra plus STSG: A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG STSG: 0.012mm STSG	Split Thickness Skin Graft (STSG) n=4 Participants reconstruction as dictated by the protocol. They will either receive 1) a 0 STSG: 0.012mm STSG
The Disabilities of the Arm, Shoulder and Hand (QuickDASH) Questionnaire)	27.43333333 score on a scale Standard Deviation 18.01894065	29.525 score on a scale Standard Deviation 23.13118836

PRIMARY outcome

Timeframe: 6 month

Functional outcome as measured by pre and post operative assessment on the QuickDASH scale. On a scale of 0-100; with higher score denotes worse outcome measure

Outcome measures

Outcome measures
Measure	Integra and a Split Thickness Skin Graft (STSG) n=6 Participants A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG. Integra plus STSG: A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG STSG: 0.012mm STSG	Split Thickness Skin Graft (STSG) n=4 Participants reconstruction as dictated by the protocol. They will either receive 1) a 0 STSG: 0.012mm STSG
The Disabilities of the Arm, Shoulder and Hand (QuickDASH) Questionnaire)	-3.636363636 score on a scale Standard Deviation 26.31264662	-9.090909091 score on a scale Standard Deviation 16.62356686

PRIMARY outcome

Timeframe: 1 year

Population: data not recorded for all subjects

Functional outcome as measured by pre and post operative assessment on the QuickDASH scale. On a scale of 0-100; with higher score denotes worse outcome measure

Outcome measures

Outcome measures
Measure	Integra and a Split Thickness Skin Graft (STSG) n=1 Participants A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG. Integra plus STSG: A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG STSG: 0.012mm STSG	Split Thickness Skin Graft (STSG) reconstruction as dictated by the protocol. They will either receive 1) a 0 STSG: 0.012mm STSG
The Disabilities of the Arm, Shoulder and Hand (QuickDASH) Questionnaire)	5 score on a scale Standard Deviation 11.056672193748	—

PRIMARY outcome

Timeframe: 3 month

Population: data not recorded

Planimetry Software will be used to measure and determine percentage of wound contracture

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 6 month

Population: data not recorded

Planimetry Software will be used to measure and determine percentage of wound contracture

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 1 year

Population: data not recorded

Planimetry Software will be used to measure and determine percentage of wound contracture

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 1 year

Population: Data not collected

Skin pliability will be measuredusing a Cutometer MPA 580. We plan to measure Pliability (Ua), Elasticity (Ue), Retraction (Ur). Viscoelasticity (Uv), and Extension (Uf).

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 month

Total score (20-200). Higher scores denote worse outcomes.

Outcome measures

Outcome measures
Measure	Integra and a Split Thickness Skin Graft (STSG) n=6 Participants A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG. Integra plus STSG: A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG STSG: 0.012mm STSG	Split Thickness Skin Graft (STSG) n=4 Participants reconstruction as dictated by the protocol. They will either receive 1) a 0 STSG: 0.012mm STSG
Patient Scar Assessment	86.14285714 score on a scale Standard Deviation 26.03529786	82.25 score on a scale Standard Deviation 27.72521416

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 month

Total score (20-200). Higher scores denote worse outcomes.

Outcome measures

Outcome measures
Measure	Integra and a Split Thickness Skin Graft (STSG) n=6 Participants A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG. Integra plus STSG: A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG STSG: 0.012mm STSG	Split Thickness Skin Graft (STSG) n=4 Participants reconstruction as dictated by the protocol. They will either receive 1) a 0 STSG: 0.012mm STSG
Patient Scar Assessment	89.8 score on a scale Standard Deviation 78.170071	65.5 score on a scale Standard Deviation 20.5

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 year

Total score (20-200). Higher scores denote worse outcomes.

Outcome measures

Outcome measures
Measure	Integra and a Split Thickness Skin Graft (STSG) n=6 Participants A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG. Integra plus STSG: A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG STSG: 0.012mm STSG	Split Thickness Skin Graft (STSG) n=4 Participants reconstruction as dictated by the protocol. They will either receive 1) a 0 STSG: 0.012mm STSG
Patient Scar Assessment	24.5 score on a scale Standard Deviation 3.5	28 score on a scale Standard Deviation 0

Adverse Events

Integra and a Split Thickness Skin Graft (STSG)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Split Thickness Skin Graft (STSG)

Serious events: 1 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Integra and a Split Thickness Skin Graft (STSG) n=6 participants at risk A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG. Integra plus STSG: A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG STSG: 0.012mm STSG	Split Thickness Skin Graft (STSG) n=4 participants at risk reconstruction as dictated by the protocol. They will either receive 1) a 0 STSG: 0.012mm STSG
General disorders Subject deceased	0.00% 0/6 • Data was collected during the 1 year of study activities. Definitions do not differ.	25.0% 1/4 • Number of events 1 • Data was collected during the 1 year of study activities. Definitions do not differ.

Other adverse events

Adverse event data not reported

Additional Information

Joseph Molnar

Wake Forest Baptist Health

Phone: 336-716-4171

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Integra and a Split Thickness Skin Graft (STSG) n=6 Participants A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG. Integra plus STSG: A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG STSG: 0.012mm STSG	Split Thickness Skin Graft (STSG) n=4 Participants reconstruction as dictated by the protocol. They will either receive 1) a 0 STSG: 0.012mm STSG	Total n=10 Participants Total of all reporting groups
Sex: Female, Male Male	5 Participants n=5 Participants	3 Participants n=7 Participants	8 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
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 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
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	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	1 Participants n=7 Participants	2 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	6 Participants n=5 Participants	4 Participants n=7 Participants	10 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