Trial Outcomes & Findings for Cryopreserved vs. Lyopreserved Stravix as an Adjunct to NPWT in the Treatment of Complex Wounds (NCT NCT04405765)

NCT ID: NCT04405765

Last Updated: 2023-07-24

Results Overview

Number of patients who achieve wound closure (complete epithelialization with no drainage)

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 46 participants
• Primary outcome timeframe: 12 weeks
• Results posted on: 2023-07-24

Participant Flow

Participant milestones

Measure	Lyopreserved Stravix Treated with NPWT and lyopreserved Stravix NPWT and lyopreserved Stravix: Subjects will be treated with NPWT and lyopreserved Stravix	Cryopreserved Stravix Treated with NPWT and cryopreserved Stravix NPWT and cryopreserved Stravix: Subjects will be treated with NPWT and lyopreserved Stravix
Overall Study STARTED	22	20
Overall Study COMPLETED	21	19
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Cryopreserved vs. Lyopreserved Stravix as an Adjunct to NPWT in the Treatment of Complex Wounds

Baseline characteristics by cohort

Measure	Lyopreserved Stravix n=21 Participants Treated with NPWT and lyopreserved Stravix NPWT and lyopreserved Stravix: Subjects will be treated with NPWT and lyopreserved Stravix	Cryopreserved Stravix n=19 Participants Treated with NPWT and cryopreserved Stravix NPWT and cryopreserved Stravix: Subjects will be treated with NPWT and lyopreserved Stravix	Total n=40 Participants Total of all reporting groups
Age, Continuous	50.5 years STANDARD_DEVIATION 11.5 • n=5 Participants	55.4 years STANDARD_DEVIATION 6.4 • n=7 Participants	52.85 years STANDARD_DEVIATION 9.7 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants	16 Participants n=7 Participants	33 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	5 Participants n=5 Participants	1 Participants n=7 Participants	6 Participants n=5 Participants
Race/Ethnicity, Customized African American	6 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	10 Participants n=5 Participants	9 Participants n=7 Participants	19 Participants n=5 Participants
Race/Ethnicity, Customized Other	0 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Number of patients who achieve wound closure (complete epithelialization with no drainage)

Outcome measures

Measure	Lyopreserved Stravix n=21 Participants Treated with NPWT and lyopreserved Stravix NPWT and lyopreserved Stravix: Subjects will be treated with NPWT and lyopreserved Stravix	Cryopreserved Stravix n=19 Participants Treated with NPWT and cryopreserved Stravix NPWT and cryopreserved Stravix: Subjects will be treated with NPWT and lyopreserved Stravix
Complete Wound Closure	4 Participants	7 Participants

SECONDARY outcome

Timeframe: 12 weeks

Number of days patient received negative pressure wound therapy after application of Stravix

Outcome measures

Measure	Lyopreserved Stravix n=21 Participants Treated with NPWT and lyopreserved Stravix NPWT and lyopreserved Stravix: Subjects will be treated with NPWT and lyopreserved Stravix	Cryopreserved Stravix n=19 Participants Treated with NPWT and cryopreserved Stravix NPWT and cryopreserved Stravix: Subjects will be treated with NPWT and lyopreserved Stravix
Duration of Negative Pressure Wound Therapy	8.88 days Standard Deviation 5.96	4.66 days Standard Deviation 2.73

SECONDARY outcome

Timeframe: 12 weeks

Number of patients who received a split thickness skin graft

Outcome measures

Measure	Lyopreserved Stravix n=21 Participants Treated with NPWT and lyopreserved Stravix NPWT and lyopreserved Stravix: Subjects will be treated with NPWT and lyopreserved Stravix	Cryopreserved Stravix n=19 Participants Treated with NPWT and cryopreserved Stravix NPWT and cryopreserved Stravix: Subjects will be treated with NPWT and lyopreserved Stravix
Split Thickness Skin Grafting	2 Participants	3 Participants

SECONDARY outcome

Timeframe: 12 weeks

Number of patients who developed infection

Outcome measures

Measure	Lyopreserved Stravix n=21 Participants Treated with NPWT and lyopreserved Stravix NPWT and lyopreserved Stravix: Subjects will be treated with NPWT and lyopreserved Stravix	Cryopreserved Stravix n=19 Participants Treated with NPWT and cryopreserved Stravix NPWT and cryopreserved Stravix: Subjects will be treated with NPWT and lyopreserved Stravix
Infection	1 Participants	2 Participants

Adverse Events

Lyopreserved Stravix

Serious events: 3 serious events

Other events: 1 other events

Deaths: 0 deaths

Cryopreserved Stravix

Serious events: 2 serious events

Other events: 2 other events

Deaths: 1 deaths

Serious adverse events

Measure	Lyopreserved Stravix n=21 participants at risk Treated with NPWT and lyopreserved Stravix NPWT and lyopreserved Stravix: Subjects will be treated with NPWT and lyopreserved Stravix	Cryopreserved Stravix n=19 participants at risk Treated with NPWT and cryopreserved Stravix NPWT and cryopreserved Stravix: Subjects will be treated with NPWT and lyopreserved Stravix
Skin and subcutaneous tissue disorders Hospital admission for foot infection	4.8% 1/21 • Number of events 1 • 12 weeks	0.00% 0/19 • 12 weeks
General disorders Hospital admission for non-foot reason	9.5% 2/21 • Number of events 2 • 12 weeks	10.5% 2/19 • Number of events 2 • 12 weeks

Other adverse events

Measure	Lyopreserved Stravix n=21 participants at risk Treated with NPWT and lyopreserved Stravix NPWT and lyopreserved Stravix: Subjects will be treated with NPWT and lyopreserved Stravix	Cryopreserved Stravix n=19 participants at risk Treated with NPWT and cryopreserved Stravix NPWT and cryopreserved Stravix: Subjects will be treated with NPWT and lyopreserved Stravix
Skin and subcutaneous tissue disorders Infection of study wound	4.8% 1/21 • Number of events 1 • 12 weeks	10.5% 2/19 • Number of events 2 • 12 weeks

Additional Information

Tara Kristof - research coordinator

University of Texas Southwestern Medical Center

Phone: 214-648-9007

Email: tara.kristof@utsouthwestern.edu

Results disclosure agreements

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