Trial Outcomes & Findings for Evaluating the Ease of Use of a VAC GranuFoam Bridge Dressing on Diabetic Foot Ulcers Receiving VAC Negative Pressure Wound Therapy (NCT NCT00847730)

Last Updated: 2024-10-16

Results Overview

Each subject was assessed on the three scales (each scale was 1-Poor, 2 - Fair, 3 - Good, 4 - Excellent) and given a score on each individual characteristic (Ease of Dressing Application, Ease of Conformability, and Ease of Dressing Removal). The scores were then summed for each subject with possible range being 3-12. If the subject had a total score greater than or equal to 6, and a minimum score of greater than or equal to 2 on each individual characteristic then the subject was included in the percentage of subjects with satisfactory performance. Note that for each scale higher scores indicate better outcomes.

Recruitment status

COMPLETED

Study phase

Target enrollment

33 participants

Primary outcome timeframe

48-72 hours (+6 hours) time period

Results posted on

2024-10-16

Participant Flow

Participant milestones

Participant milestones
Measure	V.A.C Bridge Dressing This is a medical device foam dressing allowing placement away from wound site. It is designed to simplify the bridging application. It is used in combination with the V.A.C. Negative Pressure Wound Therapy System. For each subject, the dressing was applied in compliance with the IFU for 48-72 hours.
Overall Study STARTED	33
Overall Study COMPLETED	25
Overall Study NOT COMPLETED	8

Reasons for withdrawal

Reasons for withdrawal
Measure	V.A.C Bridge Dressing This is a medical device foam dressing allowing placement away from wound site. It is designed to simplify the bridging application. It is used in combination with the V.A.C. Negative Pressure Wound Therapy System. For each subject, the dressing was applied in compliance with the IFU for 48-72 hours.
Overall Study Multiple interruptions in therapy	8

Baseline Characteristics

Evaluating the Ease of Use of a VAC GranuFoam Bridge Dressing on Diabetic Foot Ulcers Receiving VAC Negative Pressure Wound Therapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	V.A.C Bridge Dressing n=33 Participants This is a medical device foam dressing allowing placement away from wound site. It is designed to simplify the bridging application. It is used in combination with the V.A.C. Negative Pressure Wound Therapy System. For each subject, the dressing was applied in compliance with the IFU for 48-72 hours.
Age, Continuous	57.2 years STANDARD_DEVIATION 13.32 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants
Sex: Female, Male Male	24 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	1 Participants n=5 Participants
Race/Ethnicity, Customized White	19 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino	12 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaskan Native	1 Participants n=5 Participants
Region of Enrollment United States	33 participants n=5 Participants

PRIMARY outcome

Timeframe: 48-72 hours (+6 hours) time period

Population: ITT (Intent to Treat) population.

Outcome measures

Outcome measures
Measure	VAC GranuFoam Bridge Dressing n=30 Participants This is a medical device foam dressing allowing placement away from wound site. It is designed to simplify the bridging application. It is used in combination with the V.A.C. Negative Pressure Wound Therapy System. For each subject, the dressing was applied in compliance with the IFU for 48-72 hours.
Ease of Use Assessment Ease of Dressing Application · 1-Poor	0 Participants
Ease of Use Assessment Ease of Dressing Application · 2-Fair	3 Participants
Ease of Use Assessment Ease of Dressing Application · 3-Good	14 Participants
Ease of Use Assessment Ease of Dressing Application · 4-Excellent	13 Participants
Ease of Use Assessment Ease of Comfortability · 1-Poor	0 Participants
Ease of Use Assessment Ease of Comfortability · 2-Fair	1 Participants
Ease of Use Assessment Ease of Comfortability · 3-Good	9 Participants
Ease of Use Assessment Ease of Comfortability · 4-Excellent	20 Participants
Ease of Use Assessment Ease of Dressing Removal · 1-Poor	0 Participants
Ease of Use Assessment Ease of Dressing Removal · 2-Fair	1 Participants
Ease of Use Assessment Ease of Dressing Removal · 3-Good	4 Participants
Ease of Use Assessment Ease of Dressing Removal · 4-Excellent	25 Participants

Adverse Events

VAC GranuFoam Bridge Dressing

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	VAC GranuFoam Bridge Dressing n=33 participants at risk This is a medical device foam dressing allowing placement away from wound site. It is designed to simplify the bridging application. It is used in combination with the V.A.C. Negative Pressure Wound Therapy System. For each subject, the dressing was applied in compliance with the IFU for 48-72 hours.
Skin and subcutaneous tissue disorders Skin Maceration	24.2% 8/33 • 1 week Adverse Events were assessed at each protocol scheduled visit.

Additional Information

VP, Global Clinical Affairs

KCI

Phone: 2102555595

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place