Vacuum-Assisted Dressings (V-AD) in the Management of Open Chest Wounds

Not Applicable

Completed

• Conditions: Open Chest Wounds
• Interventions: Other: Control group; Device: Wound Vacuum-assisted dressing

• Registration Number: NCT02803164
• Lead Sponsor: Mayo Clinic

Brief Summary

Vacuum-assisted dressings (V-AD) are effective in treating patients with open chest wounds (OCW) and will decrease the time-to-closure of such wounds when compared to a historical cohort of patients managed by traditional wound care management.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-06-14
• Study First Submitted QC: 2016-06-14
• Study First Posted: 2016-06-16
• Study Start: 2017-02-10
• Primary Completion: 2020-11-03
• Study Completion: 2020-11-03
• Status Verified: 2021-09
• Results First Submitted: 2021-09-07
• Results First Submitted QC: 2021-09-07
• Last Update Submitted: 2021-09-07
• Results First Posted: 2021-09-29
• Last Update Posted: 2021-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

• Subject is scheduled to undergo surgical intervention(s) as part of the standard care for management of intra-thoracic infection.

Exclusion Criteria

• Patent bronchopleural fistulas. Severe respiratory failure requiring mechanical ventilation at the time of first consultation.
• Proven or suspected malignancy in the wound. Coagulopathy due to medical or pharmacologic reasons. Dependency on anticoagulants or antiplatelet medication due to high risk for adverse events if these medications are stopped for a prolonged period of time.

Allergy to acrylic products.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Historical control group for comparison	Control group	Retrospective review of subjects medical records with open chest wounds who were treated with the traditional treatment techniques.
Vacuum-assisted dressing	Wound Vacuum-assisted dressing	Eligible subjects will receive negative pressure wound therapy during surgery.

Primary Outcome Measures

Name	Time	Method
Duration of Negative Pressure Wound Therapy (NWPT)	12 month follow up	The total number of days of receiving NWPT

Secondary Outcome Measures

Name	Time	Method
Length of Hospital Stay	12 months	The total number of days in hospital
Wound Closure	12 months	The total number of days to wound closure

Trial Locations

Locations (1)

Mauricia Buchanan; 🇺🇸 Jacksonville, Florida, United States