Phase 1 N=41 Treatment

Simplified Negative Pressure Wound Therapy

Wounds

Bottom Line

View on ClinicalTrials.gov: NCT01339429 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2015

Primary outcome: Primary: Maintenance of Negative Pressure — 22.2 hours

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: simplified negative pressure wound therapy device (Wound Pump device) (Device)
Age: Pediatric, Adult, Older Adult · 14+ yrs
Sex: All
Sponsor: Brigham and Women's Hospital
Primary completion: Feb 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Maintenance of Negative Pressure	22.2	—
SECONDARY Number of Participants With Serious Adverse Events	—	—

Summary

The objective of this study is to implement a simplified Negative Pressure Wound Therapy (sNPWT) device in a low resource setting. The investigators hypothesize that the sNPWT device is at least equivalent to commercially available NPWT devices. Therefore, the specific aims of this study will be to measure: 1. the mechanical properties of the sNPWT device and 2. the adverse events associated with the sNPWT device.

Eligibility Criteria

Inclusion Criteria

open wound appropriate for NPWT
wound size greater than 2 cm2 and less than 150 cm2
adequate adjacent intact skin for application of sNPWT
adequate contour of wound location for application of sNPWT
patient is expected to tolerate change of the NPWT dressing with the chosen analgesia and sedation plan by the treating physician
the patient is expected to remain clinically stable for the duration of the study
the patient is to remain hospitalized for the duration of the study
patient or their legal representative is willing and able to sign an IRB-approved informed consent
patient less than 21 years old is willing to sign an approved assent form if able to sign

Exclusion Criteria

exposed blood vessels
ischemic wound
wound with necrotic tissue requiring further debridement at the time of enrollment
infection
acute osteomyelitis
malignancy in the wound
latex or rubber containing product sensitivity

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01339429). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.