NCT01339429

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Mar 2011

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

March 28, 2011

Completed
23 days until next milestone

First Posted

Study publicly available on registry

April 20, 2011

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
3.3 years until next milestone

Results Posted

Study results publicly available

May 20, 2015

Completed
Last Updated

May 20, 2015

Status Verified

May 1, 2015

Enrollment Period

11 months

First QC Date

March 28, 2011

Results QC Date

February 12, 2014

Last Update Submit

May 19, 2015

Conditions

Wounds

Keywords

woundnegative pressure wound therapynon-powered negative pressure wound therapy

Outcome Measures

Primary Outcomes (1)

  • Maintenance of Negative Pressure

    The negative pressure being delivered by the device was measured on a daily basis for three days. Maintenance of negative pressure was defined as negative pressure delivery within 75% of the starting negative pressure amount.

    3 days

Secondary Outcomes (1)

  • Number of Participants With Serious Adverse Events

    3 days

Study Arms (1)

simplified Negative Pressure Wound Therapy

EXPERIMENTAL

The simplified Negative Pressure device will be placed on subjects selected from the hospital ward and meeting the eligibility criteria.

Device: simplified negative pressure wound therapy device (Wound Pump device)

Interventions

simplified negative pressure wound therapy device (Wound Pump device)DEVICE

A non-powered negative pressure device utilizing a bellows attached to a specialized dressing via drainage tube to promote healing of open wounds.

Also known as: Wound Pump, manufactured by Worldwide Innovative Healthcare, Inc.
simplified Negative Pressure Wound Therapy

Eligibility Criteria

Age14 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Rwinkwavu Hospital

Rwinkwavu, Kayonza District, Rwanda

Location

Central University Teaching Hospital in Kigali

Kigali, Kigali, Rwanda

Location

Related Publications (1)

  • Mody GN, Zurovcik DR, Joharifard S, Kansayisa G, Uwimana G, Baganizi E, Ntakiyiruta G, Mugenzi D, Riviello R. Biomechanical and safety testing of a simplified negative-pressure wound therapy device. Plast Reconstr Surg. 2015 Apr;135(4):1140-1146. doi: 10.1097/PRS.0000000000001101.

    PMID: 25502858DERIVED

MeSH Terms

Conditions

Wounds and Injuries

Results Point of Contact

Title
Dr. Gita Mody
Organization
Brigham and Women's Hospital
gmody@partners.org
617-921-8221

Study Officials

  • Robert Riviello, M.D., M.P.H.

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Instructor in Surgery

Study Record Dates

First Submitted

March 28, 2011

First Posted

April 20, 2011

Study Start

March 1, 2011

Primary Completion

February 1, 2012

Study Completion

February 1, 2012

Last Updated

May 20, 2015

Results First Posted

May 20, 2015

Record last verified: 2015-05

Locations

RW(2)