Simplified Negative Pressure Wound Therapy

Wounds Clinical Trial

Official title:

Evaluation of the Performance and Safety of a Simplified Negative Pressure Wound Therapy Device

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01339429
• Other study ID #: 2010-P-002279/1
• Status: Completed
• Phase: Phase 1
• First received: March 28, 2011
• Last updated: May 19, 2015
• Start date: March 2011
• Est. completion date: February 2012

Study information

• Verified date: May 2015
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Partners Human Research Committee Institutional Review BoardRwanda: Rwandan National Ethics Committee and Central University Teaching Hospital in Kigali Institutional Review BoardUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 14 Years to 90 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Wounds

Intervention

Device:
• simplified negative pressure wound therapy device (Wound Pump device)
A non-powered negative pressure device utilizing a bellows attached to a specialized dressing via drainage tube to promote healing of open wounds.

Locations

Country	Name	City	State
Rwanda	Central University Teaching Hospital in Kigali	Kigali
Rwanda	Rwinkwavu Hospital	Rwinkwavu	Kayonza District

Sponsors (3)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	Center for Integration of Medicine & Innovative Technology, Fogarty International Clinical Research Scholarship

Country where clinical trial is conducted

Rwanda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Number of Participants With Serious Adverse Events	Any adverse events, including bleeding, wound complication, or change in patient condition during the trial period will be recorded.	3 days	Yes