Feasibility Study of a Novel Device for Chronic Wounds

Wounds and Injuries Clinical Trial

Official title:

Feasibility Study of a Novel Device for Chronic Wounds

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00660049
• Other study ID #: SU-02252008-1026
• Secondary ID: IRB Protocol #:
• Status: Completed
• Phase: N/A
• First received: April 4, 2008
• Last updated: November 15, 2017
• Start date: March 2008
• Est. completion date: August 2010

Study information

• Verified date: November 2017
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the feasibility and usability of a new portable and compact wound dressing device for the treatment of small chronic skin wounds.

Description:

This is an open label study

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: August 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:- Venous stasis ulcer or other chronic wound on the lower extremity that is >1.5cm and <10cm at widest point

• The wound must have at least 2 cm of intact epithelium surrounding it.

• A wound such as a pressure ulcer or chronic ulcer on a location other than the lower extremity may also be included in the study if it meets the size requirements and a reliable seal can be achieved.

• Ulcer must not have healed for >14 days under standard treatment.

• Chronic wound with prior graft placement will be allowed in the study.

• Patient is >18 years old.

• Willing and able to sign informed consent.

Exclusion Criteria:- Active wound infection.

• 3+ or greater pitting edema of lower extremity

• History of malignancy at wound site. However, wounds that are closing by secondary intent after surgical clearance of prior tumor will be allowed in the study.

• Thick eschar at wound base after debridement.

• Wound location is not amenable to forming an airtight seal and placement of device.

• Ulcers due to inflammatory conditions such as pyoderma gangrenosum, rheumatoid arthritis, vasculitis, cryoglobulinemia, necrobiosis lipoidica diabeticorum, lupus or pancreatic panniculitis, cryofibrinogenemia, calcinosis cutis, scleroderma, Raynaud's syndrome.

• Current smoker (must have quit for >3 weeks)

• Wound with exposed bone, blood vessels, tendon

• Significant immunosuppression (as determined by the investigator and sponsor) such as high dose prednisone

• Fasting blood sugar >200 by study personnel administered bedside fingerstick blood glucose

• Ankle brachial index less than lower limit of normal (<0.60) as performed and determined by licensed physician (necessary only for patients with lower extremity wounds).

• Pregnancy

• Incapable of giving informed consent

• Inability to comply with study procedures including lack of telephone access for week 8 telephone survey

Related Conditions & MeSH terms

• Ulcer
• Wounds and Injuries

Intervention

Device:
• SNaP Advanced Wound Care System
Application of negative pressure device daily per instructions

Other:
• SNaP
Daily use
• SNaP
Daily application per protocol

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	Spiracur, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

Fong KD, Hu D, Eichstadt SL, Gorell E, Munoz CA, Lorenz HP, Chang AL. ??????Initial clinical experience using a novel ultraportable negative pressure wound therapy device. Wounds. 2010 Sep;22(9):230-6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ease of Use for Patients	Participants were given instructions to use the SNaP device home. Participants completed a questionnaire reporting whether the device was easy to use, worthwhile to use, and whether they would use the device again. Numbers responding positively to each question are presented.	Baseline up to 31 days