The Study of Wound Dressings for Portable NPWT

Diabetic Foot Ulcer Clinical Trial

— NPWT  

Official title:

The Study of Wound Dressings for Portable Negative Pressure Wound Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03135964
• Other study ID #: 990903
• Status: Completed
• Phase: N/A
• First received: November 4, 2015
• Last updated: April 26, 2017
• Start date: February 2011
• Est. completion date: March 2016

Study information

• Verified date: April 2017
• Source: Tainan Municipal Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Introduction Negative pressure wound therapy (NPWT), also known as topical negative pressure, has become a popular therapy for the treatment of many acute and chronic wounds. In many randomized controlled trials(RCTs), NPWT also has benefit in diabetic foot ulcer and pressure ulcer. However, most studies used commercial VAC device in combined with polyurethane (PU) foam. It is not yet clear where NPWT combined with gauze as wound filler is as effective as the PU foam. This RCT evaluated the efficacy of the gauze and PU foam, two kinds of fillers routinely used in negative pressure wound therapy, on the healing of the diabetic lower-extremity ulcers and the pressure ulcer.

Methods From 2010/1 to 2015/01, the in-patient persons with difficult to heal diabetic ulcer or Grade 4 pressure ulcer were enrolled. These patients were divided into two groups randomly. The letter of consent was signed by the patient or patient's family. After debridement of the infective wound, the wound of experimental group was packed with a moistened Polyhexamethylene biguamide (PHMB) impregnated gauze (Kerlix AMD, Covidien). A noncollapsible drainage tube (Blake drain, Ethicon) was applied to the wound, and then sealed with 3M Tegaderm Film. The system was connected to a 1-bottle water-seal chest drainage system and to standard wall suction at 125 mmHg negative pressure. The dressing was changed at 72- to 96-hour intervals (twice a week) for a period of 3 weeks. To the control group, the PU foam dressing from KCI was packed and sealed to the wound with the same continuous wall suction at -125mmHg. Investigators observed and recorded the ulcer area twice a week on each time of changing dressing in the following 3 weeks. The percentage of wound area reduction(PWAR) was used as a predictor of wound healing. The repeated measuring data were analyzed using linear mixed mode with SPSS statistical software. This clinical study was approved and monitored by Institutional Review Board of Show Chwan Memorial Hospital.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: March 2016
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• in-patient persons with the pressure ulcer or diabetic ulcer

Exclusion Criteria:

• Patient who has uncontrolled medical condition, such as sepsis, cellulitis

• Patient with diabetic ulcer who has severe PAOD untreated

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Ulcer
• Foot Ulcer
• Pressure Ulcer
• Ulcer

Intervention

Device:
• filler dressing of NPWT
a dressing or filler material is used to fit to the contours of a wound (which is covered with a non-adherent dressing film) .

Locations

Country	Name	City	State
Taiwan	Tainan Municipal Hospital	Tainan

Sponsors (1)

Lead Sponsor	Collaborator
Tainan Municipal Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The reduction rate of pressure ulcer size		up to 3weeks
Secondary	The reduction rate of diabetic foot ulcer size		up to 3weeks