The Study of Wound Dressings for Portable NPWT

NCT03135964 | Completed

• 1 other identifier: 990903
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pressure Ulcer; Diabetic Foot Ulcer

Keywords

NPWT; foam; gauze

Outcome Measures

Primary Outcomes (1)

• The reduction rate of pressure ulcer size

  up to 3weeks

Secondary Outcomes (1)

• The reduction rate of diabetic foot ulcer size

  up to 3weeks

Study Arms (2)

foam

ACTIVE COMPARATOR

PU foam dressing from KCI

Device: filler dressing of NPWT

gauze

ACTIVE COMPARATOR

Polyhexamethylene biguamide (PHMB) impregnated gauze (Kerlix AMD, Covidien)

Device: filler dressing of NPWT

Interventions

filler dressing of NPWT DEVICE

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

Also known as: KCI PU foam dressing, Kerlix AMD gauze

foam; gauze

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patient who has uncontrolled medical condition, such as sepsis, cellulitis
• Patient with diabetic ulcer who has severe PAOD untreated

Sponsors & Collaborators

• Tainan Municipal Hospital: lead

Study Sites (1)

Tainan Municipal Hospital

Tainan, 701, Taiwan

Location

MeSH Terms

Conditions

Pressure Ulcer; Diabetic Foot

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Study Officials

• Chao-Chin Yu, Master

  Tainan Municipal Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2015
• First Posted: May 2, 2017
• Study Start: February 1, 2011
• Primary Completion: January 1, 2015
• Study Completion: March 1, 2016
• Last Updated: May 2, 2017

Record last verified: 2017-04

Locations

TW (1)