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Randomized controlled trial compares clinical outcome between Negative pressure wound therapy(NPWT) with CBH-KMITL Ambulatory Negative Pressuring Device (CKANPD) and conventional device in Open traumatic wound

Randomized controlled trial compares clinical outcome between Negative pressure wound therapy(NPWT) with CBH-KMITL Ambulatory Negative Pressuring Device (CKANPD) and conventional device in Open traumatic wound

Status
Unknown
Phases
Phase 2Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20230621008
Enrollment
60
Registered
2023-06-21
Start date
2022-12-01
Completion date
Unknown
Last updated
2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Open traumatic wound Soft tissue defect Negative pressure wound therapy Vacuum dressing Open fracture Negative-Pressure Wound Therapy Wound Healing Wounds and Injuries Orthopedics Ambulatory Care Facilities Granulation Tissue Therapeutic Equivalency Surgical Procedures, Operative Soft Tissue Injuries Skin Transplantation Wound Closure Techniques Joint Injuries Debridement Age Factors Bone Exposure Tendon Injuries Ligaments, Articular - injuries Dead Space Wounds, Penetrating Ambulatory Ca

Interventions

CBH-KMITL Ambulatory Negative Pressuring Device (CKANPD) is an innovative, portable Negative Pressure Wound Therapy (NPWT) device designed and developed collaboratively by the Department of Orthopedic
s Institute of Technology Ladkrabang. The device&#039
s central premise lies in its portability, a feature anticipated to significantly alleviate the constraints of bed rest and prolonged hospital stays for patients. It aims to facilitate outpatient mana
s primary outcome measure is the percentage of wound granulation. This study is particularly significant considering the high cost of existing NPWT devices and their impact on healthcare budgeting, es
Negative Pressure Wound Therapy (NPWT) with CBH-KMITL Ambulatory Negative Pressuring Device (CKANPD) ,Negative Pressure Wound Therapy (NPWT) with conventional device

Sponsors

Researcher Private fund
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Patient with Open traumatic wound that after receive surgical management , soft tissue cover is not immediately possible13 Patient with wounds that require dead space management Patient with Exposed bone with degloved skin , tendons and ligaments Patient Open joint injuries with soft tissue loss Age 18-60 years

Exclusion criteria

Exclusion criteria: Contraindication for VAC therapy Presence of necrotic skin with eschar Untreated osteomyelitis Exposed neurovascular bundle Exposed vascular anastomosis

Design outcomes

Primary

MeasureTime frame
Percentage of granulation 7 day Percent / Image processing with ImageJ

Secondary

MeasureTime frame
Infection rate 7 day Clinical combine with laboratory investigation

Countries

Thailand

Contacts

Public ContactChayut Krualamai

Chonburi Hospital

chayut.kru@outlook.com0877480909

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Apr 4, 2026