Effectiveness of a Pressure Indicator Guided and a Conventional Bandaging in Treatment of Venous Leg Ulcer

NCT02729688 | Completed

• 1 other identifier: SIRIRAJ016/2559
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Objective of this study are to compare the interface pressure by applying ordinary elastic bandage (OEB) and CPG-EB. In addition, investigators compared the percentage of patients who could apply the optimal pressure with OEB and CPG-EB.

Conditions

Venous Insufficiency

Keywords

Venous insufficiency; Compression; Bandaging

Outcome Measures

Primary Outcomes (1)

• Sub-bandage pressure

  1 hour

Study Arms (2)

ordinary elastic bandage

ACTIVE COMPARATOR

Bandaging was applied by spiral methods. Three ordinary elastic bandages were applied with 50 % stretching and 50% overlapping from foot to just below knee level.

Device: Ordinary elastic bandage

customized pressure guide bandage

ACTIVE COMPARATOR

Bandaging was applied by spiral methods. Three customized pressure guide elastic bandage were applied by stretching until the elliptical shape marker in the bandage turned into circular shape with 50% overlapping from foot to just below knee level.

Device: customized pressure guide bandage

Interventions

customized pressure guide bandage DEVICE

Investigators developed the customized pressure guide elastic bandage (CPG-EB). The experienced nurse applied the elastic bandages to each patient with sub bandage pressure monitoring. The target pressure was 35-45 mmHg. Measurements of the pressure applied by bandages was performed at point B1 corresponding to the height where the Achilles' tendon turns into the gastrocnemius muscle with Picopress (MicroLAB Elettronica, Ponte S. Nicolo, Italy). If the target pressure 35-45 mmHg was achieved, the circular ink stamp was applied into the entire bandages. The markers in CPG-EB had elliptical shape when they were not stretched. They turned into circular shape when they were stretched. For the OEB, Bandaging was applied by spiral methods. Three EB were applied with 50 % stretching and 50% overlapping from foot to just below knee level.

customized pressure guide bandage

Ordinary elastic bandage DEVICE

Bandaging was applied by spiral methods. Three ordinary elastic bandages were applied with 50 % stretching and 50% overlapping from foot to just below knee level.

ordinary elastic bandage

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with chronic venous insufficiency CEAP (clinical, etiologic, anatomic, and pathophysiologic) C4,C5 and C6

You may not qualify if:

• Patients who can not perform bandaging by themselves

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Vascular Surgery, Siriraj Hospital, Mahidol University

Bangkoknoi, Bangkok, 10700, Thailand

Location

Related Publications (1)

• Sermsathanasawadi N, Tarapongpun T, Pianchareonsin R, Puangpunngam N, Wongwanit C, Chinsakchai K, Mutirangura P, Ruangsetakit C. Customizing elastic pressure bandages for reuse to a predetermined, sub-bandage pressure: A randomized controlled trial. Phlebology. 2018 Oct;33(9):627-635. doi: 10.1177/0268355517746434. Epub 2017 Dec 25.

  PMID: 29277134 DERIVED

MeSH Terms

Conditions

Venous Insufficiency

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Nuttawut Sermsathanasawadi, MD

  Mahidol University

  PRINCIPAL INVESTIGATOR

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: March 25, 2016
• First Posted: April 6, 2016
• Study Start: March 1, 2016
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: August 17, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)