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

NCT ID: NCT02729688

Last Updated: 2018-08-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2017-03-01

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.

Detailed Description

For treatment of venous ulcer, it was shown that compression bandaging of 35-45 mmHg sub-bandage pressure at the ankle was shown in several studies to be safe and effective.The efficacy of compression bandage considerably depends on the applied pressure and it is therefore largely dependent on the individual applying bandages. The lower pressure leads to treatment failure while the higher pressure leads to skin complication.

The use of objective devices to proof that the bandage is sufficiently applied is not available for every patients. To help the patients to apply the bandage with optimal pressure, investigators developed the customized pressure guide elastic bandage (CPG-EB) by using sub-bandage pressure guidance.

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 inexperienced staffs who could apply the optimal pressure with OEB and CPG-EB.

Conditions

Venous Insufficiency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ordinary elastic bandage

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.

Group Type: ACTIVE_COMPARATOR

Ordinary elastic bandage

Intervention Type: 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.

customized pressure guide bandage

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.

Group Type: ACTIVE_COMPARATOR

customized pressure guide bandage

Intervention Type: 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.

Interventions

customized pressure guide bandage

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.

Intervention Type: DEVICE

Ordinary elastic bandage

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Patients who can not perform bandaging by themselves

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mahidol University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nuttawut Sermsathanasawadi, MD

Role: PRINCIPAL_INVESTIGATOR

Mahidol University

Locations

Vascular Surgery, Siriraj Hospital, Mahidol University

Bangkoknoi, Bangkok, Thailand

Countries

Thailand

References

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.

Reference Type: DERIVED

PMID: 29277134 (View on PubMed)

Other Identifiers

SIRIRAJ016/2559

Identifier Type: -

Identifier Source: org_study_id