COMPARISON OF BANDAGE IN HAND EDEMA

NCT06938048 | Enrolling By Invitation

• 1 other identifier: 280CET
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this clinical trial is to compare the effectiveness of high and short stretch bandages in hand edema treatment of adult patients with affected hand volume superior of at least 5% compared to the contralateral hand. The main question to be answered by this study is: which bandage is more effective in reducing edema? Endpoint 1: hand volume, measured by immersion volumetry (Valgrado method). Endpoint 2: ROM (range of motion) of the fingers and wrist, measured by goniometry. Endpoint 3: Results of a semi-structured interview on participants subjective perception of hand function and esthetics, ADL performance and quality of life. This study includes 2 groups (arms); each participantreceives both types of bandages but in a different temporal order depending on group membership:

• Arm A: short stretch bandage applied as the first treatment.
• Arm B: high stretch bandage applied as first treatment. Patients will be randomized 1:1 using the RedCap Software. The entire study will take place over 3 consecutive days. On each of these days, participants are examined (hand volume, finger and wrist ROM), receive the bandage (the type of bandage depends on the participant group), undergo physiotherapy treatment and then practice specific hand mobilization exercises at home. At the end of the study, the data on hand volume and mobility of the hand and wrist will be analyzed to determine which type of bandage, high-stretch or low-stretch one, is most effective in reducing hand volume (and therefore hand edema) and mobility of the hand and wrist. In addition, data collected using the semi-structured interview will be analyzed to examine patients subjective perceptions of hand function and esthetics, ADL performance and quality of life.

Conditions

Edema

Keywords

bandages; edema; hand

Outcome Measures

Primary Outcomes (1)

• Hand volume

  Hand volume will be measured using immersion volumetry, according to the Valgrado method.

  Hand volume will be measured 3 times, from enrollment to 48 hours after: T0 (first assessment), T1 (24 hours after first bandage application), T2 (24 hours after second bandage application).

Secondary Outcomes (2)

• Range Of Motion (ROM)

  Wrist and fingers ROM will be measured 3 times, from enrollment to 48 hours after: T0 (first assessment), T1 (24 hours after first bandage application), T2 (24 hours after second bandage application).

• Semi-structured interview

  Results from the semi-structured interview will be collected 2 times, from enrollment to 48 hours after: T1 (24 hours after first bandage application), T2 (24 hours after second bandage application).

Study Arms (2)

Arm "Short First"

EXPERIMENTAL

Short stretch bandage applied in the first 24 hours

Other: short stretch bendage (Lohmann e Raucher); Other: high stretch bandage (Coban)

Arm "High first"

ACTIVE COMPARATOR

High stretch bandage applied in the first 24 hours

Other: short stretch bendage (Lohmann e Raucher); Other: high stretch bandage (Coban)

Interventions

short stretch bendage (Lohmann e Raucher) OTHER

extensibility between 10% to 100% of the lenght

Arm "High first"; Arm "Short First"

high stretch bandage (Coban) OTHER

extensibility above 100% of the lenght

Arm "High first"; Arm "Short First"

Eligibility Criteria

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

You may not qualify if:

• Presence of hand edema, with the affected hand showing a volume at least 5% greater than the contralateral hand. Hand volume is measured using the Valgrado immersion volumetry method.
• Edema of the following etiologies:
• Traumatic (injury to the hand or upper limb resulting in edema of the hand or fingers)
• Surgical
• Algodystrophic
• Rheumatologic
• Secondary to immobility
• Lacerations or cut injuries to the forearm, due to the potential compromise of lymphatic drainage pathways from the hand.
• Pathologies involving the peripheral nervous system of the upper limb (e.g., nerve injuries with resulting paralysis).
• Contraindications to active mobilization of the wrist and finger joints (metacarpophalangeal and interphalangeal joints).

Sponsors & Collaborators

• Regione del Veneto - AULSS n. 7 Pedemontana: lead

Study Sites (1)

ULSS 7 Pedemontana

Bassano, Italy, Italy

Location

MeSH Terms

Conditions

Edema

Interventions

Monensin

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Polyether Polyketides; Ethers, Cyclic; Ethers; Organic Chemicals; Polyketides; Lactones; Furans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Macrocyclic Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor, specialized in Physical Medicine and Rehabilitation, head of Hub Lymphedema Center AULSS 7 Pedemontana

Study Record Dates

• First Submitted: January 7, 2025
• First Posted: April 22, 2025
• Study Start: September 6, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 22, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)