NCT00665379

Comparative Trial in Compression Therapy in Leg Lymphedema

Prospective, Randomized Controlled Trial Comparing the Effect of 3M Coban 2 Layer Compression System Versus Trico Bandages in the Treatment of Leg Lymphedema.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Nij Smellinghe Hosptial · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this trial is to study the effect of the 3M Coban 2 Layer Compression System (hereafter C2L) in the treatment of leg lymphedema compared to the traditional treatment with Trico bandages.

Detailed description

The goal of this prospective, randomized, controlled trial with CE marked product is to study the effectiveness (volume reduction) of 24-hour compression therapy for lymphedema, comparing C2L and Trico bandaging. Therefore 30 patients with leg lymphedema are included. Application of marketed compression bandages (C2L or Trico bandages) used for treatment by trained specialists with assessment of the subbandage pressure and volume reduction. Measurements are carried out at: Volumetry: Measurements after 0h, 2h and 24 h by using classic water displacement apparatus. Pressure: Measurements after 0h, 2h (pre and post bandage change) and 24 h; * supine and standing to calculate the SSI; * supine with and without dorsal flexion. for the pressure measurement a Kikuhime (large pads) dice is used. At each new bandaging to document the SSI and the effect of dorsiflexion in the supine position * The subbandage pressure is measured on the medial aspect of the lower leg at the transition of the gastrocnemius muscle into the Achilles' tendon (B1) (Partsch H. et al. Dermatol Surg 2006; 32: 224-233). * Fix the sensor (sensor and tube sheathed with Cellona Soft Padding) Statistical analysis; Analysis of variance (ANOVA) comparing volume, supine subbandage pressure with and without dorsiflexion, and SSI for the used bandages

Conditions

• Leg Lymphedema

Interventions

Type	Name	Description
OTHER	Regular Compression therapy (Trico bandages)	Application of marketed Trico compression bandages used for treatment by trained specialists with assessment of the subbandage pressure and volume reduction. The bandages are applicated in patients with leg lymphedema at t=0 hour, t=2 hours. Comparison is made at t=2 hours, t= 24 hours
OTHER	New Compression therapy (C2L bandages)	Application of marketed compression bandages C2L used for treatment by trained specialists with assessment of the subbandage pressure and volume reduction. he bandages are applicated in patients with leg lymphedema at t=0 hour, t=2 hours. Comparison is made at t=2 hours, t= 24 hours

Timeline

• Start date: 2008-04-01
• Primary completion: 2009-04-01
• Completion: 2009-05-01
• First posted: 2008-04-23
• Last updated: 2012-05-22

Locations

1 site across 1 country: Netherlands