Effects of Shrinker Use on Healing and Volume

Study Overview
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Brief Summary
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We expect subjects in the interventional groups, who wear shrinkers, to heal more quickly than control subjects who wear no shrinkers. We also expect them to experience greater reduction in residual limb volume during the early stages of postoperative care leading up to prosthetic fitting, fewer healing complications, reduced time to the prosthetic fitting, increased time to the first prosthetic socket replacement, and fewer socket replacements by the end of the transition to stable phase.

Detailed Description
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Edema is an inevitable result of amputation surgery. Persistent edema can affect oxygen and nutrient flow into, as well as waste flow out of the residual limb. Shrinkers are a common and effective treatment for edema. However, their influence on healing and long term limb volume has not been studied. This study will pertain to human subjects affected by primary transtibial amputation. Two interventional groups of patients will use shrinkers with different levels of compression as part of their rehabilitation. A third, control group will not use shrinkers. The groups will be studied to determine the effects of shrinker use on healing and long term residual limb volume.

Official Title
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Effects of Shrinker Use on Healing and Volume for Transtibial Amputees

Conditions
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Transtibial Amputation

Intervention / Treatment
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* Device: compression shrinker


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Recently undergone primary transtibial amputation Patients between ages of 18 and 100 years of age Exclusion Criteria: Undergone previous amputations above the Symes level

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Shrinker<br>Patients receive 20-30 mmHg compression shrinker, an elastic compression garment that is worn on the residual limb and is used to reduce edema and promote healing. | Device: compression shrinker<br>* Two levels of compression: 20-30 mmHg or 30-40 mmHg shrinker<br>* Other names: Juzo® Compression Therapy Garment;|
| No Intervention: No Shrinker<br>Control group - participants will not receive an intervention (compression shrinker). | |
| Active Comparator: Shrinker 2<br>Patients receive 30-40 mmHg compression shrinker, an elastic compression garment that is worn on the residual limb and is used to reduce edema and promote healing. | Device: compression shrinker<br>* Two levels of compression: 20-30 mmHg or 30-40 mmHg shrinker<br>* Other names: Juzo® Compression Therapy Garment;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in Time to Healing | time to healing in each group | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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volume, healing, shrinker, transtibial amputation, individuals who have undergone transtibial amputation