Effects of Shrinker Use on Healing and Volume

University of Oklahoma (OU)

Status: Terminated

Conditions: Transtibial Amputation

Treatments: Device: compression shrinker

Study type: Interventional

Funder types: Other

Identifiers

NCT00693628

13310 (Other Identifier)

Details and patient eligibility

About

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".

Full description

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.

Enrollment: 4 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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4 participants in 3 patient groups

Shrinker

Active Comparator group

Description:

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.

Treatment:

Device: compression shrinker

No Shrinker

No Intervention group

Description:

Control group - participants will not receive an intervention (compression shrinker).

Shrinker 2

Active Comparator group

Description:

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.

Treatment:

Device: compression shrinker