N/A
N=12
Effect of Pneumatic Tourniquet on Arm Swelling After Lymph Node Removal
Healthy Subject
Bottom Line
View on ClinicalTrials.gov: NCT03584100 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Jun 2021
Primary outcome: Primary: Change in Hand Volume Following Tourniquet Use — 15.0; 12.1; 12.5; 7.9 mL
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Tourniquet 8000 (Device)
- Age
- Adult, Older Adult · 19+ yrs
- Sex
- All
- Sponsor
- Stanford University
- Primary completion
- Jun 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Hand Volume Following Tourniquet Use |
15.0; 12.1; 12.5; 7.9 | — |
| SECONDARY Difference in Hand Volume Following Tourniquet Use, Between ALND and Control Limbs |
2.9; 4.6 | — |
Summary
The purpose of the proposed study is to evaluate the acute impact of swelling caused by low-pressure tourniquet use in the setting of ipsilateral prior axillary lymph node dissection and the change in swelling reduction following tourniquet use in three limb postures versus healthy volunteers.
Eligibility Criteria
Inclusion Criteria
- Have previously undergone axillary lymph node dissection
- Or healthy volunteers
Exclusion Criteria
- Have new-onset lymphedema of the involved limb.
- Infection including cellulitis
- Trauma or planned axillary surgery within 6 months of participation
- Any prior axillary radiation
Data sourced from ClinicalTrials.gov (NCT03584100). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.