The Effect of Draping on Swelling in Shoulder Arthroscopy
Can Preoperative Compressive Draping Reduce Soft Tissue Swelling During Shoulder Arthroscopy? A Prospective Randomized Trial
1 other identifier
interventional
50
0 countries
N/A
Brief Summary
Strategies to minimize soft tissue swelling during shoulder arthroscopy are constantly sought after. The investigators propose an unfamiliar method which may reduce tissue swelling during shoulder arthroscopy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2017
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 9, 2017
CompletedFirst Posted
Study publicly available on registry
July 13, 2017
CompletedStudy Start
First participant enrolled
July 20, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 20, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 20, 2017
CompletedJuly 13, 2017
July 1, 2017
5 months
July 9, 2017
July 12, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change on shoulder circumference
The change in shoulder circumference will be assessed at the end of the procedure. Shoulder circumference before and at the end of the procedure will be measured from the mid-point between the coracoid process and anterior axillary fold anteriorly to the mid-point between the scapular spine and the posterior axillary fold posteriorly.
Immediate post-operative
Study Arms (2)
Standard draping
NO INTERVENTIONShoulder arthroscopy will be performed using standard draping with the shoulder exposed.
Compressive draping
EXPERIMENTALAfter standard preparation similar to the no-intervention group, the shoulder will be draped with compressive draping using adhesive incise drape (Ioban™2 Antimicrobial Incise Drape, 3M Inc.,USA)
Interventions
In the intervention group the shoulder will be drape with compressive draping using adhesive incise drape (Ioban™2 Antimicrobial Incise Drape, 3M Inc.,USA).
Eligibility Criteria
You may qualify if:
- Surgery indicated for chronic symptomatic RC tear unresponsive to non-operative treatment over a minimal period of 6 months.
- Small to medium size tears (\<3 cm).
- Age older than 18 years.
- ASA score 1or 2.
- Body mass index (BMI) \< 35.
- Willingness to provide an informed consent.
You may not qualify if:
- Pregnant women.
- Arthroscopic procedure that was converted to an open ("mini-open") surgery.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Uri O, Alfandari L, Yaron R, Kettanie A, Laufer G, Behrbalk E. Effect of Compressive Shoulder Draping With Adhesive Incise Drape on Soft Tissue Swelling in Shoulder Arthroscopy: A Prospective Randomized Trial. Orthop J Sports Med. 2024 Feb 19;12(2):23259671241229736. doi: 10.1177/23259671241229736. eCollection 2024 Feb.
PMID: 38379580DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Ofir Uri
Hillel Yaffe Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 9, 2017
First Posted
July 13, 2017
Study Start
July 20, 2017
Primary Completion
December 20, 2017
Study Completion
December 20, 2017
Last Updated
July 13, 2017
Record last verified: 2017-07