The Effect of Draping on Swelling in Shoulder Arthroscopy

Study Overview
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Brief Summary
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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.

Detailed Description
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Fluid extravasation into the surrounding tissue is common in shoulder arthroscopy. It frequently leads to soft tissue swelling and edema which results in poor visualization and prolonged surgical time. While usually resolves uneventfully within 12 hours, excessive fluid extravasation into the soft tissue around the shoulder may lead to serious consequences and complications such as airway compromise, tracheal deviation, neuropraxias, habdomyoloysis and skin necrosis have been reported in the literature. Methods aimed at reducing soft tissue swelling during shoulder arthroscopy in order to avoid complications (e.g., low pump pressure, short arthroscopic time) are routinely practiced. Nevertheless, fluid extravasation and soft tissue swelling remains a concern in shoulder arthroscopy. The purpose of the current study is to evaluate whether applying local compression to the shoulder by preoperative compressive draping will reduce soft tissue swelling during shoulder arthroscopy. To the investigators' knowledge, no previous study evaluated the influence of applying compressive draping to the shoulder on soft tissue swelling in shoulder arthroscopy.

Official Title
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Can Preoperative Compressive Draping Reduce Soft Tissue Swelling During Shoulder Arthroscopy? A Prospective Randomized Trial

Conditions
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Shoulder Arthroscopy, Soft Tissue Swelling

Intervention / Treatment
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* Device: Compressive draping using adhesive incise drape


Participation Criteria
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Eligibility Criteria
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Inclusion criteria for the study are defined as: 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. Exclusion criteria: Pregnant women. Arthroscopic procedure that was converted to an open (mini-open) surgery. Patients who do not meet the above mentioned inclusion criteria.

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: After signing an informed consent participants will be randomised to one of the two study groups.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard draping<br>Shoulder arthroscopy will be performed using standard draping with the shoulder exposed. | |
| Experimental: Compressive draping<br>After 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) | Device: Compressive draping using adhesive incise drape<br>* In the intervention group the shoulder will be drape with compressive draping using adhesive incise drape (Ioban™2 Antimicrobial Incise Drape, 3M Inc.,USA).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Shoulder Arthroscopy, Soft Tissue Swelling, Rotator Cuff Repair, Shoulder Arthroscopy Complications