The Effect of Draping on Swelling in Shoulder Arthroscopy

Not Applicable

• Conditions: Soft Tissue Swelling; Shoulder Arthroscopy
• Interventions: Device: Compressive draping using adhesive incise drape

• Registration Number: NCT03216590
• Lead Sponsor: Hillel Yaffe Medical Center

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.

Detailed Description

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.

Study Timeline

• Status Verified: 2017-07
• Study First Submitted: 2017-07-09
• Study First Submitted QC: 2017-07-12
• Last Update Submitted: 2017-07-12
• Study First Posted: 2017-07-13
• Last Update Posted: 2017-07-13
• Study Start: 2017-07-20
• Primary Completion: 2017-12-20
• Study Completion: 2017-12-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Compressive draping	Compressive draping using adhesive incise drape	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)

Primary Outcome Measures

Name	Time	Method
Change on shoulder circumference	Immediate post-operative	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.