The Effect of Draping on Swelling in Shoulder Arthroscopy

Hillel Yaffe Medical Center

Status: Unknown

Conditions: Shoulder Arthroscopy; Soft Tissue Swelling

Treatments: Device: Compressive draping using adhesive incise drape

Study type: Interventional

Funder types: Other

Identifiers

NCT03216590

HYMC-17-0033

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria for the study are defined as:

1. Surgery indicated for chronic symptomatic RC tear unresponsive to non-operative treatment over a minimal period of 6 months.
2. Small to medium size tears (<3 cm).
3. Age older than 18 years.
4. ASA score 1or 2.
5. Body mass index (BMI) < 35.
6. Willingness to provide an informed consent.

Exclusion criteria:

1. Pregnant women.
2. Arthroscopic procedure that was converted to an open ("mini-open") surgery.
3. Patients who do not meet the above mentioned inclusion criteria.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Standard draping

No Intervention group

Description:

Shoulder arthroscopy will be performed using standard draping with the shoulder exposed.

Compressive draping

Experimental group

Description:

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)

Treatment:

Device: Compressive draping using adhesive incise drape