The Effect of Draping on Swelling in Shoulder Arthroscopy

Shoulder Arthroscopy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03216590
• Other study ID #: HYMC-17-0033
• Status: Not yet recruiting
• Phase: N/A
• First received: July 9, 2017
• Last updated: July 12, 2017
• Start date: July 20, 2017
• Est. completion date: December 20, 2017

Study information

• Verified date: July 2017
• Source: Hillel Yaffe Medical Center
• Contact: Ofir Uri, MD
• Phone: +972-52-3863228
• Email: ofiruri[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: December 20, 2017
• Est. primary completion date: December 20, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Shoulder Arthroscopy
• Soft Tissue Swelling

Intervention

Device:
• Compressive draping using adhesive incise drape
In the intervention group the shoulder will be drape with compressive draping using adhesive incise drape (Ioban™2 Antimicrobial Incise Drape, 3M Inc.,USA).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hillel Yaffe Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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