The Effect of Draping on Swelling in Shoulder Arthroscopy

NCT ID: NCT03216590

Last Updated: 2017-07-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-20
• Study Completion Date: 2017-12-20

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.

Conditions

Shoulder Arthroscopy; Soft Tissue Swelling

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Standard draping

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Compressive draping

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)

Group Type: EXPERIMENTAL

Compressive draping using adhesive incise drape

Intervention Type: DEVICE

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

Interventions

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).

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hillel Yaffe Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ofir Uri

Role: PRINCIPAL_INVESTIGATOR

Hillel Yaffe Medical Center

Central Contacts

Ofir Uri, MD

Role: CONTACT

ofiruri@gmail.com

+972-52-3863228

References

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.

Reference Type: DERIVED

PMID: 38379580 (View on PubMed)

Other Identifiers

HYMC-17-0033

Identifier Type: -

Identifier Source: org_study_id