Shoulder ArthroscopyNCT03216590
The Effect of Draping on Swelling in Shoulder Arthroscopy
A study testing Compressive draping using adhesive incise drape in people with Shoulder Arthroscopy and Soft Tissue Swelling, run by Hillel Yaffe Medical Center.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shoulder Arthroscopy, Soft Tissue Swelling
- What is being tested?
- Compressive draping using adhesive incise drape
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 20 Jul 2017to 20 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Pregnant women.
- Arthroscopic procedure that was converted to an open ("mini-open") surgery.
- Patients who do not meet the above mentioned inclusion criteria.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Can Preoperative Compressive Draping Reduce Soft Tissue Swelling During Shoulder Arthroscopy? A Prospective Randomized Trial
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.
Read the 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
- Being tested
- Compressive draping using adhesive incise drape
- Keywords
- Shoulder Arthroscopy, Soft Tissue Swelling, Rotator Cuff Repair, Shoulder Arthroscopy Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compressive draping using adhesive incise drapeDevice
In the intervention group the shoulder will be drape with compressive draping using adhesive incise drape (Ioban™2 Antimicrobial Incise Drape, 3M Inc.,USA).
| Study group | Role | What they receive |
|---|---|---|
| Standard draping | No intervention | Shoulder arthroscopy will be performed using standard draping with the shoulder exposed. |
| Compressive draping | Experimental | 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) Receives: Device: Compressive draping using adhesive incise drape |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Immediate post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2017
- Study start20 Jul 2017 (estimated)
- Primary completion20 Dec 2017 (estimated)
- Study completion20 Dec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Shoulder ArthroscopyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- After signing an informed consent participants will be randomised to one of the two study groups.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Ofir Uri, Principal investigator, Hillel Yaffe Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03216590
- Sponsor's protocol ID
- HYMC-17-0033
- Status last verified
- Jul 2017
- First submitted
- 9 Jul 2017
- Last updated
- 13 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38379580
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Preoperative Compressive Draping Reduce Soft Tissue Swelling During Shoulder Arthroscopy? A Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT03216590
- Acronym / sponsor ID
- HYMC-17-0033
- Conditions
- Shoulder Arthroscopy, Soft Tissue Swelling
- Keywords
- Shoulder Arthroscopy, Soft Tissue Swelling, Rotator Cuff Repair, Shoulder Arthroscopy Complications
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- 20 Jul 2017 (estimated)
- Primary completion
- 20 Dec 2017 (estimated)
- Study completion
- 20 Dec 2017 (estimated)
- First posted
- 13 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- After signing an informed consent participants will be randomised to one of the two study groups.
| Arm | Type | Receives |
|---|---|---|
| Standard draping | No intervention | –Shoulder arthroscopy will be performed using standard draping with the shoulder exposed. |
| Compressive draping | Experimental | Device: Compressive draping using adhesive incise drapeAfter 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- Pregnant women.
- Arthroscopic procedure that was converted to an open ("mini-open") surgery.
- Patients who do not meet the above mentioned inclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Compressive draping using adhesive incise drapeIn the intervention group the shoulder will be drape with compressive draping using adhesive incise drape (Ioban™2 Antimicrobial Incise Drape, 3M Inc.,USA). | Device | Compressive draping |
Primary outcome
Change on shoulder circumference
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2017.
- Derived from this study: PubMed 38379580Uri 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ofir Uri principal investigator
Hillel Yaffe Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing Compressive draping using adhesive incise drape in people with Shoulder Arthroscopy and Soft Tissue Swelling, run by Hillel Yaffe Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ofir Uri, MD (+972-52-3863228, ofiruri@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change on shoulder circumference (time frame: Immediate post-operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03216590, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2017.