SurgeryNCT02725788

Trial Comparing Peripheral I.V. Catheter Complication Rates of Two Different Catheter Dressings

A study testing New PIV Dressing and Standard PIV Dressing in people with Surgery, run by Solventum US LLC at 5 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

A multi-center randomized control trial comparing the dressing wear times of two different transparent film dressings when used to secure peripheral intravenous catheters of hospitalized adult patients. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Surgery
What is being tested?: New PIV Dressing and Standard PIV Dressing
Type of treatment: Injection or infusion, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 247 participants
Where: 5 sitesUnited States
Study dates: Sep 2014to May 2015
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

At least 18 years of age, or of consenting age;
Admitted or going to be admitted to the hospital;
Requires peripheral IV therapy (catheter) for an anticipated 72 hours or longer;
Has an insertion site in the forearm or hand free of phlebitis, infiltration, dermatitis, burns, lesions or tattoos;
Demonstrates cooperation with a catheter insertion and the securement protocol; and
Patient or legally authorized representative is willing and able to provide written informed consent and authorization for use and disclosure of Protected Health Information

Who cannot join

Is a current participant or a past participant in this study;
If the subject already has a functioning PIV in place, not requiring a replacement catheter
If the study PIV catheter site will be placed below an old infusion site;
If the study PIV site needs to be immobilized with a splint or other device;
Has a documented or a known allergy or sensitivity to a medical adhesive product such as transparent film adhesive dressings, tapes, or liquid skin protectants;
Requires the application of a gauze pad, a topical ointment or solution under the dressing in addition to the prep(s) required in the protocol;

Show all 9Show fewer

Will require a power injection through the study PIV catheter for a radiologic procedure during participation in this study;
Will require a numbing agent prior to PIV insertion; or
Will require the use of ultrasound for the PIV catheter insertion.

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

United States5 sites

University of North Carolina
Chapel Hill, North Carolina, 27599
MetroHealth Medical Center
Cleveland, Ohio, 44109
University of Nebraska Medical Center
Omaha, Nebraska, 68198-4031
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
Virginia Commonwealth University Medical Center
Richmond, Virginia, 23298

Other trials in United States

About this study

Official title: A Multi-Center, Prospective, Randomized Trial Comparing the Peripheral I.V. Catheter Complication Rates of Two Different Catheter Dressings

Read the detailed description

A multi-center, prospective, randomized control trial comparing the dressing wear time, complication rates and cost of two different transparent film dressing when used as intended for peripheral intravenous catheter site protection and securement in five U.S. hospitals.

Conditions: Surgery
Being tested: New PIV Dressing, Standard PIV Dressing

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

New PIV DressingDevice
A commercially available breathable, transparent film dressing with a soft-cloth border, notch and securement tape strip. The dressing system is used in the study to cover a peripheral intravenous catheter insertion site and secure the catheter. Dressing system is to remain in place until the PIV catheter is discontinued which is anticipated to be 72 hours. The dressing and PIV site will be observed daily. If dressing excessively lifts from the skin, the dressing system will be replaced with the same, assigned dressing system. The number of dressing replacements and the duration of wear will be measured while the same study PIV catheter dwells, an average of 72 hours during the subject's hospitalization.
Standard PIV DressingDevice
A commercially available breathable, transparent film dressing used with a one inch width piece of Transpore™ medical tape. The dressing system is used in the study to cover a peripheral intravenous catheter insertion site and secure the catheter. Dressing system is to remain in place until catheter is discontinued which is anticipated to be 72 hours. The dressing and PIV site will be observed daily. If dressing excessively lifts from the skin, the dressing system will be replaced with the same, assigned dressing system. The number of dressing replacements and the duration of wear will be measured while the same study PIV catheter dwells, an average of 72 hours during the subject's hospitalization.

Study groups in NCT02725788
Study group	Role	What they receive
New PIV Dressing	Experimental	Bordered, notched dressing that covers, secures peripheral intravenous (PIV) catheter Receives: Device: New PIV Dressing
Standard PIV Dressing	Other	Film,adhesive dressing that covers, secures peripheral intravenous (PIV) catheter and used with a medical grade tape Receives: Device: Standard PIV Dressing

What is being measured

The primary outcome is the main question the study is designed to answer.

Dressing Wear Time
Dressing wear time is the time from dressing application to removal, i.e. catheter no longer needed or catheter-related complication occurs (remove dressing and catheter) OR excessive dressing lift requiring dressing replacement.
Measured: Dressing wear time was assessed daily and 8 month dressing wear data are presented

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2014May 2015

First posted1 Apr 2016 (estimated)
Study startSep 2014
Primary completionMay 2015
Study completionMay 2015

Why it stopped: Due to futility

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (11)Papers the sponsor has linked to this study.
Other trials for SurgeryStudies 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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 247 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02725788
Sponsor's protocol ID: EM-05-013243
Status last verified: Sep 2024
First submitted: 15 Jan 2015
Last updated: 24 Oct 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No: Not required based on FDAA requirements

Publications

Wood D. A comparative study of two securement techniques for short peripheral intravenous catheters. J Intraven Nurs. 1997 Nov-Dec;20(6):280-5.
PubMed 9423389
Alexander M. Corrigan A. Infusion Nurses Society: Infusion nursing an evidence-based approach. St. Louis, Mo.: Saunders-Elsevier; 2010.
Royer T. Improving short peripheral IV outcomes: a clinical trial of two securement methods. Journal of the Association for Vascular Access. 2003; 8(4): 45-49.
Sheppard K, LeDesma M, Morris NL, O'Connor K. A prospective study of two intravenous catheter securement techniques in a skilled nursing facility. J Intraven Nurs. 1999 May-Jun;22(3):151-6.
PubMed 10640079
Rosenthal K. Get a hold on costs and safety with securement devices. Nurs Manage. 2005 May;36(5):52-4. doi: 10.1097/00006247-200505000-00014.
PubMed 15879998
Schears GJ. Summary of product trials for 10, 164 patients: comparing an intravenous stabilizing device to tape. J Infus Nurs. 2006 Jul-Aug;29(4):225-31. doi: 10.1097/00129804-200607000-00009.
PubMed 16858255
Bausone-Gazda D, Lefaiver CA, Walters SA. A randomized controlled trial to compare the complications of 2 peripheral intravenous catheter-stabilization systems. J Infus Nurs. 2010 Nov-Dec;33(6):371-84. doi: 10.1097/NAN.0b013e3181f85be2.
PubMed 21079465
Dunnett CW, Gent M. An alternative to the use of two-sided tests in clinical trials. Stat Med. 1996 Aug 30;15(16):1729-38. doi: 10.1002/(SICI)1097-0258(19960830)15:163.0.CO;2-M.
PubMed 8870155
Hwang IK, Morikawa T. Design issues in noninferiority/equivalence trials. Drug Information journal 33: 1205-18, 1999.
Tripathi S, Kaushik V, Singh V. Peripheral IVs: factors affecting complications and patency--a randomized controlled trial. J Infus Nurs. 2008 May-Jun;31(3):182-8. doi: 10.1097/01.NAN.0000317704.03415.b9.
PubMed 18496062
Tripepi-Bova KA, Woods KD, Loach MC. A comparison of transparent polyurethane and dry gauze dressings for peripheral i.v. catheter sites: rates of phlebitis, infiltration, and dislodgment by patients. Am J Crit Care. 1997 Sep;6(5):377-81.
PubMed 9283675

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 24 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multi-Center, Prospective, Randomized Trial Comparing the Peripheral I.V. Catheter Complication Rates of Two Different Catheter Dressings
ClinicalTrials.gov ID: NCT02725788
Acronym / sponsor ID: EM-05-013243
Conditions: Surgery
Study type: Interventional
Recruitment status: TerminatedReason stopped: Due to futility
Enrolment: 247 participants (actual)
Lead sponsor: Solventum US LLCIndustry (pharma, biotech, devices)
Collaborators: 3M
Study start: Sep 2014
Primary completion: May 2015 (actual)
Study completion: May 2015 (actual)
First posted: 1 Apr 2016 (estimated)
Results: Posted 24 Apr 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
New PIV Dressing	Experimental	Device: New PIV DressingBordered, notched dressing that covers, secures peripheral intravenous (PIV) catheter
Standard PIV Dressing	Other	Device: Standard PIV DressingFilm,adhesive dressing that covers, secures peripheral intravenous (PIV) catheter and used with a medical grade tape

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

At least 18 years of age, or of consenting age;
Admitted or going to be admitted to the hospital;
Requires peripheral IV therapy (catheter) for an anticipated 72 hours or longer;
Has an insertion site in the forearm or hand free of phlebitis, infiltration, dermatitis, burns, lesions or tattoos;
Demonstrates cooperation with a catheter insertion and the securement protocol; and

Key exclusion criteria (9 listed)

Is a current participant or a past participant in this study;
If the subject already has a functioning PIV in place, not requiring a replacement catheter
If the study PIV catheter site will be placed below an old infusion site;
If the study PIV site needs to be immobilized with a splint or other device;
Has a documented or a known allergy or sensitivity to a medical adhesive product such as transparent film adhesive dressings, tapes, or liquid skin protectants;

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
New PIV DressingA commercially available breathable, transparent film dressing with a soft-cloth border, notch and securement tape strip. The dressing system is used in the study to cover a peripheral intravenous catheter insertion site and secure the catheter. Dressing system is to remain in place until the PIV catheter is discontinued which is anticipated to be 72 hours. The dressing and PIV site will be observed daily. If dressing excessively lifts from the skin, the dressing system will be replaced with the same, assigned dressing system. The number of dressing replacements and the duration of wear will be measured while the same study PIV catheter dwells, an average of 72 hours during the subject's hospitalization.	Device	New PIV Dressing
Standard PIV DressingA commercially available breathable, transparent film dressing used with a one inch width piece of Transpore™ medical tape. The dressing system is used in the study to cover a peripheral intravenous catheter insertion site and secure the catheter. Dressing system is to remain in place until catheter is discontinued which is anticipated to be 72 hours. The dressing and PIV site will be observed daily. If dressing excessively lifts from the skin, the dressing system will be replaced with the same, assigned dressing system. The number of dressing replacements and the duration of wear will be measured while the same study PIV catheter dwells, an average of 72 hours during the subject's hospitalization.	Device	Standard PIV Dressing

Primary outcome

Dressing Wear Time
Time frame: Dressing wear time was assessed daily and 8 month dressing wear data are presented
Dressing wear time is the time from dressing application to removal, i.e. catheter no longer needed or catheter-related complication occurs (remove dressing and catheter) OR excessive dressing lift requiring dressing replacement.

Results and safety

Results posted to the registry on 24 Apr 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
New Dressing	123	122
Standard PIV Dressing	124	122

Primary outcome: Dressing Wear Time

Time frame: Dressing wear time was assessed daily and 8 month dressing wear data are presented. Median (Full Range). Unit: Days

Measure	New Dressing n = 122	Standard PIV Dressing n = 122
Value	2.1 (0 to 7.0)	2.1 (0 to 7.7)

Population analysed: All subjects randomized except three subjects who either failed to have a study dressing applied or whom could not have the primary endpoint ascertained.

Adverse events

Time frame: 8 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
New Dressing	0 of 123 (0%)	0 of 123 (0%)	Not reported
Standard PIV Dressing	0 of 124 (0%)	0 of 124 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 9423389Wood D. A comparative study of two securement techniques for short peripheral intravenous catheters. J Intraven Nurs. 1997 Nov-Dec;20(6):280-5.
BackgroundAlexander M. Corrigan A. Infusion Nurses Society: Infusion nursing an evidence-based approach. St. Louis, Mo.: Saunders-Elsevier; 2010.
BackgroundRoyer T. Improving short peripheral IV outcomes: a clinical trial of two securement methods. Journal of the Association for Vascular Access. 2003; 8(4): 45-49.
Background: PubMed 10640079Sheppard K, LeDesma M, Morris NL, O'Connor K. A prospective study of two intravenous catheter securement techniques in a skilled nursing facility. J Intraven Nurs. 1999 May-Jun;22(3):151-6.
Background: PubMed 15879998Rosenthal K. Get a hold on costs and safety with securement devices. Nurs Manage. 2005 May;36(5):52-4. doi: 10.1097/00006247-200505000-00014.
Background: PubMed 16858255Schears GJ. Summary of product trials for 10, 164 patients: comparing an intravenous stabilizing device to tape. J Infus Nurs. 2006 Jul-Aug;29(4):225-31. doi: 10.1097/00129804-200607000-00009.
Background: PubMed 21079465Bausone-Gazda D, Lefaiver CA, Walters SA. A randomized controlled trial to compare the complications of 2 peripheral intravenous catheter-stabilization systems. J Infus Nurs. 2010 Nov-Dec;33(6):371-84. doi: 10.1097/NAN.0b013e3181f85be2.
Background: PubMed 8870155Dunnett CW, Gent M. An alternative to the use of two-sided tests in clinical trials. Stat Med. 1996 Aug 30;15(16):1729-38. doi: 10.1002/(SICI)1097-0258(19960830)15:163.0.CO;2-M.
BackgroundHwang IK, Morikawa T. Design issues in noninferiority/equivalence trials. Drug Information journal 33: 1205-18, 1999.
Background: PubMed 18496062Tripathi S, Kaushik V, Singh V. Peripheral IVs: factors affecting complications and patency--a randomized controlled trial. J Infus Nurs. 2008 May-Jun;31(3):182-8. doi: 10.1097/01.NAN.0000317704.03415.b9.
Background: PubMed 9283675Tripepi-Bova KA, Woods KD, Loach MC. A comparison of transparent polyurethane and dry gauze dressings for peripheral i.v. catheter sites: rates of phlebitis, infiltration, and dislodgment by patients. Am J Crit Care. 1997 Sep;6(5):377-81.
Individual participant dataSharing planned: No. Not required based on FDAA requirements

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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.

Mark E Rupp, MD principal investigator

University of Nebraska

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing New PIV Dressing and Standard PIV Dressing in people with Surgery, run by Solventum US LLC at 5 sites in United States.

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 9 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: stopped early, as of the sponsor's last update on 24 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Yes. Results are posted in the registry (first posted 24 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dressing Wear Time (time frame: Dressing wear time was assessed daily and 8 month dressing wear data are presented). 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 NCT02725788, which also lists 11 linked publications.

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 24 Oct 2024.