Ulcerative ColitisNCT01002287

An Evaluation of SprayShield in Reducing Post-Operative Adhesion Formation Following Major Open Abdominal Surgery

A study testing SprayShield Adhesion Barrier System and Good Surgical Technique Alone in people with Ulcerative Colitis and Familial Polyposis, run by Integra LifeSciences Corporation at 1 site 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

This will be a prospective, multi-center, randomized, single blind study to collect and evaluate post-market clinical data on the SprayShield Adhesion Barrier System as an adjuvant to good surgical technique for the reduction of postoperative adhesion formation following major open abdominal surgery. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Ulcerative Colitis, Familial Polyposis
What is being tested?: SprayShield Adhesion Barrier System and Good Surgical Technique Alone
Type of treatment: Medical device, Surgery or procedure
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 11 participants
Where: 1 siteUnited States
Study dates: Oct 2009to May 2011
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

Diagnosis of ulcerative colitis or familial polyposis and require two-stage surgery for treatment of either of these disorders will be eligible

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

Covidien
Bedford, Massachusetts, 01710

Other trials in United States

About this study

Official title: An Evaluation of the SprayShield Adhesion Barrier System in Reducing Post-Operative Adhesion in Abdominal Surgery

Conditions: Ulcerative Colitis, Familial Polyposis
Being tested: SprayShield Adhesion Barrier System, Good Surgical Technique Alone
Medical subject headings: Colitis, Ulcerative, Adenomatous Polyposis Coli

What participants receive

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

SprayShield Adhesion Barrier SystemDevice
Adhesion Barrier Device
Good Surgical Technique AloneProcedure or surgery
Good Surgical Technique Alone

Study groups in NCT01002287
Study group	Role	What they receive
SprayShield Adhesion Barrier	Experimental	SprayShield Adhesion Barrier Receives: Device: SprayShield Adhesion Barrier System
Control	Sham comparator	Good Surgical Technique Alone Receives: Procedure: Good Surgical Technique Alone

What is being measured

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

The Incidence of Adhesions, Defined as the Proportion of Subjects Presenting at the Follow-up Surgery (10-12 Weeks) With One or More Adhesions to the Midline Incision, Regardless of Extent and/or Severity.
Measured: 10-12 Weeks post Initial Surgery for J-Pouch

Secondary outcomes (3)

Severity of Adhesions
Worst midline adhesion severity score. The severity of adhesions was categorized as filmy thickness, avascular; moderate thickness, limited vascularity; and dense thickness, vascularised. The corresponding numeric severity ratings are "1", "2", and "3". Subjects without adhesions were assigned a severity rating of "0".
Measured: Average 10-12 weeks post surgery
Adhesion Involvement Along the Midline Incision (Percentage)
The proportion of the total length of the initial midline incision associated with any adhesion at the time of the follow-up surgery, as determined by dividing the length of the incision associated with adhesions (cm) by the overall initial midline incision length (cm). This calculates the extent of adhesion involvement as a percentage.
Measured: average 10-12 weeks post surgery
Mobilization Time
The time (minute) required to incise and mobilize the ileal loop in preparation for reanastomosis for ileostomy closure.
Measured: average 10-12 weeks post surgery

Timeline

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

Oct 2009May 2011

First posted27 Oct 2009 (estimated)
Study startOct 2009
Primary completionOct 2010
Study completionMay 2011

Why it stopped: Study was terminated for business purposes, not for safety or efficacy reasons.

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.
Other trials for Ulcerative ColitisStudies 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
Masking: Single blind
Who is masked: Participant
Enrolment: 11 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01002287
Sponsor's protocol ID: ABD-08-001
Status last verified: Nov 2014
First submitted: 26 Oct 2009
Last updated: 20 Nov 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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?

See locations

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All Ulcerative Colitis trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Evaluation of the SprayShield Adhesion Barrier System in Reducing Post-Operative Adhesion in Abdominal Surgery
ClinicalTrials.gov ID: NCT01002287
Acronym / sponsor ID: ABD-08-001
Conditions: Ulcerative Colitis, Familial Polyposis
Study type: Interventional
Recruitment status: TerminatedReason stopped: Study was terminated for business purposes, not for safety or efficacy reasons.
Enrolment: 11 participants (actual)
Lead sponsor: Integra LifeSciences CorporationIndustry (pharma, biotech, devices)
Study start: Oct 2009
Primary completion: Oct 2010 (actual)
Study completion: May 2011 (actual)
First posted: 27 Oct 2009 (estimated)
Results: Posted 29 Jan 2014

Clinical summary

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

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
SprayShield Adhesion Barrier	Experimental	Device: SprayShield Adhesion Barrier SystemSprayShield Adhesion Barrier
Control	Sham comparator	Procedure: Good Surgical Technique AloneGood Surgical Technique Alone

Who may qualify

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

Key inclusion criteria (1 listed)

Diagnosis of ulcerative colitis or familial polyposis and require two-stage surgery for treatment of either of these disorders will be eligible

Key exclusion criteria (0 listed)

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
SprayShield Adhesion Barrier SystemAdhesion Barrier Device	Device	SprayShield Adhesion Barrier
Good Surgical Technique AloneGood Surgical Technique Alone	Procedure or surgery	Control

Primary outcome

The Incidence of Adhesions, Defined as the Proportion of Subjects Presenting at the Follow-up Surgery (10-12 Weeks) With One or More Adhesions to the Midline Incision, Regardless of Extent and/or Severity.
Time frame: 10-12 Weeks post Initial Surgery for J-Pouch

3 secondary outcomes

Severity of Adhesions
Time frame: Average 10-12 weeks post surgery
Adhesion Involvement Along the Midline Incision (Percentage)
Time frame: average 10-12 weeks post surgery
Mobilization Time
Time frame: average 10-12 weeks post surgery

Results and safety

Results posted to the registry on 29 Jan 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
SprayShield Adhesion Barrier	8	8
Control	3	3

Primary outcome: The Incidence of Adhesions, Defined as the Proportion of Subjects Presenting at the Follow-up Surgery (10-12 Weeks) With One or More Adhesions to the Midline Incision, Regardless of Extent and/or Severity.

Time frame: 10-12 Weeks post Initial Surgery for J-Pouch. Number. Unit: percentage of subjects with adhesions

Measure	SprayShield Adhesion Barrier n = 8	Control n = 3
Value	37.5	66.7

Population analysed: All 11 patients met the per protocol population requirements specified in the protocol and statistical analysis plan.

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
SprayShield Adhesion Barrier	2 of 8 (25%)	4 of 8 (50%)	Not reported
Control	1 of 3 (33.3%)	0 of 3 (0%)	Not reported

Limitations and caveats (from the sponsor): Early termination leading to small numbers of subjects analyzed

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Ulcerative Colitis

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RecruitingObservational study
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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.

The record lists no contact. Use the official record to reach the sponsor.

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

Questions about this trial

What is this clinical trial studying?

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 1 inclusion and 0 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 20 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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. Some participants in this study may receive a placebo. 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 29 Jan 2014). 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?

The Incidence of Adhesions, Defined as the Proportion of Subjects Presenting at the Follow-up Surgery (10-12 Weeks) With One or More Adhesions to the Midline Incision, Regardless of Extent and/or Severity. (time frame: 10-12 Weeks post Initial Surgery for J-Pouch). 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 NCT01002287.

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 20 Nov 2014.