AdhesionsPhase 4NCT00565643
Seprafilm® Adhesion Barrier and Cesarean Delivery
A Phase 4 study testing modified sodium hyaluronic acid and carboxymethylcellulose in people with Adhesions and Cesarean Section, run by Winthrop University Hospital at 3 sites in United States.
Trial summary
A multicenter, randomized, controlled, single blinded study to evaluate the effectiveness of Seprafilm® Adhesion Barrier in reducing adhesion formation in cesarean deliveries. Primary outcome will be measurement of the extent and severity of adhesions at the time of subsequent cesarean delivery. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Adhesions, Cesarean Section, Delivery, Obstetric
- What is being tested?
- modified sodium hyaluronic acid and carboxymethylcellulose
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 753 participants
- Where
- 3 sitesUnited States
- Study dates
- Nov 2007to Oct 2014
- Phase
- Phase 4
- 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 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Pregnant women who are planning or have the potential to undergo cesarean delivery
- Age over 18
- Able to consent to study
Who cannot join
- Planned tubal ligation
- Known allergy to hyaluronic acid
- Medical or other serious condition which will interfere with compliance and/or ability to complete study protocol
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Lehigh Valley Hospital
Allentown, Pennsylvania, 18103
Winthrop University Hospital
Mineola, New York, 11501
SUNY Stony Brook University Hospital
Stony Brook, New York, 11501
About this study
Official title: A Multicenter, Randomized, Controlled Trial of Seprafilm® Adhesion Barrier to Reduce Adhesion Formation Following Cesarean Delivery
A multicenter, randomized, controlled, single blinded study to evaluate the effectiveness of Seprafilm® Adhesion Barrier in reducing adhesion formation in cesarean deliveries. Primary outcome will be measurement of the extent and severity of adhesions at the time of subsequent cesarean delivery. Secondary outcomes will include measures of safety, operative times (ex., incision-delivery; total operative time).
Read the detailed description
Patients presenting to labor and delivery for delivery will be screened for eligibility. If a patient meets the inclusion and exclusion criteria, she will be offered enrollment in the study. After the project and informed consent are reviewed with the patient and all questions are answered, she will be asked to sign the informed consent. At this point, she will be considered a candidate for randomization.
If the patient subsequently undergoes a cesarean delivery, she will be randomized to either:
- Group A - Placement of Seprafilm® prior to abdominal closure
- Group B - Routine closure without placement of Seprafilm® The chances of being assigned to either group will be equal (i.e., 1:1 randomization). The patient will be blinded with regard to Seprafilm placement.
The investigators will collect additional data about the patient, her antepartum course, intra-operative events, and post-operative course. There are no additional tests or procedures ordered or performed during the hospital stay as part of this protocol. Enrollment in this study is not expected to alter the patient's length of stay.
The antepartum, operative, and post-operative care of the patient will as directed by the patient's physician and participating institutions's standard policies and procedures. This study in no way changes or directs the care the patient would receive, except with regard to the placement of Seprafilm® Adhesion Barrier.
A short-term telephone follow-up will be conducted approximately 6-8 weeks following randomization to assess for immediate post-operative complications.
If a patient becomes pregnant again and undergoes a repeat cesarean delivery at a participating institution, the location and severity of adhesions (if any) would be assessed at the time of repeat cesarean delivery. The investigators will extract additional data from the chart including operative times, blood loss, and complications. An evaluation of adhesions would conclude the patient's participation in the study.
- Conditions
- Adhesions, Cesarean Section, Delivery, Obstetric
- Being tested
- modified sodium hyaluronic acid and carboxymethylcellulose, Placebo
- Keywords
- Adhesion, Seprafilm, Cesarean section
- Medical subject headings
- Tissue Adhesions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
modified sodium hyaluronic acid and carboxymethylcelluloseDevice
Also called Seprafilm Adhesion Barrier
Adhesion barrier applied at the time of initial cesarean delivery
PlaceboDevice
Routine abdominal closure without placement of adhesion barrier
| Study group | Role | What they receive |
|---|---|---|
| HA-CMC Group | Experimental | Hyaluronic Acid-Carboxymethylcellulose placed as an adhesion barrier Receives: Device: modified sodium hyaluronic acid and carboxymethylcellulose |
| Routine Closure Group | Placebo comparator | Routine Closure without placement of an adhesion barrier Receives: Device: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adhesions
The Percentage of participants with one or more adhesions, regardless of the extent or severity
Measured: 3 to 5 years
Adhesion Score
Adhesion score. Derived by assigning 1 point for filmy adhesion and 2 points for dense adhesions at each of 6 possible sites in the abdomen. Thus the score can range from 0 (i.e., no adhesions at any location) to 12 (dense adhesions at each site).
Measured: 3 to 5 years
Secondary outcomes (5)
Post-operative Hemoglobin
Hemoglobin level following randomization delivery - used to determine if there was a difference in blood loss between the two groups
Measured: 1 to 5 years
Post-operative White Blood Cell Count
Post-operative White blood cell count following randomization delivery - used to determine if there was difference in immune response or infection between the groups
Measured: 1 to 5 years
Post-Operative Complications
Percentage of patients experiencing any of the predefined post-operative complications following randomization
Measured: 1 to 5 years
Post-operative Maximum Temperature Following Randomization
Maximum temperature of patient, >24 hours following randomization delivery
Measured: 1 to 5 years
Operative Times at Subsequent Delivery
Amount of time spent at the time of the subsequent delivery
Measured: 3 to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2007 (estimated)
- Study startNov 2007
- Primary completionOct 2014
- Study completionOct 2014
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 AdhesionsStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 753 participants (actual)
Sponsor and investigators
- Lead sponsor
- Winthrop University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Stony Brook University, Lehigh Valley Hospital
- Responsible party
- Principal investigator, Daniel Kiefer, Winthrop University Hospital
- Investigators
- Daniel G Kiefer, M.D., Principal investigator, Lehigh Valley Health Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00565643
- Sponsor's protocol ID
- IRB No. 07023
- Other IDs
- MO1RR10710
- Status last verified
- Apr 2024
- First submitted
- 29 Nov 2007
- Last updated
- 14 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Controlled Trial of Seprafilm® Adhesion Barrier to Reduce Adhesion Formation Following Cesarean Delivery
- ClinicalTrials.gov ID
- NCT00565643
- Acronym / sponsor ID
- IRB No. 07023
- Conditions
- Adhesions, Cesarean Section, Delivery, Obstetric
- Keywords
- Adhesion, Seprafilm, Cesarean section
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 753 participants (actual)
- Lead sponsor
- Winthrop University HospitalUniversity, hospital or other
- Collaborators
- Stony Brook University, Lehigh Valley Hospital
- Study start
- Nov 2007
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 30 Nov 2007 (estimated)
- Results
- Posted 22 Apr 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A multicenter, randomized, controlled, single blinded study to evaluate the effectiveness of Seprafilm® Adhesion Barrier in reducing adhesion formation in cesarean deliveries. Primary outcome will be measurement of the extent and severity of adhesions at the time of subsequent cesarean delivery. Secondary outcomes will include measures of safety, operative times (ex., incision-delivery; total operative time).
Detailed description
Patients presenting to labor and delivery for delivery will be screened for eligibility. If a patient meets the inclusion and exclusion criteria, she will be offered enrollment in the study. After the project and informed consent are reviewed with the patient and all questions are answered, she will be asked to sign the informed consent. At this point, she will be considered a candidate for randomization.
If the patient subsequently undergoes a cesarean delivery, she will be randomized to either:
- Group A - Placement of Seprafilm® prior to abdominal closure
- Group B - Routine closure without placement of Seprafilm® The chances of being assigned to either group will be equal (i.e., 1:1 randomization). The patient will be blinded with regard to Seprafilm placement.
The investigators will collect additional data about the patient, her antepartum course, intra-operative events, and post-operative course. There are no additional tests or procedures ordered or performed during the hospital stay as part of this protocol. Enrollment in this study is not expected to alter the patient's length of stay.
The antepartum, operative, and post-operative care of the patient will as directed by the patient's physician and participating institutions's standard policies and procedures. This study in no way changes or directs the care the patient would receive, except with regard to the placement of Seprafilm® Adhesion Barrier.
A short-term telephone follow-up will be conducted approximately 6-8 weeks following randomization to assess for immediate post-operative complications.
If a patient becomes pregnant again and undergoes a repeat cesarean delivery at a participating institution, the location and severity of adhesions (if any) would be assessed at the time of repeat cesarean delivery. The investigators will extract additional data from the chart including operative times, blood loss, and complications. An evaluation of adhesions would conclude the patient's participation in the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HA-CMC Group | Experimental | Device: modified sodium hyaluronic acid and carboxymethylcelluloseHyaluronic Acid-Carboxymethylcellulose placed as an adhesion barrier |
| Routine Closure Group | Placebo comparator | Device: PlaceboRoutine Closure without placement of an adhesion barrier |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Pregnant women who are planning or have the potential to undergo cesarean delivery
- Age over 18
- Able to consent to study
Key exclusion criteria (3 listed)
- Planned tubal ligation
- Known allergy to hyaluronic acid
- Medical or other serious condition which will interfere with compliance and/or ability to complete study protocol
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 |
|---|---|---|
| modified sodium hyaluronic acid and carboxymethylcelluloseAlso: Seprafilm Adhesion BarrierAdhesion barrier applied at the time of initial cesarean delivery | Device | HA-CMC Group |
| PlaceboRoutine abdominal closure without placement of adhesion barrier | Device | Routine Closure Group |
Primary outcome
Incidence of Adhesions
Time frame: 3 to 5 years
The Percentage of participants with one or more adhesions, regardless of the extent or severity
Adhesion Score
Time frame: 3 to 5 years
Adhesion score. Derived by assigning 1 point for filmy adhesion and 2 points for dense adhesions at each of 6 possible sites in the abdomen. Thus the score can range from 0 (i.e., no adhesions at any location) to 12 (dense adhesions at each site).
5 secondary outcomes
Post-operative Hemoglobin
Time frame: 1 to 5 years
Post-operative White Blood Cell Count
Time frame: 1 to 5 years
Post-Operative Complications
Time frame: 1 to 5 years
Post-operative Maximum Temperature Following Randomization
Time frame: 1 to 5 years
Operative Times at Subsequent Delivery
Time frame: 3 to 5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Daniel G Kiefer, M.D. principal investigator
Lehigh Valley Health Network
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing modified sodium hyaluronic acid and carboxymethylcellulose in people with Adhesions and Cesarean Section, run by Winthrop University Hospital at 3 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 3 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: finished, as of the sponsor's last update on 14 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Apr 2016). 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?
Incidence of Adhesions (time frame: 3 to 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 May 2024.