NCT00565643

Brief 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. Secondary outcomes will include measures of safety, operative times (ex., incision-delivery; total operative time).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
753

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Nov 2007

Longer than P75 for phase_4

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2007

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

November 29, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 30, 2007

Completed
6.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

April 22, 2016

Completed
Last Updated

May 14, 2024

Status Verified

April 1, 2024

Enrollment Period

6.9 years

First QC Date

November 29, 2007

Results QC Date

December 30, 2015

Last Update Submit

April 22, 2024

Conditions

AdhesionsCesarean SectionDelivery, Obstetric

Keywords

AdhesionSeprafilmCesarean section

Outcome Measures

Primary Outcomes (2)

  • Incidence of Adhesions

    The Percentage of participants with one or more adhesions, regardless of the extent or severity

    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).

    3 to 5 years

Secondary Outcomes (5)

  • Post-operative Hemoglobin

    1 to 5 years

  • Post-operative White Blood Cell Count

    1 to 5 years

  • Post-Operative Complications

    1 to 5 years

  • Post-operative Maximum Temperature Following Randomization

    1 to 5 years

  • Operative Times at Subsequent Delivery

    3 to 5 years

Study Arms (2)

HA-CMC Group

EXPERIMENTAL

Hyaluronic Acid-Carboxymethylcellulose placed as an adhesion barrier

Device: modified sodium hyaluronic acid and carboxymethylcellulose

Routine Closure Group

PLACEBO COMPARATOR

Routine Closure without placement of an adhesion barrier

Device: Placebo

Interventions

modified sodium hyaluronic acid and carboxymethylcelluloseDEVICE

Adhesion barrier applied at the time of initial cesarean delivery

Also known as: Seprafilm Adhesion Barrier
HA-CMC Group
PlaceboDEVICE

Routine abdominal closure without placement of adhesion barrier

Routine Closure Group

Eligibility Criteria

Age18 Years - 55 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Pregnant women who are planning or have the potential to undergo cesarean delivery
  • Age over 18
  • Able to consent to study

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Winthrop University Hospital

Mineola, New York, 11501, United States

Location

SUNY Stony Brook University Hospital

Stony Brook, New York, 11501, United States

Location

Lehigh Valley Hospital

Allentown, Pennsylvania, 18103, United States

Location

MeSH Terms

Conditions

Tissue Adhesions

Condition Hierarchy (Ancestors)

CicatrixFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Daniel Kiefer
Organization
Lehigh Valley Health Network
daniel_g.kiefer@lvhn.org
484-664-7521

Study Officials

  • Daniel G Kiefer, M.D.

    Lehigh Valley Health Network

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 29, 2007

First Posted

November 30, 2007

Study Start

November 1, 2007

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

May 14, 2024

Results First Posted

April 22, 2016

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

US(3)