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Post Market Study for an Adhesion Barrier Following Laparoscopic Myomectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00891657
Recruitment Status : Completed
First Posted : May 1, 2009
Results First Posted : August 31, 2010
Last Update Posted : September 7, 2017
Sponsor:
Information provided by (Responsible Party):
Integra LifeSciences Corporation

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Prevention
Conditions Fibroid
Myoma
Leiomyoma
Intervention Device: SprayShield™
Enrollment 15
Recruitment Details Between November 10, 2008 and March 4, 2009, a total of 15 subjects were consented for potential participation, of whom all 15 subjects were randomized. There were no intra-operative screen failures.
Pre-assignment Details  
Arm/Group Title SprayShield™ Control
Hide Arm/Group Description The SprayShield™ is a synthetic, sprayable polyethylene glycol (PEG) based absorbable gel adhesion barrier, that consists of two liquids that when mixed together rapidly cross-link to form a biocompatible absorbable flexible hydrogel that conforms and adheres to the tissues to which it is applied. The subjects randomized to the Control group received standard good surgical care, excluding any use of anti-adhesion products.
Period Title: Overall Study
Started 9 6
Completed 8 5
Not Completed 1 1
Reason Not Completed
Withdrawal by Subject             1             1
Arm/Group Title SprayShield™ Control Total
Hide Arm/Group Description The SprayShield™ is a synthetic, sprayable polyethylene glycol (PEG) based absorbable gel adhesion barrier, that consists of two liquids that when mixed together rapidly cross-link to form a biocompatible absorbable flexible hydrogel that conforms and adheres to the tissues to which it is applied. The subjects randomized to the Control group received standard good surgical care, excluding any use of anti-adhesion products. Total of all reporting groups
Overall Number of Baseline Participants 9 6 15
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 6 participants 15 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
9
 100.0%
6
 100.0%
15
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 9 participants 6 participants 15 participants
35.8  (4.6) 44.3  (3.3) 39.2  (5.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 6 participants 15 participants
Female
9
 100.0%
6
 100.0%
15
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Germany Number Analyzed 9 participants 6 participants 15 participants
9 6 15
1.Primary Outcome
Title Number of Sites Adherent to the Uterus
Hide Description The number of times an adhesion is attached to the uterus.
Time Frame 8-12 weeks post myomectomy
Hide Outcome Measure Data
Hide Analysis Population Description
Number of subjects to have had a second laparoscopic look.
Arm/Group Title SprayShield™ Control
Hide Arm/Group Description:
The SprayShield™ is a synthetic, sprayable polyethylene glycol (PEG) based absorbable gel adhesion barrier, that consists of two liquids that when mixed together rapidly cross-link to form a biocompatible absorbable flexible hydrogel that conforms and adheres to the tissues to which it is applied.
The subjects randomized to the Control group received standard good surgical care, excluding any use of anti-adhesion products.
Overall Number of Participants Analyzed 8 5
Mean (Standard Deviation)
Unit of Measure: Adhesion Sites
1.1  (1.0) 0.6  (0.9)
2.Primary Outcome
Title Mean Severity Score of Sites Adherent to the Uterus
Hide Description The scoring for severity is as follows: 0=no adhesions, 1=filmy, avascular adhesions, 2=vascular and/or dense adhesions, and 3=cohesive adhesions.
Time Frame 8-12 weeks post myomectomy
Hide Outcome Measure Data
Hide Analysis Population Description
Number of subjects to have had a second laparoscopic look.
Arm/Group Title SprayShield™ Control
Hide Arm/Group Description:
The SprayShield™ is a synthetic, sprayable polyethylene glycol (PEG) based absorbable gel adhesion barrier, that consists of two liquids that when mixed together rapidly cross-link to form a biocompatible absorbable flexible hydrogel that conforms and adheres to the tissues to which it is applied.
The subjects randomized to the Control group received standard good surgical care, excluding any use of anti-adhesion products.
Overall Number of Participants Analyzed 8 5
Mean (Standard Deviation)
Unit of Measure: Scores on a Scale
1.63  (1.06) 0.8  (1.1)
3.Primary Outcome
Title Mean Extent Score of Sites Adherent to the Uterus
Hide Description 0 =no adhesions, 1=covering <25% of locations' total area, 2=covering 26% to 50% of locations' total area, and 3=covering >51% of locations' total area.
Time Frame 8-12 weeks post myomectomy
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title SprayShield™ Control
Hide Arm/Group Description:
The SprayShield™ is a synthetic, sprayable polyethylene glycol (PEG) based absorbable gel adhesion barrier, that consists of two liquids that when mixed together rapidly cross-link to form a biocompatible absorbable flexible hydrogel that conforms and adheres to the tissues to which it is applied.
The subjects randomized to the Control group received standard good surgical care, excluding any use of anti-adhesion products.
Overall Number of Participants Analyzed 8 5
Mean (Standard Deviation)
Unit of Measure: Scores on a Scale
0.92  (0.66) 0.6  (0.89)
4.Primary Outcome
Title Area of Sites Adherent to the Uterus (cm^2)
Hide Description [Not Specified]
Time Frame 8-12 weeks post myomectomy
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title SprayShield™ Control
Hide Arm/Group Description:
The SprayShield™ is a synthetic, sprayable polyethylene glycol (PEG) based absorbable gel adhesion barrier, that consists of two liquids that when mixed together rapidly cross-link to form a biocompatible absorbable flexible hydrogel that conforms and adheres to the tissues to which it is applied.
The subjects randomized to the Control group received standard good surgical care, excluding any use of anti-adhesion products.
Overall Number of Participants Analyzed 8 5
Mean (Standard Deviation)
Unit of Measure: cm^2
2.19  (2.32) 2.7  (5.24)
Time Frame 10 November 2008 (first subject consented) to 09 May 2009 (last subject follow-up visit date)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title SprayShield™ Control
Hide Arm/Group Description The SprayShield™ is a synthetic, sprayable polyethylene glycol (PEG) based absorbable gel adhesion barrier, that consists of two liquids that when mixed together rapidly cross-link to form a biocompatible absorbable flexible hydrogel that conforms and adheres to the tissues to which it is applied. The subjects randomized to the Control group received standard good surgical care, excluding any use of anti-adhesion products.
All-Cause Mortality
SprayShield™ Control
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
SprayShield™ Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/9 (0.00%)      1/6 (16.67%)    
Nervous system disorders     
Epilepsy  1  0/9 (0.00%)  0 1/6 (16.67%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (11.1)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
SprayShield™ Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/9 (0.00%)      0/6 (0.00%)    
The very small sample size makes it difficult to detect any real differences between the treatments, if such differences exist.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Director, Medical Affairs
Organization: Integra LifeSciences
Phone: 609-275-0500
Layout table for additonal information
Responsible Party: Integra LifeSciences Corporation
ClinicalTrials.gov Identifier: NCT00891657    
Other Study ID Numbers: GYN-08-002
First Submitted: April 30, 2009
First Posted: May 1, 2009
Results First Submitted: July 13, 2010
Results First Posted: August 31, 2010
Last Update Posted: September 7, 2017