Trial Outcomes & Findings for Post Market Study for an Adhesion Barrier Following Laparoscopic Myomectomy (NCT NCT00891657)

NCT ID: NCT00891657

Last Updated: 2017-09-07

Results Overview

The number of times an adhesion is attached to the uterus.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 15 participants
• Primary outcome timeframe: 8-12 weeks post myomectomy
• Results posted on: 2017-09-07

Participant Flow

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.

Participant milestones

Measure	SprayShield™ 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.	Control The subjects randomized to the Control group received standard good surgical care, excluding any use of anti-adhesion products.
Overall Study STARTED	9	6
Overall Study COMPLETED	8	5
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Measure	SprayShield™ 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.	Control The subjects randomized to the Control group received standard good surgical care, excluding any use of anti-adhesion products.
Overall Study Withdrawal by Subject	1	1

Baseline Characteristics

Post Market Study for an Adhesion Barrier Following Laparoscopic Myomectomy

Baseline characteristics by cohort

Measure	SprayShield™ n=9 Participants 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.	Control n=6 Participants The subjects randomized to the Control group received standard good surgical care, excluding any use of anti-adhesion products.	Total n=15 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=93 Participants	6 Participants n=4 Participants	15 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Continuous	35.8 years STANDARD_DEVIATION 4.6 • n=93 Participants	44.3 years STANDARD_DEVIATION 3.3 • n=4 Participants	39.2 years STANDARD_DEVIATION 5.9 • n=27 Participants
Sex: Female, Male Female	9 Participants n=93 Participants	6 Participants n=4 Participants	15 Participants n=27 Participants
Sex: Female, Male Male	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Region of Enrollment Germany	9 participants n=93 Participants	6 participants n=4 Participants	15 participants n=27 Participants

PRIMARY outcome

Timeframe: 8-12 weeks post myomectomy

Population: Number of subjects to have had a second laparoscopic look.

The number of times an adhesion is attached to the uterus.

Outcome measures

Measure	SprayShield™ n=8 Participants 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.	Control n=5 Participants The subjects randomized to the Control group received standard good surgical care, excluding any use of anti-adhesion products.
Number of Sites Adherent to the Uterus	1.1 Adhesion Sites Standard Deviation 1.0	0.6 Adhesion Sites Standard Deviation 0.9

PRIMARY outcome

Timeframe: 8-12 weeks post myomectomy

Population: Number of subjects to have had a second laparoscopic look.

The scoring for severity is as follows: 0=no adhesions, 1=filmy, avascular adhesions, 2=vascular and/or dense adhesions, and 3=cohesive adhesions.

Outcome measures

Measure	SprayShield™ n=8 Participants 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.	Control n=5 Participants The subjects randomized to the Control group received standard good surgical care, excluding any use of anti-adhesion products.
Mean Severity Score of Sites Adherent to the Uterus	1.63 Scores on a Scale Standard Deviation 1.06	0.8 Scores on a Scale Standard Deviation 1.1

PRIMARY outcome

Timeframe: 8-12 weeks post myomectomy

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.

Outcome measures

Measure	SprayShield™ n=8 Participants 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.	Control n=5 Participants The subjects randomized to the Control group received standard good surgical care, excluding any use of anti-adhesion products.
Mean Extent Score of Sites Adherent to the Uterus	0.92 Scores on a Scale Standard Deviation 0.66	0.6 Scores on a Scale Standard Deviation 0.89

PRIMARY outcome

Timeframe: 8-12 weeks post myomectomy

Outcome measures

Measure	SprayShield™ n=8 Participants 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.	Control n=5 Participants The subjects randomized to the Control group received standard good surgical care, excluding any use of anti-adhesion products.
Area of Sites Adherent to the Uterus (cm^2)	2.19 cm^2 Standard Deviation 2.32	2.7 cm^2 Standard Deviation 5.24

Adverse Events

SprayShield™

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	SprayShield™ n=9 participants at risk 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.	Control n=6 participants at risk The subjects randomized to the Control group received standard good surgical care, excluding any use of anti-adhesion products.
Nervous system disorders Epilepsy	0.00% 0/9 • 10 November 2008 (first subject consented) to 09 May 2009 (last subject follow-up visit date)	16.7% 1/6 • Number of events 1 • 10 November 2008 (first subject consented) to 09 May 2009 (last subject follow-up visit date)

Other adverse events

Adverse event data not reported

Additional Information

Director, Medical Affairs

Integra LifeSciences

Phone: 609-275-0500

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place