Post Market Study for an Adhesion Barrier Following Laparoscopic Myomectomy

• Sponsor: Integra LifeSciences Corporation (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00891657
• Collaborator: (none)
• Enrollment: 15
• Location: 1
• Arms: 2
• Duration (Months): 5.9
• Patients Per Site Per Month: 2.5

Study Details

Study Description

Brief Summary

This study is planned as a prospective, randomised, parallel, controlled, multi-centre, open label, comparative evaluation of SprayShield™ Adhesion Barrier plus good surgical technique, versus good surgical technique alone, with a blinded, third party video evaluation of adhesion formation at second look laparoscopy (SLL) following laparoscopic myomectomy.

Condition or Disease	Intervention/Treatment	Phase
Fibroid; Myoma; Leiomyoma	Device: SprayShield™	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 15 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Prevention
• Official Title: A Randomised, Prospective, Multi-Centre Clinical Study of SprayShield™ Adhesion Barrier System as a Barrier for the Prevention of Adhesion Formation After Laparoscopic Myomectomy
• Study Start Date: Nov 1, 2008
• Actual Primary Completion Date: May 1, 2009
• Actual Study Completion Date: May 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SprayShield™ SprayShield™	Device: SprayShield™; Anti-adhesion barrier
No Intervention: Control No adhesion barrier administered.

Outcome Measures

Primary Outcome Measures

1. Number of Sites Adherent to the Uterus [8-12 weeks post myomectomy]

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

2. Mean Severity Score of Sites Adherent to the Uterus [8-12 weeks post myomectomy]

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

3. Mean Extent Score of Sites Adherent to the Uterus [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.

4. Area of Sites Adherent to the Uterus (cm^2) [8-12 weeks post myomectomy]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Females, 18 years of age or older, of child-bearing potential.

• Subject has at least one myoma >= 3 cm.

Exclusion Criteria:

• Pregnant or lactating females.

• Females undergoing prior open or closed myomectomy for treatment of myomas.

• Evidence of current active endometriosis or infection

• History of or active inflammatory bowel disease or pelvic inflammatory disease.

• Presence of a frozen pelvis, or hydrosalpinges.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pius Clinic	Oldenburg		Germany

Sponsors and Collaborators

• Integra LifeSciences Corporation

Investigators

• Principal Investigator: Rudy Leon De Wilde, MD, Pius Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Integra LifeSciences Corporation
• ClinicalTrials.gov Identifier: NCT00891657
• Other Study ID Numbers: GYN-08-002
• First Posted: May 1, 2009
• Last Update Posted: Sep 7, 2017
• Last Verified: Aug 1, 2017

• Keywords provided by Integra LifeSciences Corporation: Adhesion; Fibroid; Myoma; Leiomyoma; Myomectomy
• Additional relevant MeSH terms: Leiomyoma; Myofibroma; Tissue Adhesions

Study Results

Participant Flow

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.

Arm/Group Title	SprayShield™	Control
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

Baseline Characteristics

Arm/Group Title	SprayShield™	Control	Total
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 Participants	9	6	15
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	9 100%	6 100%	15 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	35.8 (4.6)	44.3 (3.3)	39.2 (5.9)
Sex: Female, Male (Count of Participants)
Female	9 100%	6 100%	15 100%
Male	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
Germany	9 100%	6 100%	15 100%

Outcome Measures

1. Primary Outcome

Title	Number of Sites Adherent to the Uterus
Description	The number of times an adhesion is attached to the uterus.
Time Frame	8-12 weeks post myomectomy

Outcome Measure Data

Analysis Population Description

Number of subjects to have had a second laparoscopic look.

Arm/Group Title	SprayShield™	Control
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.
Measure Participants	8	5
Mean (Standard Deviation) [Adhesion Sites]	1.1 (1.0)	0.6 (0.9)

2. Primary Outcome

Title	Mean Severity Score of Sites Adherent to the Uterus
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

Outcome Measure Data

Analysis Population Description

Number of subjects to have had a second laparoscopic look.

Arm/Group Title	SprayShield™	Control
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.
Measure Participants	8	5
Mean (Standard Deviation) [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
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	SprayShield™	Control
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.
Measure Participants	8	5
Mean (Standard Deviation) [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)
Time Frame	8-12 weeks post myomectomy

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	SprayShield™	Control
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.
Measure Participants	8	5
Mean (Standard Deviation) [cm^2]	2.19 (2.32)	2.7 (5.24)

Adverse Events

Time Frame	10 November 2008 (first subject consented) to 09 May 2009 (last subject follow-up visit date)
Arm/Group Title	SprayShield™		Control
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 (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	SprayShield™		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/9 (0%)		1/6 (16.7%)
Nervous system disorders
Epilepsy	0/9 (0%)	0	1/6 (16.7%)	1
Other (Not Including Serious) Adverse Events
	SprayShield™		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/9 (0%)		0/6 (0%)

Limitations/Caveats

The very small sample size makes it difficult to detect any real differences between the treatments, if such differences exist.

More Information

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.