Fibroid, Leiomyoma, Myoma
Conditions
Keywords
Adhesion, Fibroid, Myoma, Leiomyoma, Myomectomy
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.
Interventions
DEVICESprayShield™
Anti-adhesion barrier
Sponsors
Integra LifeSciences Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Sites Adherent to the Uterus | 8-12 weeks post myomectomy | The number of times an adhesion is attached to the uterus. |
| 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. |
| 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. |
| Area of Sites Adherent to the Uterus (cm^2) | 8-12 weeks post myomectomy | — |
Countries
Germany
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 9 |
| Control The subjects randomized to the Control group received standard good surgical care, excluding any use of anti-adhesion products. | 6 |
| Total | 15 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | Control | SprayShield™ | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants | 9 Participants | 15 Participants |
| Age, Continuous | 44.3 years STANDARD_DEVIATION 3.3 | 35.8 years STANDARD_DEVIATION 4.6 | 39.2 years STANDARD_DEVIATION 5.9 |
| Region of Enrollment Germany | 6 participants | 9 participants | 15 participants |
| Sex: Female, Male Female | 6 Participants | 9 Participants | 15 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 9 | 0 / 6 |
| serious Total, serious adverse events | 0 / 9 | 1 / 6 |
Outcome results
Primary
Area of Sites Adherent to the Uterus (cm^2)
Time frame: 8-12 weeks post myomectomy
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SprayShield™ | Area of Sites Adherent to the Uterus (cm^2) | 2.19 cm^2 | Standard Deviation 2.32 |
| Control | Area of Sites Adherent to the Uterus (cm^2) | 2.7 cm^2 | Standard Deviation 5.24 |
Primary
Mean Extent Score of Sites Adherent to the Uterus
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SprayShield™ | Mean Extent Score of Sites Adherent to the Uterus | 0.92 Scores on a Scale | Standard Deviation 0.66 |
| Control | Mean Extent Score of Sites Adherent to the Uterus | 0.6 Scores on a Scale | Standard Deviation 0.89 |
Primary
Mean Severity Score of Sites Adherent to the Uterus
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
Population: Number of subjects to have had a second laparoscopic look.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SprayShield™ | Mean Severity Score of Sites Adherent to the Uterus | 1.63 Scores on a Scale | Standard Deviation 1.06 |
| Control | Mean Severity Score of Sites Adherent to the Uterus | 0.8 Scores on a Scale | Standard Deviation 1.1 |
Primary
Number of Sites Adherent to the Uterus
The number of times an adhesion is attached to the uterus.
Time frame: 8-12 weeks post myomectomy
Population: Number of subjects to have had a second laparoscopic look.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SprayShield™ | Number of Sites Adherent to the Uterus | 1.1 Adhesion Sites | Standard Deviation 1 |
| Control | Number of Sites Adherent to the Uterus | 0.6 Adhesion Sites | Standard Deviation 0.9 |