The Efficacy and Safety Study of a New Cross-linked Hyaluronan Hydrogel in the Reduction of Postsurgical Peritoneal Adhesions

Adhesions Clinical Trial

— BAP  

Official title:

The Efficacy and Safety of a New Cross-linked Hyaluronan Hydrogel in the Reduction of Postsurgical Adhesions After Laparoscopic Gynecological Surgery: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02166554
• Other study ID #: FNL-2011-05
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: June 13, 2014
• Last updated: June 16, 2014
• Start date: June 2011
• Est. completion date: April 2013

Study information

• Verified date: June 2014
• Source: BioRegen Biomedical (CHangzhou) Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study was to determine whether the new crosslinked hyaluronan hydrogel was safe to use, and was effective for the prevention/reduction of adhesion formation following gynecological surgery

Description:

Postsurgical adhesions are a common medical complication of gynecologic and pelvic surgeries, and are frequently associated with chronic or recurrent pelvic pain, intestinal obstruction and infertility. This randomized, controlled, multicenter, clinical study was designed to evaluate the safety and performance of the new crosslinked hyaluronan hydrogel versus the standard of care for the reduction of postoperative adhesions in subjects undergoing laparoscopic surgeries. Subjects were scheduled to return at 9 weeks after the initial surgical procedure. At that time, a second-look laparoscopy was performed for postsurgical adhesion assessment. Adhesions were graded using a modified American Fertility Society (mAFS) scoring system.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 216
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Female.

• Aged 18-45 years.

• Been scheduled for removal of myomas, ovary cysts, endometriotic cysts or adhesions.

• Been willing to comply with all aspects of the treatment and evaluation schedule.

• Agreed to a second-look laparoscopic procedure to assess and lyse any adhesions formed at 9 weeks following the primary surgery.

• Provided voluntary written informed consent.

Exclusion Criteria:

• Acute or severe infection.

• Autoimmune diseases such as diabetes etc.

• Abnormal liver/renal and cardiovascular function

• Abnormal blood coagulation

• Medical histories of peripheral vascular disease, alcohol or drug abuse, and mental illness.

• Known or suspected intolerance or hypersensitivity to hyaluronan or its derivatives.

• Concurrent use of systemic antiinflammatory drugs.

• Clinical evidence of cancer.

• Use of anticoagulant, fibrin glue, other thrombogenic agents, or any other anti-adhesion agent during the procedure.

• Concurrent peritoneal grafting or tubal implantation.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Adhesions
• Endometriotic Cysts
• Myomas
• Ovary Cysts
• Tissue Adhesions

Intervention

Other:
• Saline
On the day of initial surgery

Device:
• Cross-linked Hyaluronan Hydrogel
On the day of the initial surgery

Locations

Country	Name	City	State
China	Beijing Chao-Yang Hospital	Beijing	Beijing
China	Beijing Hospital	Beijing	Beijing
China	China-Japan Friendship Hospital	Beijing	Beijing
China	Peking University First Hospital	Beijing	Beijing
China	The Third Xiangya Hospital	Changsha	Hunan
China	Qilu Hospital	Jinan	Shandong
China	The Second Hospital of Hebei Medical University	Shijiazhuang	Hebei

Sponsors (1)

Lead Sponsor	Collaborator
BioRegen Biomedical (CHangzhou) Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The adhesion incidence under moderate/severe category	The patient percentage with modified American Fertility Society (mAFS) score (ovaries and tubes) more than 4 points.	9 weeks following primary laparoscopic gynecological surgery	No
Secondary	modified American Fertility Society (mAFS) score	modified American Fertility Society (mAFS) score of ovaries/tubes	9 weeks following primary laparoscopic gynecological surgery	No
Secondary	Adhesion extent	Adhesion extent of ovaries/tubes	9 weeks following primary laparoscopic gynecological surgery	No
Secondary	Adhesion severity	Adhesion severity of ovaries/tubes	9 weeks following primary laparoscopic gynecological surgery	No
Secondary	The adhesion incidence under moderate/severe category	The patient percentage with modified American Fertility Society (mAFS) score (throughout abdominopelvic cavity) more than 4 points.	9 weeks following primary laparoscopic gynecological surgery	No
Secondary	modified American Fertility Society (mAFS) score	modified American Fertility Society (mAFS) score (throughout abdominopelvic cavity)	9 weeks following primary laparoscopic gynecological surgery	No
Secondary	Adhesion extent	Adhesion extent (throughout abdominopelvic cavity)	9 weeks following primary laparoscopic gynecological surgery	No
Secondary	Adhesion severity	Adhesion severity (throughout abdominopelvic cavity)	9 weeks following primary laparoscopic gynecological surgery	No
Secondary	Adverse events	Safety evaluation was based on clinical laboratory tests, the type and severity of adverse events recorded throughout the study, etc.	Up to 9 weeks	Yes