Safety Study of Polylactide-Caprolactone-Trimethylenecarb... | NCT00597662

Studies
Safety Study of Polylactide-Caprolactone-Trimethylenecarbonate Copolymer for Post-Operative Adhesion Prophylaxis

NCT00597662

Sponsor

University Hospital Tuebingen

Status

Completed

Last Update Posted

Jun 10, 2008Estimated

Enrollment

30Estimated

Phase

Phase 1

Conditions

Adhesions

Interventions

polylactide-caprolactone-trimethylenecarbonate copolymer
Icodextrin 4%

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2008

Primary Completion Date

Apr 2008Actual

Completion Date

Not provided

First Submitted Date

Jan 9, 2008

First Submission Date that Met QC Criteria

Jan 17, 2008

First Posted Date

Jan 18, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 9, 2008

Last Update Posted Date

Jun 10, 2008Estimated

Description Module

Brief Summary

The purpose of this study is to compare adhesion prophylaxis with polylactide-caprolactone-trimethylenecarbonate copolymer to icodextrin 4% in terms of safety, side effects and usability in addition to gaining early evidence of the effectiveness of polylactide-caprolactone-trimethylenecarbonate copolymer.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental		Device: polylactide-caprolactone-trimethylenecarbonate copolymer
2	Active Comparator		Device: Icodextrin 4%

Interventions

Name	Type	Description	Arm Group Labels	Other Names
polylactide-caprolactone-trimethylenecarbonate copolymer	Device	Polylactide-caprolactone-trimethylenecarbonate copolymer membrane is applied directly over the surgical scar on the visceral peritoneum

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Difference in visual analogue pain score on visit 8 after discharge minus visit 1 on admission		3 months

Secondary Outcomes

Measure	Description	Time Frame
Use of analgesia		1, 2 and 3 days
Post-operative pyrexia		3 months
Post-operative infection

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age 18-60 years
sex female
laparoscopic myomectomy indicated
ability and intention to conform to the study protocol
written informed consent

Exclusion Criteria:

pregnancy
indication for laparotomy
inflammatory bowel disease
additional surgical interventions
known or suspected intollerance or hypersensibility to the interventions
chronic pain
systemic corticoids or irradiation
alcohol abuse or other substance abuse
clinical signs of malignancy
psychiatric or neurological disease
participation in another clinical trial within 30 days
inability to understand the purpose of the trial or to conform to the study protocol
absence of written informed consent
inflammation of pelvic organs
presence of adhesions which lead to a conversion from laparoscopy to laparotomy
concurrent therapy with corticoids, anti-neoplastic agents or irradiation
maintenance therapy with non-steroidal anti-inflammatory drugs or analgesics

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Diethelm Wallwiener, Prof. Dr.	Universitäts-Frauenklinik Tübingen	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Universitäts-Frauenklinik Tübingen		Tübingen	Baden-Wurttemberg	72076	Germany

Condition Browse Module

MeSH Terms

ID	Term
D000267	Tissue Adhesions

Ancestor Terms

ID	Term
D002921	Cicatrix
D005355	Fibrosis
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided