AdhesionsPhase 1NCT00597662
Safety Study of Polylactide-Caprolactone-Trimethylenecarbonate Copolymer for Post-Operative Adhesion Prophylaxis
A Phase 1 study testing polylactide-caprolactone-trimethylenecarbonate copolymer and Icodextrin 4% in people with Adhesions, run by University Hospital Tuebingen at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Adhesions
- What is being tested?
- polylactide-caprolactone-trimethylenecarbonate copolymer and Icodextrin 4%
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2008to Apr 2008
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- age 18-60 years
- sex female
- laparoscopic myomectomy indicated
- ability and intention to conform to the study protocol
- written informed consent
Who cannot join
- pregnancy
- indication for laparotomy
- inflammatory bowel disease
- additional surgical interventions
- known or suspected intollerance or hypersensibility to the interventions
- chronic pain
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Universitäts-Frauenklinik Tübingen
Tübingen, Baden-Wurttemberg, 72076
About this study
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.
- Conditions
- Adhesions
- Being tested
- polylactide-caprolactone-trimethylenecarbonate copolymer, Icodextrin 4%
- Medical subject headings
- Tissue Adhesions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
polylactide-caprolactone-trimethylenecarbonate copolymerDevice
Polylactide-caprolactone-trimethylenecarbonate copolymer membrane is applied directly over the surgical scar on the visceral peritoneum
Icodextrin 4%Device
1 liter icodextrin 4% is instilled into the peritoneal cavity at the end of the operation
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Device: polylactide-caprolactone-trimethylenecarbonate copolymer |
| 2 | Active comparator | Not described Receives: Device: Icodextrin 4% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in visual analogue pain score on visit 8 after discharge minus visit 1 on admission
Measured: 3 months
Secondary outcomes (11)
Use of analgesia
Measured: 1, 2 and 3 days
Post-operative pyrexia
Measured: 3 months
Post-operative infection
Measured: 3 months
Requirement for re-operation
Measured: 3 months
Dysmenorrhoea
Measured: 3 months
Dyspareunia
Measured: 3 months
Constipation
Measured: 3 months
Diarrhoea
Measured: 3 months
Nausea
Measured: 3 months
Duration of adhesion prophylaxis
Measured: Day 1
Usability as assessed by surgeon
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2008 (estimated)
- Study startJan 2008
- Primary completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AdhesionsStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Investigators
- Diethelm Wallwiener, Prof. Dr., Study chair, Universitäts-Frauenklinik Tübingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00597662
- Sponsor's protocol ID
- SUP-002
- Status last verified
- Jun 2008
- First submitted
- 9 Jan 2008
- Last updated
- 10 Jun 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety Study of Polylactide-Caprolactone-Trimethylenecarbonate Copolymer for Post-Operative Adhesion Prophylaxis
- ClinicalTrials.gov ID
- NCT00597662
- Acronym / sponsor ID
- SUP-002
- Conditions
- Adhesions
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Apr 2008 (actual)
- First posted
- 18 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: polylactide-caprolactone-trimethylenecarbonate copolymer |
| 2 | Active comparator | Device: Icodextrin 4% |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- age 18-60 years
- sex female
- laparoscopic myomectomy indicated
- ability and intention to conform to the study protocol
- written informed consent
Key exclusion criteria (17 listed)
- pregnancy
- indication for laparotomy
- inflammatory bowel disease
- additional surgical interventions
- known or suspected intollerance or hypersensibility to the interventions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| polylactide-caprolactone-trimethylenecarbonate copolymerPolylactide-caprolactone-trimethylenecarbonate copolymer membrane is applied directly over the surgical scar on the visceral peritoneum | Device | 1 |
| Icodextrin 4%1 liter icodextrin 4% is instilled into the peritoneal cavity at the end of the operation | Device | 2 |
Primary outcome
Difference in visual analogue pain score on visit 8 after discharge minus visit 1 on admission
Time frame: 3 months
11 secondary outcomes
Use of analgesia
Time frame: 1, 2 and 3 days
Post-operative pyrexia
Time frame: 3 months
Post-operative infection
Time frame: 3 months
Requirement for re-operation
Time frame: 3 months
Dysmenorrhoea
Time frame: 3 months
Dyspareunia
Time frame: 3 months
Constipation
Time frame: 3 months
Diarrhoea
Time frame: 3 months
Nausea
Time frame: 3 months
Duration of adhesion prophylaxis
Time frame: Day 1
Usability as assessed by surgeon
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Diethelm Wallwiener, Prof. Dr. study chair
Universitäts-Frauenklinik Tübingen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing polylactide-caprolactone-trimethylenecarbonate copolymer and Icodextrin 4% in people with Adhesions, run by University Hospital Tuebingen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jun 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in visual analogue pain score on visit 8 after discharge minus visit 1 on admission (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2008.