HerniorrhaphyPhase 2NCT01220024
Safety and Efficacy of CollaRx® Bupivacaine Implant in Men After Open Laparotomy Herniorrhaphy
A Phase 2 study testing Bupivacaine Collagen Sponge in people with Herniorrhaphy and Postoperative Pain, run by Innocoll at 1 site in United States.
Trial summary
This study will assess pain intensity for the first 72 hrs after after aggravated movement (cough)following open laparotomy inguinal herniorrhaphy in patient who receive either the CollaRx Bupivacaine implant or a plain collagen sponge. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Herniorrhaphy, Postoperative Pain, Inguinal Hernia
- What is being tested?
- Bupivacaine Collagen Sponge
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Dec 2010to 18 May 2011
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Man ≥ 18 years
- Body mass index (BMI) ≥ 19 and ≤ 40 kg/m2.
- Has a planned unilateral inguinal herniorrhaphy (open laparotomy, tension free technique) to be performed according to standard surgical technique under general anesthesia.
Who cannot join
- Has a known hypersensitivity to amide local anesthetics, opioids, or bovine products.
- Scheduled for bilateral inguinal herniorrhaphy.
- Undergone a prior herniorrhaphy on the side scheduled for repair.
- Undergone major surgery within 3 mos of the scheduled herniorrhaphy.
- Has cardiac arrhythmias or atrioventricular (AV) conduction disorders.
- Concomitantly uses antiarrhythmics (eg, amiodarone, lidocaine), propranolol, or strong/moderate cytochrome P450 (CYP) 3A4 inhibitors or inducers (eg, macrolide antibiotics and grapefruit juice).
- Used long acting analgesics within 24 hours of surgery. Short acting analgesics such as acetaminophen may be used on the day of surgery but are subject to preoperative restrictions for oral intake.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II, Randomized, Single Dose, Double-blind, Placebo Controlled Study to Investigate the Efficacy and Safety Profile of the CollaRx® Bupivacaine Implant (200 mg Bupivacaine Hydrochloride) in Men After Open Laparotomy Herniorrhaphy
This study will assess pain intensity for the first 72 hrs after after aggravated movement (cough)following open laparotomy inguinal herniorrhaphy in patient who receive either the CollaRx Bupivacaine implant or a plain collagen sponge.
Read the detailed description
Inguinal herniorrhaphy is a common surgery; and common surgical methods used include laparoscopic and open placement of synthetic mesh. The use of synthetic mesh can greatly reduce the risk of hernia recurrence regardless of the method used for its placement. Managing postoperative pain and preventing morbidity after open mesh herniorrhaphy remain considerable medical challenges.
Bupivacaine is a local anesthetic (pain medicine) that has an established safety profile. Collagen is a protein that is found in all mammals. The CollaRx Bupivacaine implant is a thin flat sponge made out of collagen that comes from cow tendons and contains bupivacaine. When inserted into a surgical site, the collagen breaks down and bupivacaine is released at the site but very little is absorbed into the blood stream. The high levels of bupivacaine at the surgical site may result in less pain for several days after surgery.
This study will assess pain intensity after surgery in patients who receive either the CollaRx Bupivacaine implant or a plain collagen sponge.
- Conditions
- Herniorrhaphy, Postoperative Pain, Inguinal Hernia
- Being tested
- Bupivacaine Collagen Sponge, Placebo collagen Sponge
- Medical subject headings
- Pain, Postoperative, Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine Collagen SpongeDrug
Also called Bupivacaine Implant
Drug: Bupivacaine Collagen Sponge
Placebo collagen SpongeDrug
Also called Collagen Implant
Drug: Placebo Collagen Sponge
| Study group | Role | What they receive |
|---|---|---|
| 2, 5x5cm bupivacaine collagen sponges | Experimental | collagen sponges Receives: Drug: Bupivacaine Collagen Sponge |
| 2, Placebo collagen sponges | Placebo comparator | Placebo collagen sponges Receives: Drug: Placebo collagen Sponge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sum of Pain Intensity Defined as Area Under the Curve (AUC) of 100-mm VAS PI Scores.
The primary efficacy variable was SPI defined as area under the curve (AUC) of 100-mm VAS pain intensity scores after aggravated movement (cough) from 1 to 72 hours after surgery. Minimum score is "0". Maximum score is 7200. This represents the AUC (Area Under the Curve) of the pain intensities when calculated with the trapezoidal rule. A lower score means a better outcome or less pain reported.
Measured: 1, 2, 4, 6, 8, 10, 12, 24, 48, and 72 hours.
Secondary outcomes (5)
Sum of Pain Intensity (SPI) After Aggravated Movement (Cough)
Measured on a Visual Analog Pain Scale (VAS) with the lowest possible value of 0 and highest 100 (0 - 100) at each time point. A lower score is better which means the patient experience lower pain. The score is calculated using the number of hours * the VAS score. This represents the AUC (Area Under the Curve) of the pain intensities when calculated with the trapezoidal rule. For each measure outcome - the minimum score is "0" and the maximum score is 100* the number of hours in that period.
Measured: 1, 2, 4, 6, 8, 10, 12, 24, 48, and 72 hours.
Sum of Pain Intensity (SPI) Using a Visual Analog Scale (VAS) When at Rest
Measured on a Visual Analog Pain Scale (VAS) with the lowest possible value of 0 and highest 100 (0 - 100) at each time point. A lower score is better which means the patient experience lower pain. The score is calculated using the number of hours * the VAS score. This represents the AUC (Area Under the Curve) of the pain intensities when calculated with the trapezoidal rule. For each measure outcome - the minimum score is "0" and the maximum score is 100* the number of hours in that period.
Measured: 1, 2, 4, 6, 8, 10, 12, 24, 48, and 72 hours.
Pain Intensity Visual Analog Pain Scale Scores Over Time After Aggravated Movement (Cough)
Measured on a Visual Analog Pain Scale (VAS) with the lowest possible value of 0 and highest 100 (0 - 100). Patients were asked during multiple time points to provide a score on this VAS scale. The lower the sore the better the outcome. Higher score is a worse outcome
Measured: 1,2,4,6,8,10,12,24,48 and 72 hours
Pain Intensity VAS Scores Over Time at Rest
Measured on a Visual Analog Pain Scale (VAS) with the lowest possible value of 0 and highest 100 (0 - 100). Patients were asked during multiple time points to provide a score on this VAS scale. Lower score is better. Higher score means more pain. Time points are summarized independently
Measured: 1,2,4,6,8,10,12,24,48 and 72 hours
Mean Sum of Pain Intensity (SPI) Categorical Scores After Aggravated Movement
Measured on a Visual Analog Pain Scale (VAS) with the lowest possible value of 0 and highest 100 (0 - 100) for each timepoint. (timepoints 1,2,4,6,8,10,12,24,48 and 72 hours ) Patients were asked during multiple time points to provide a score on this VAS scale. For 1 to 24 hours the highest score possible would be 800. For 1 to 48 hours the highest score possible would be 900. For 1 to 72 hours the highest score possible would be 1000. A mean Lower score is better. A mean Higher score is a worse outcome.
Measured: 1,2,4,6,8,10,12,24,48 and 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2010 (estimated)
- Study start2 Dec 2010
- Primary completion18 May 2011
- Study completion18 May 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HerniorrhaphyStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Innocoll
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Premier Research
- Responsible party
- Sponsor
- Investigators
- David Prior, Study director, Innocoll
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01220024
- Sponsor's protocol ID
- INN-CB-010
- Status last verified
- Feb 2021
- First submitted
- 23 Sep 2010
- Last updated
- 10 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Cusack SL, Jaros M, Kuss M, Minkowitz HS, Winkle P, Hemsen L. Clinical evaluation of XaraColl((R)), a bupivacaine-collagen implant, for postoperative analgesia in two multicenter, randomized, double-blind, placebo-controlled pilot studies. J Pain Res. 2012;5:217-25. doi: 10.2147/JPR.S33453. Epub 2012 Jun 27.
PubMed 22792007
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Randomized, Single Dose, Double-blind, Placebo Controlled Study to Investigate the Efficacy and Safety Profile of the CollaRx® Bupivacaine Implant (200 mg Bupivacaine Hydrochloride) in Men After Open Laparotomy Herniorrhaphy
- ClinicalTrials.gov ID
- NCT01220024
- Acronym / sponsor ID
- INN-CB-010
- Conditions
- Herniorrhaphy, Postoperative Pain, Inguinal Hernia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- InnocollIndustry (pharma, biotech, devices)
- Collaborators
- Premier Research
- Study start
- 2 Dec 2010 (actual)
- Primary completion
- 18 May 2011 (actual)
- Study completion
- 18 May 2011 (actual)
- First posted
- 13 Oct 2010 (estimated)
- Results
- Posted 10 Mar 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will assess pain intensity for the first 72 hrs after after aggravated movement (cough)following open laparotomy inguinal herniorrhaphy in patient who receive either the CollaRx Bupivacaine implant or a plain collagen sponge.
Detailed description
Inguinal herniorrhaphy is a common surgery; and common surgical methods used include laparoscopic and open placement of synthetic mesh. The use of synthetic mesh can greatly reduce the risk of hernia recurrence regardless of the method used for its placement. Managing postoperative pain and preventing morbidity after open mesh herniorrhaphy remain considerable medical challenges.
Bupivacaine is a local anesthetic (pain medicine) that has an established safety profile. Collagen is a protein that is found in all mammals. The CollaRx Bupivacaine implant is a thin flat sponge made out of collagen that comes from cow tendons and contains bupivacaine. When inserted into a surgical site, the collagen breaks down and bupivacaine is released at the site but very little is absorbed into the blood stream. The high levels of bupivacaine at the surgical site may result in less pain for several days after surgery.
This study will assess pain intensity after surgery in patients who receive either the CollaRx Bupivacaine implant or a plain collagen sponge.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2, 5x5cm bupivacaine collagen sponges | Experimental | Drug: Bupivacaine Collagen Spongecollagen sponges |
| 2, Placebo collagen sponges | Placebo comparator | Drug: Placebo collagen SpongePlacebo collagen sponges |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Man ≥ 18 years
- Body mass index (BMI) ≥ 19 and ≤ 40 kg/m2.
- Has a planned unilateral inguinal herniorrhaphy (open laparotomy, tension free technique) to be performed according to standard surgical technique under general anesthesia.
Key exclusion criteria (7 listed)
- Has a known hypersensitivity to amide local anesthetics, opioids, or bovine products.
- Scheduled for bilateral inguinal herniorrhaphy.
- Undergone a prior herniorrhaphy on the side scheduled for repair.
- Undergone major surgery within 3 mos of the scheduled herniorrhaphy.
- Has cardiac arrhythmias or atrioventricular (AV) conduction disorders.
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 |
|---|---|---|
| Bupivacaine Collagen SpongeAlso: Bupivacaine ImplantDrug: Bupivacaine Collagen Sponge | Drug | 2, 5x5cm bupivacaine collagen sponges |
| Placebo collagen SpongeAlso: Collagen ImplantDrug: Placebo Collagen Sponge | Drug | 2, Placebo collagen sponges |
Primary outcome
Sum of Pain Intensity Defined as Area Under the Curve (AUC) of 100-mm VAS PI Scores.
Time frame: 1, 2, 4, 6, 8, 10, 12, 24, 48, and 72 hours.
The primary efficacy variable was SPI defined as area under the curve (AUC) of 100-mm VAS pain intensity scores after aggravated movement (cough) from 1 to 72 hours after surgery. Minimum score is "0". Maximum score is 7200. This represents the AUC (Area Under the Curve) of the pain intensities when calculated with the trapezoidal rule. A lower score means a better outcome or less pain reported.
5 secondary outcomes
Sum of Pain Intensity (SPI) After Aggravated Movement (Cough)
Time frame: 1, 2, 4, 6, 8, 10, 12, 24, 48, and 72 hours.
Sum of Pain Intensity (SPI) Using a Visual Analog Scale (VAS) When at Rest
Time frame: 1, 2, 4, 6, 8, 10, 12, 24, 48, and 72 hours.
Pain Intensity Visual Analog Pain Scale Scores Over Time After Aggravated Movement (Cough)
Time frame: 1,2,4,6,8,10,12,24,48 and 72 hours
Pain Intensity VAS Scores Over Time at Rest
Time frame: 1,2,4,6,8,10,12,24,48 and 72 hours
Mean Sum of Pain Intensity (SPI) Categorical Scores After Aggravated Movement
Time frame: 1,2,4,6,8,10,12,24,48 and 72 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 22792007Cusack SL, Jaros M, Kuss M, Minkowitz HS, Winkle P, Hemsen L. Clinical evaluation of XaraColl((R)), a bupivacaine-collagen implant, for postoperative analgesia in two multicenter, randomized, double-blind, placebo-controlled pilot studies. J Pain Res. 2012;5:217-25. doi: 10.2147/JPR.S33453. Epub 2012 Jun 27.
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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.
David Prior study director
Innocoll
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bupivacaine Collagen Sponge in people with Herniorrhaphy and Postoperative Pain, run by Innocoll at 1 site in United States.
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 3 inclusion and 7 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 Mar 2021. 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 United States. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Sum of Pain Intensity Defined as Area Under the Curve (AUC) of 100-mm VAS PI Scores. (time frame: 1, 2, 4, 6, 8, 10, 12, 24, 48, and 72 hours.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01220024, which also lists 1 linked publication.
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 Mar 2021; AzTrials last refreshed its copy on 8 Nov 2026.