HerniaPhase 4StARNCT01083472
Repair of Challenging Abdominal Wall Defects: Strattice(TM) TM in Abdominal Wall Repair (StAR)
A Phase 4 study testing Strattice(TM) Reconstructive Tissue Matrix and Suture/suture with absorbable mesh in people with Hernia and Surgical Wound Dehiscence, run by LifeCell at 29 sites in 6 countries.
Trial summary
The objective of this study is to compare the incidence of post-repair wound related complications, including hernia occurrence/recurrence, between challenging abdominal wall defects repaired with Strattice(TM) Reconstructive Tissue Matrix (TM) and those managed by standard repair. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hernia, Surgical Wound Dehiscence
- What is being tested?
- Strattice(TM) Reconstructive Tissue Matrix and Suture/suture with absorbable mesh
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 29 sitesin 6 countries
- Study dates
- Mar 2010to Jun 2012
- Phase
- Phase 4
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adults (18years of age or older) who is able to provide written informed consent for study participation
- has need of surgical intervention for repair of (potentially) contaminated abdominal wall defect of >3cm and <22cm in length, where the viscera have not been exposed for more than 15 days in case of open abdomen(skin and fascia open).
- Is willing and able to return for all scheduled \& required study visit.
Who cannot join
- severe systemic sepsis
- frank pus in the wound, a fistula that will not be closed at the time of surgery or intra-abdominal abscess in surgical area,
- ongoing necrotizing pancreatitis,
- Is on chronic immunosuppressive therapy, or other medication that influences wound healing
- requires only short-term temporary closure,
- requires a synthetic, non-absorbable mesh to close the abdominal wall defect
Show all 9Show fewer
- is unable to undergo general anesthesia,
- has other major organ system dysfunction or disorder that would jeopardize subject completing the 24 month study.
- Is unable to undergo an MRI scan
Trial locations and contacts
29 sites in 6 countries.
29 sites in 6 countries
Germany16 sites
Universitätsklinikum Aachen
Aachen
Unfallkrankenhaus Berlin
Berlin
St. Josef-Hospital
Bochum
Kliniken der Stadt Köln
Cologne
Universitätsklinikum Düsseldorf
Düsseldorf
Klinikum und Fachbereich Medizin der Johann Wolfgang Goethe Universitat
Frankfurt am Main
Universitätsklinikum Giessen und Marburg GmbH
Giessen
Universitatsklinikum Hamburg-Eppendorf
Hamburg
Krankenhaus Agatharied GmbH
Hausham
Krankenhaus Salem der Evang. Stadtmission Heidelberg
Heidelberg
Universitatsklinikum Heidelberg
Heidelberg
Klinikum Konstanz
Konstanz
LMU Klinikum der Universität München
München
Technischen Universität München - Klinikum rechts der Isar
München
Lukaskrankenhaus
Neuss
Klinikum St Elisabeth Straubing GmbH
Straubing
United Kingdom5 sites
Sandwell General Hospital
Birmingham
Raigmore Hospital
Inverness
Manchester Royal Infirmary
Manchester
Heart of England NHS Trust
Solihull
Arrowe Park Hospital
Upton, Wirral
France3 sites
CHU Amiens Hopital Nord
Amiens
Hopital de la Pitie-Salpetriere
Paris
CHU Robert Debre
Reims
Netherlands3 sites
Academisch Ziekenhuis Maastrict
Maastricht
Erasmus Medisch Centrum
Rotterdam
Haga Ziekenhuis
The Hague
About this study
Official title: A Multicenter, Prospective, Single-Blind, Randomized, Controlled Study of the Repair of Challenging Abdominal Wall Defects: Strattice(TM) TM in Abdominal Wall Repair
The objective of this study is to compare the incidence of post-repair wound related complications, including hernia occurrence/recurrence, between challenging abdominal wall defects repaired with Strattice(TM) Reconstructive Tissue Matrix (TM) and those managed by standard repair. It is hypothesized that the use of Strattice(TM) TM to reinforce the repair will reduce the incidence of these post-repair complications.
Read the detailed description
This is a prospective, multicenter, single-blind, randomized, longitudinal, cross-over evaluation of the repair of challenging abdominal wall defects using Strattice(TM) TM or standard surgical repair. These abdominal wall defects can be acute or chronic, and include midline, transverse (including flank) as well as Pfannenstiel incisions. The skin may be closed (fascial dehiscence or incisional hernia) or open (patient with open abdomen or acute fascial dehiscence) with or without evisceration. Patients randomized to the control group who require a re-operation to perform the planned final repair or due to failure of the initial repair within 12 months, will be offered repair with Strattice™ TM (i.e. "crossed over") or if such repair not performed, the patient will have completed the study. An adaptive study design will be used to validate the initial conditional power of the study and a balanced randomization, based upon the three conditions (type of defect [dehiscence, hernia repair or open abdomen], morbidity [POSSUM score] and time since exposure of abdominal fascia/viscera) will be used to equally distribute subjects between groups.
The primary endpoint of this study is hernia occurrence at 12 months post repair and secondary endpoints include re-operation for abdominal wall repair within 12 months, incidence of complications requiring intervention(medical or surgical) within the first 30 days after repair,, length of hospitalization and resource utilization, and all cause mortality.
Subjects will be enrolled and randomized to receive Strattice(TM) TM reinforcement of repair or standard of care repair (i.e. suture alone or suture with absorbable mesh) and followed at set timepoints to observe incision site repair for surgical site events, including reoperation and hernia occurrence.
- Conditions
- Hernia, Surgical Wound Dehiscence
- Being tested
- Strattice(TM) Reconstructive Tissue Matrix, Suture/suture with absorbable mesh
- Keywords
- dehiscence, laparotomy, Hernia repair, surgical wound, surgical mesh
- Medical subject headings
- Hernia, Surgical Wound Dehiscence, Surgical Wound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strattice(TM) Reconstructive Tissue MatrixDevice
Strattice(TM) TM will be used to support the repair of abdominal wall defect
Suture/suture with absorbable meshProcedure or surgery
Abdominal wall defect will be repaired with suture alone or absorbable mesh with suture
| Study group | Role | What they receive |
|---|---|---|
| Strattice(TM) TM repair | Active comparator | Strattice(TM) TM will be placed in the intraperitoneal or retrorectus position to support the repair of abdominal wall defect Receives: Device: Strattice(TM) Reconstructive Tissue Matrix |
| Standard of Care repair | Active comparator | Abdominal wall defect will be repaired using current standard of care techniques of either suture alone or suture with absorbable surgical mesh Receives: Procedure: Suture/suture with absorbable mesh |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hernia Occurrence
Hernia occurrence will be assessed by clinical evaluation. At Month 12 and at any time during the study if hernia occurrence is clinically suspected, a magnetic resonance image (MRI) will be obtained.
Measured: Month 12 after repair
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2010 (estimated)
- Study startMar 2010
- Primary completionJun 2012
- Study completionJun 2012
Why it stopped: Surgical practice evolution changed acceptable standard of care and lead to potential enrollment bias.
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 (5)Papers the sponsor has linked to this study.
- Other trials for HerniaStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- LifeCell
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Angus JM Watson, Principal investigator, Raigmore Hospital, Inverness Scotland, National Health Service, UKBerndt Reith, Principal investigator, Klinikum Konstanz, Konstanz GermanyJohannes Jeekel, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01083472
- Sponsor's protocol ID
- LFC2009.01.01
- Acronym
- StAR
- Status last verified
- Sep 2013
- First submitted
- 8 Mar 2010
- Last updated
- 19 Nov 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Van Geldere D. One hundred years of abdominal wound dehiscence and nothing has changed. Hernia 2000; 4:302-4.
van't RM, De Vos Van Steenwijk PJ, Bonjer HJ, Steyerberg EW, Jeekel J. Incisional hernia after repair of wound dehiscence: incidence and risk factors. Am Surg. 2004 Apr;70(4):281-6.
PubMed 15098775Murugappan K, Gomes F, Waxman B. Abdominal wound dehiscence - who is really at risk? ANZ J Surg 2009; 79(S1):A25
Gislason H, Viste A. Closure of burst abdomen after major gastrointestinal operations--comparison of different surgical techniques and later development of incisional hernia. Eur J Surg. 1999 Oct;165(10):958-61. doi: 10.1080/110241599750008071.
PubMed 10574104Webster C, Neumayer L, Smout R, Horn S, Daley J, Henderson W, Khuri S; National Veterans Affairs Surgical Quality Improvement Program. Prognostic models of abdominal wound dehiscence after laparotomy. J Surg Res. 2003 Feb;109(2):130-7. doi: 10.1016/s0022-4804(02)00097-5.
PubMed 12643854
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective, Single-Blind, Randomized, Controlled Study of the Repair of Challenging Abdominal Wall Defects: Strattice(TM) TM in Abdominal Wall Repair
- ClinicalTrials.gov ID
- NCT01083472
- Acronym / sponsor ID
- StAR / LFC2009.01.01
- Conditions
- Hernia, Surgical Wound Dehiscence
- Keywords
- dehiscence, laparotomy, Hernia repair, surgical wound, surgical mesh
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Surgical practice evolution changed acceptable standard of care and lead to potential enrollment bias.
- Enrolment
- 37 participants (actual)
- Lead sponsor
- LifeCellIndustry (pharma, biotech, devices)
- Study start
- Mar 2010
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 9 Mar 2010 (estimated)
- Results
- Posted 19 Nov 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to compare the incidence of post-repair wound related complications, including hernia occurrence/recurrence, between challenging abdominal wall defects repaired with Strattice(TM) Reconstructive Tissue Matrix (TM) and those managed by standard repair. It is hypothesized that the use of Strattice(TM) TM to reinforce the repair will reduce the incidence of these post-repair complications.
Detailed description
This is a prospective, multicenter, single-blind, randomized, longitudinal, cross-over evaluation of the repair of challenging abdominal wall defects using Strattice(TM) TM or standard surgical repair. These abdominal wall defects can be acute or chronic, and include midline, transverse (including flank) as well as Pfannenstiel incisions. The skin may be closed (fascial dehiscence or incisional hernia) or open (patient with open abdomen or acute fascial dehiscence) with or without evisceration. Patients randomized to the control group who require a re-operation to perform the planned final repair or due to failure of the initial repair within 12 months, will be offered repair with Strattice™ TM (i.e. "crossed over") or if such repair not performed, the patient will have completed the study. An adaptive study design will be used to validate the initial conditional power of the study and a balanced randomization, based upon the three conditions (type of defect [dehiscence, hernia repair or open abdomen], morbidity [POSSUM score] and time since exposure of abdominal fascia/viscera) will be used to equally distribute subjects between groups.
The primary endpoint of this study is hernia occurrence at 12 months post repair and secondary endpoints include re-operation for abdominal wall repair within 12 months, incidence of complications requiring intervention(medical or surgical) within the first 30 days after repair,, length of hospitalization and resource utilization, and all cause mortality.
Subjects will be enrolled and randomized to receive Strattice(TM) TM reinforcement of repair or standard of care repair (i.e. suture alone or suture with absorbable mesh) and followed at set timepoints to observe incision site repair for surgical site events, including reoperation and hernia occurrence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Strattice(TM) TM repair | Active comparator | Device: Strattice(TM) Reconstructive Tissue MatrixStrattice(TM) TM will be placed in the intraperitoneal or retrorectus position to support the repair of abdominal wall defect |
| Standard of Care repair | Active comparator | Procedure: Suture/suture with absorbable meshAbdominal wall defect will be repaired using current standard of care techniques of either suture alone or suture with absorbable surgical mesh |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- adults (18years of age or older) who is able to provide written informed consent for study participation
- has need of surgical intervention for repair of (potentially) contaminated abdominal wall defect of >3cm and <22cm in length, where the viscera have not been exposed for more than 15 days in case of open abdomen(skin and fascia open).
- Is willing and able to return for all scheduled \& required study visit.
Key exclusion criteria (9 listed)
- severe systemic sepsis
- frank pus in the wound, a fistula that will not be closed at the time of surgery or intra-abdominal abscess in surgical area,
- ongoing necrotizing pancreatitis,
- Is on chronic immunosuppressive therapy, or other medication that influences wound healing
- requires only short-term temporary closure,
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 |
|---|---|---|
| Strattice(TM) Reconstructive Tissue MatrixStrattice(TM) TM will be used to support the repair of abdominal wall defect | Device | Strattice(TM) TM repair |
| Suture/suture with absorbable meshAbdominal wall defect will be repaired with suture alone or absorbable mesh with suture | Procedure or surgery | Standard of Care repair |
Primary outcome
Hernia Occurrence
Time frame: Month 12 after repair
Hernia occurrence will be assessed by clinical evaluation. At Month 12 and at any time during the study if hernia occurrence is clinically suspected, a magnetic resonance image (MRI) will be obtained.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BackgroundVan Geldere D. One hundred years of abdominal wound dehiscence and nothing has changed. Hernia 2000; 4:302-4.
- Background: PubMed 15098775van't RM, De Vos Van Steenwijk PJ, Bonjer HJ, Steyerberg EW, Jeekel J. Incisional hernia after repair of wound dehiscence: incidence and risk factors. Am Surg. 2004 Apr;70(4):281-6.
- BackgroundMurugappan K, Gomes F, Waxman B. Abdominal wound dehiscence - who is really at risk? ANZ J Surg 2009; 79(S1):A25
- Background: PubMed 10574104Gislason H, Viste A. Closure of burst abdomen after major gastrointestinal operations--comparison of different surgical techniques and later development of incisional hernia. Eur J Surg. 1999 Oct;165(10):958-61. doi: 10.1080/110241599750008071.
- Background: PubMed 12643854Webster C, Neumayer L, Smout R, Horn S, Daley J, Henderson W, Khuri S; National Veterans Affairs Surgical Quality Improvement Program. Prognostic models of abdominal wound dehiscence after laparotomy. J Surg Res. 2003 Feb;109(2):130-7. doi: 10.1016/s0022-4804(02)00097-5.
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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.
Angus JM Watson principal investigator
Raigmore Hospital, Inverness Scotland, National Health Service, UK
Berndt Reith principal investigator
Klinikum Konstanz, Konstanz Germany
Johannes Jeekel study chair
29 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Strattice(TM) Reconstructive Tissue Matrix and Suture/suture with absorbable mesh in people with Hernia and Surgical Wound Dehiscence, run by LifeCell at 29 sites in 6 countries.
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 9 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: stopped early, as of the sponsor's last update on 19 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in Germany, United Kingdom, France, Netherlands, Italy and 1 more country. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 19 Nov 2013). 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?
Hernia Occurrence (time frame: Month 12 after repair). 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 NCT01083472, which also lists 5 linked publications.
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 19 Nov 2013.