Fascial ClosureNCT02145052
Optimal Method of Fascial Closure in High Risk Patients Undergoing Laparotomy
A study testing Continuous suture and Interrupted suture in people with Fascial Closure, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The primary objective of this study is to identify the optimal method of fascial closure of a laparotomy incision in high risk patients for intra-abdominal complications. The investigators hypothesize that interrupted closure is associated with decreased complication rates when compared with running/continuous… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fascial Closure
- What is being tested?
- Continuous suture and Interrupted suture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 388 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2008to Jul 2016
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Adult patients >18 years of age, undergoing urgent laparotomy, admitted to the Division of Trauma, Emergency Surgery, and Surgical Critical Care.
Who cannot join
- Pregnant patients
- All elective patients
- Patients with pre-morbid condition not expected to survive >48 hours
- Patients unable to communicate in English
- Patients with primary ventral hernia or recent (within 1 month) abdominal operation.
- Patients with mesh in place
- Trauma patients
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Optimal Method of Fascial Closure in High Risk Patients Undergoing Laparotomy: A Prospective Randomized Study
The primary objective of this study is to identify the optimal method of fascial closure of a laparotomy incision in high risk patients for intra-abdominal complications. The investigators hypothesize that interrupted closure is associated with decreased complication rates when compared with running/continuous closure. Secondary objectives are to determine the rate of dehiscence in continuous and interrupted suture technique, and to determine the rate of wound infection, hernia formation, and mortality associated with suture technique.
Read the detailed description
Secure wound closure is an essential requirement for an uncomplicated and expedient recovery after an abdominal operation. The incidence of dehiscence ranges from 0-6% in different patient series and the associated mortality rate ranges from 10-35% [1]. Median laparotomy is the most common technique of abdominal incisions because it is simple, provides adequate exposure, is rapid to open and usually blood sparing [2]. The two common methods of fascial closure are continuous and interrupted with absorbable or non-absorbable suture. There is little debate that there is no significant difference between the two types of suture material. However, there is an ongoing debate concerning the optimal technique for closure. Both closure techniques are considered standard of care at this time.
The best method of wound closure would be one that provides adequate tensile strength to the incision until the wound is healed, approximates the tissue in a way that normal healing mechanisms can occur under optimal circumstances, remains secure even in the presence of local or systemic infection, the suture material is well tolerated on a short and long term basis, and, finally, should be done with expediency.
Previous randomized controlled trials of abdominal fascial closure have failed to determine the best technique and ideal suture [3]. Fagniez et al. randomized 3135 patients to receive continuous or interrupted sutures and further stratified them according to the type of wound: clean, clean-contaminated, and contaminated. This study looked at all patients, elective and emergent, and there was no statistically significant difference in wound dehiscence between continuous and interrupted suture technique [4]. A similar conclusion for wound dehiscence was shown by Gislason et al. where they compared 599 adults with major GI operation who received continuous or interrupted sutures [5]. In another prospective randomized trial, 571 patients were compared for continuous vs. interrupted sutures; again the dehiscence rate was not significant between the two groups [1]. The common denominator in all of these trials was the inclusion of all patients, elective as well as emergent, undergoing a laparotomy. None of the trials have compared the suture technique for patients requiring emergency laparotomy with wound dehiscence as a primary outcome. Results of these studies were often conflicting and have left many surgeons uncertain about the ideal technique for abdominal fascial closure, leave alone patients undergoing emergency surgery.
There have been no prospective randomized trials that look at the optimal method of fascial closure in high risk patients undergoing laparotomy. Through this research study, the investigators aim to determine identify the optimal method of fascial closure (interrupted vs. running/continuous suture) of a laparotomy incision in high risk patients for intra-abdominal complications
- Conditions
- Fascial Closure
- Being tested
- Continuous suture, Interrupted suture
- Keywords
- Fascial closure, Interrupted suture, Running suture, Continuous suture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous sutureOther
A continuous suture is considered standard of care.
Interrupted sutureOther
Interrupted sutures are considered standard of care.
| Study group | Role | What they receive |
|---|---|---|
| Continuous suture | Active comparator | 0 non-looped PDS using a tapered needle starting at the superior and the inferior portions of the wound. Fascia is then approximated with at least 1cm distance from the edge of the fascia and 1cm advancement. The two sutures are then knotted in the center with 8 square knots. Receives: Other: Continuous suture |
| Interrupted Suture | Active comparator | Using a tapered needle, 0 non-looped PDS interrupted figure of eight suture 1cm from the edge and advancing 1cm between each suture. Receives: Other: Interrupted suture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dehiscence
Dehiscence will be defined as more than 1cm horizontal defect in the fascia along the suture lines.
Measured: 1 year
Secondary outcomes (3)
Wound infection
Surgical site infections must fulfill the following criteria:
- Must occur within 30 days of surgery.
- Must involve only the skin and subcutaneous tissue.
- Must involve at least one of the following: a) Purulent discharge from a superficial infection; b) Organisms isolated from aseptically obtained wound culture
- Must involve at least one of the following signs of infection: a) Pain or tenderness; b) Localized swelling; c) Redness or heat
Measured: 30 days
Incisional Hernia
Incisional hernia will be identified by following up patients at 6 months, 1 year, and 5 years post surgery.
Measured: 6 months, 1 year, 5 years
Mortality
30-day mortality is a secondary end-point.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2014 (estimated)
- Study startJul 2008
- Primary completionJul 2016 (estimated)
- Study completionJul 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fascial ClosureStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 388 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marc A. de Moya, Massachusetts General Hospital
- Investigators
- Marc A de Moya, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02145052
- Sponsor's protocol ID
- 2008-P-000393; MGH
- Status last verified
- Mar 2016
- First submitted
- 20 May 2014
- Last updated
- 29 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Will share de-identified data as needed
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Method of Fascial Closure in High Risk Patients Undergoing Laparotomy: A Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT02145052
- Acronym / sponsor ID
- 2008-P-000393; MGH
- Conditions
- Fascial Closure
- Keywords
- Fascial closure, Interrupted suture, Running suture, Continuous suture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 388 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- Jul 2016 (estimated)
- Study completion
- Jul 2016 (estimated)
- First posted
- 22 May 2014 (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 primary objective of this study is to identify the optimal method of fascial closure of a laparotomy incision in high risk patients for intra-abdominal complications. The investigators hypothesize that interrupted closure is associated with decreased complication rates when compared with running/continuous closure. Secondary objectives are to determine the rate of dehiscence in continuous and interrupted suture technique, and to determine the rate of wound infection, hernia formation, and mortality associated with suture technique.
Detailed description
Secure wound closure is an essential requirement for an uncomplicated and expedient recovery after an abdominal operation. The incidence of dehiscence ranges from 0-6% in different patient series and the associated mortality rate ranges from 10-35% [1]. Median laparotomy is the most common technique of abdominal incisions because it is simple, provides adequate exposure, is rapid to open and usually blood sparing [2]. The two common methods of fascial closure are continuous and interrupted with absorbable or non-absorbable suture. There is little debate that there is no significant difference between the two types of suture material. However, there is an ongoing debate concerning the optimal technique for closure. Both closure techniques are considered standard of care at this time.
The best method of wound closure would be one that provides adequate tensile strength to the incision until the wound is healed, approximates the tissue in a way that normal healing mechanisms can occur under optimal circumstances, remains secure even in the presence of local or systemic infection, the suture material is well tolerated on a short and long term basis, and, finally, should be done with expediency.
Previous randomized controlled trials of abdominal fascial closure have failed to determine the best technique and ideal suture [3]. Fagniez et al. randomized 3135 patients to receive continuous or interrupted sutures and further stratified them according to the type of wound: clean, clean-contaminated, and contaminated. This study looked at all patients, elective and emergent, and there was no statistically significant difference in wound dehiscence between continuous and interrupted suture technique [4]. A similar conclusion for wound dehiscence was shown by Gislason et al. where they compared 599 adults with major GI operation who received continuous or interrupted sutures [5]. In another prospective randomized trial, 571 patients were compared for continuous vs. interrupted sutures; again the dehiscence rate was not significant between the two groups [1]. The common denominator in all of these trials was the inclusion of all patients, elective as well as emergent, undergoing a laparotomy. None of the trials have compared the suture technique for patients requiring emergency laparotomy with wound dehiscence as a primary outcome. Results of these studies were often conflicting and have left many surgeons uncertain about the ideal technique for abdominal fascial closure, leave alone patients undergoing emergency surgery.
There have been no prospective randomized trials that look at the optimal method of fascial closure in high risk patients undergoing laparotomy. Through this research study, the investigators aim to determine identify the optimal method of fascial closure (interrupted vs. running/continuous suture) of a laparotomy incision in high risk patients for intra-abdominal complications
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continuous suture | Active comparator | Other: Continuous suture0 non-looped PDS using a tapered needle starting at the superior and the inferior portions of the wound. Fascia is then approximated with at least 1cm distance from the edge of the fascia and 1cm advancement. The two sutures are then knotted in the center with 8 square knots. |
| Interrupted Suture | Active comparator | Other: Interrupted sutureUsing a tapered needle, 0 non-looped PDS interrupted figure of eight suture 1cm from the edge and advancing 1cm between each suture. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Adult patients >18 years of age, undergoing urgent laparotomy, admitted to the Division of Trauma, Emergency Surgery, and Surgical Critical Care.
Key exclusion criteria (7 listed)
- Pregnant patients
- All elective patients
- Patients with pre-morbid condition not expected to survive >48 hours
- Patients unable to communicate in English
- Patients with primary ventral hernia or recent (within 1 month) abdominal operation.
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 |
|---|---|---|
| Continuous sutureA continuous suture is considered standard of care. | Other | Continuous suture |
| Interrupted sutureInterrupted sutures are considered standard of care. | Other | Interrupted Suture |
Primary outcome
Dehiscence
Time frame: 1 year
Dehiscence will be defined as more than 1cm horizontal defect in the fascia along the suture lines.
3 secondary outcomes
Wound infection
Time frame: 30 days
Incisional Hernia
Time frame: 6 months, 1 year, 5 years
Mortality
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2016.
- Individual participant dataSharing planned: Yes. Will share de-identified data as needed
Related trials for Fascial Closure
RecruitingPhase 4
Preoperative BOTOX® Injection for Large Ventral Hernia Repair
Hernia Abdominal Wall, Botox Injection
Recruiting
Standard Closure vs. Integrated Mesh-Fascial Closure (IMFC) for Incisional Hernia Repair
Incisional Hernia Repair, Ventral Incisional Hernia
Not yet recruiting
Synthetic Mesh for Prevention of HernIa After opEn Abdomen cLosure stuDy
Open Abdomen, Incisional Hernia
RecruitingPhase 2
Study of AGN-151607-DP to Assess Adverse Events and Change in Disease Activity in Adult Participants Undergoing Open Abdominal Ventral Hernia Repair
Ventral Hernia
Not yet recruiting
Fascial Abdominal Closure Evaluation
Hernia Incisional, Suture Materials
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.
Marc A de Moya, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous suture and Interrupted suture in people with Fascial Closure, run by Massachusetts General Hospital 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 1 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: status not confirmed, as of the sponsor's last update on 29 Mar 2016. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
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?
Dehiscence (time frame: 1 year). 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 29 Mar 2016.