Optimal Method of Fascial Closure in High Risk Patients Undergoing Laparotomy

NCT ID: NCT02145052

Last Updated: 2016-03-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 388 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-07-31
• Study Completion Date: 2016-07-31

Brief 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 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

Conditions

Fascial Closure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Continuous suture

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.

Group Type: ACTIVE_COMPARATOR

Continuous suture

Intervention Type: OTHER

A continuous suture is considered standard of care.

Interrupted Suture

Using a tapered needle, 0 non-looped PDS interrupted figure of eight suture 1cm from the edge and advancing 1cm between each suture.

Group Type: ACTIVE_COMPARATOR

Interrupted suture

Intervention Type: OTHER

Interrupted sutures are considered standard of care.

Interventions

Continuous suture

A continuous suture is considered standard of care.

Intervention Type: OTHER

Interrupted suture

Interrupted sutures are considered standard of care.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Adult patients >18 years of age, undergoing urgent laparotomy, admitted to the Division of Trauma, Emergency Surgery, and Surgical Critical Care.

Exclusion Criteria

1. Pregnant patients

2. All elective patients

3. Patients with pre-morbid condition not expected to survive >48 hours

4. Patients unable to communicate in English

5. Patients with primary ventral hernia or recent (within 1 month) abdominal operation.

6. Patients with mesh in place

7. Trauma patients

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Marc A. de Moya

Assistant Professor of Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marc A de Moya, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

2008-P-000393; MGH

Identifier Type: -

Identifier Source: org_study_id