Skip to content

Optimal Method of Fascial Closure in High Risk Patients Undergoing Laparotomy

Optimal Method of Fascial Closure in High Risk Patients Undergoing Laparotomy: A Prospective Randomized Study

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02145052
Enrollment
388
Registered
2014-05-22
Start date
2008-07-31
Completion date
2016-07-31
Last updated
2016-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fascial Closure

Keywords

Fascial closure, Interrupted suture, Running suture, Continuous suture

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

Interventions

A continuous suture is considered standard of care.

Interrupted sutures are considered standard of care.

Sponsors

Massachusetts General Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Dehiscence1 yearDehiscence will be defined as more than 1cm horizontal defect in the fascia along the suture lines.

Secondary

MeasureTime frameDescription
Wound infection30 daysSurgical site infections must fulfill the following criteria: 1. Must occur within 30 days of surgery. 2. Must involve only the skin and subcutaneous tissue. 3. Must involve at least one of the following: a) Purulent discharge from a superficial infection; b) Organisms isolated from aseptically obtained wound culture 4. Must involve at least one of the following signs of infection: a) Pain or tenderness; b) Localized swelling; c) Redness or heat
Incisional Hernia6 months, 1 year, 5 yearsIncisional hernia will be identified by following up patients at 6 months, 1 year, and 5 years post surgery.
Mortality30 days30-day mortality is a secondary end-point.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026