Clinical trial NCT02145052: Optimal Method of Fascial Closure in High Risk Patients Undergoing Laparotomy
Official title: Optimal Method of Fascial Closure in High Risk Patients Undergoing Laparotomy: A Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fascial Closure
Keywords: Fascial closure
Interrupted suture
Running suture
Continuous suture
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2014-05-22
Enrollment: 388
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Dehiscence
timeFrame: 1 year
Secondary outcomes:
measure: Wound infection
timeFrame: 30 days
measure: Incisional Hernia
timeFrame: 6 months, 1 year, 5 years
measure: Mortality
timeFrame: 30 days
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Marc A de Moya, MD
role: PRINCIPAL_INVESTIGATOR
References: