Fascial Closure Clinical Trial
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.
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
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
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