Optimal Method of Fascial Closure in High Risk Patients Undergoing Laparotomy

NCT02145052 | Unknown

• 1 other identifier: 2008-P-000393; MGH
• Study Type: interventional
• Target: 388
• Locations: 1 country
• Sites: 1

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.

Conditions

Fascial Closure

Keywords

Fascial closure; Interrupted suture; Running suture; Continuous suture

Outcome Measures

Primary Outcomes (1)

• Dehiscence

  Dehiscence will be defined as more than 1cm horizontal defect in the fascia along the suture lines.

  1 year

Secondary Outcomes (3)

• Wound infection

  30 days

• Incisional Hernia

  6 months, 1 year, 5 years

• Mortality

  30 days

Study Arms (2)

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.

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.

Other: Interrupted suture

Interventions

Continuous suture OTHER

A continuous suture is considered standard of care.

Continuous suture

Interrupted suture OTHER

Interrupted sutures are considered standard of care.

Interrupted Suture

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Study Officials

• Marc A de Moya, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Surgery

Study Record Dates

• First Submitted: May 20, 2014
• First Posted: May 22, 2014
• Study Start: July 1, 2008
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: March 29, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will share

Locations

US (1)