A Randomized, Controlled Trial Comparing Wound Complications in Elective Midline Laparotomies Using Two Different Running Suture Techniques

What this Trial Is About

Researchers are evaluating two different techniques for closing abdominal wounds in patients undergoing elective midline laparotomy surgery. The study aims to compare the traditional wide and large stitch method with a newer technique using small, close stitches. This new method is expected to reduce wound complications such as infections, hernias, and wound ruptures, and improve patient quality of life. The trial addresses limitations from prior studies by providing higher quality evidence through a randomized controlled design. Participants will be randomly assigned to either the standard closure technique or the new closure technique. The standard method places about one suture per centimeter of the wound, while the new technique uses smaller stitches placed 5 mm apart and 5 mm from the fascia edge, aiming for a suture-to-wound length ratio of 4:1. The study includes a pilot phase to assess feasibility and adherence. Closure of the skin and subcutaneous tissue, as well as use of drains, will be at the surgeon's discretion following usual care. During the hospital stay, surgeons will visit daily for seven days to assess wound healing and complications. Follow-up calls will remind patients about appointments at 30 days and one year after surgery. The main outcome measured is the incidence of incisional hernia at one year. Other outcomes include wound rupture and interventions for wound complications within 30 days. Data will be collected through physical exams, case report forms, and follow-ups to ensure accuracy. Safety monitoring and data confidentiality are maintained throughout the trial, which is expected to last approximately two years for recruitment plus follow-up.

Comparing Wound Complications After Elective Abdominal Surgery Using Two Closure Techniques