Abdominal Midline Wound Closure: Small Tissue Bites Versus Large Tissue Bites

Indus Hospital and Health Network

Status: Completed

Conditions: Stitch Technique

Treatments: Procedure: Small Stitch Closure Technique; Procedure: Large Stitch Closure Technique

Study type: Interventional

Funder types: Other

Identifiers

NCT07621926

IHHN_IRB_2024_03_014

Details and patient eligibility

About

The goal of this clinical trial is to learn whether a small stitch technique works better than a large bite technique for closing midline abdominal surgery wounds in adults having midline laparotomy surgery.

The main questions it aims to answer are:

Does the small stitch technique lower the risk of surgical site infection? Does the small stitch technique lower the risk of wound dehiscence (reopening of the wound)? Researchers will compare the small stitch technique with the large bite technique to see if the small stitch technique leads to fewer wound complications after surgery.

Participants will:

Have their abdominal wound closed using either the small stitch or large bite technique during surgery Attend follow-up visits at 2 weeks and 1 month after surgery Be checked for wound complications, including infection and wound reopening In the small stitch technique, stitches are placed 5 millimeters from the wound edge and 5 millimeters apart. In the large bite technique, stitches are placed 10 millimeters apart.

Full description

This clinical trial is designed to evaluate two different methods of closing abdominal wounds after midline laparotomy surgery in adults. A midline laparotomy is a common surgical procedure in which an incision is made along the middle of the abdomen to allow surgeons access to internal organs. Proper closure of this incision is important because complications such as infection or reopening of the wound can lead to pain, delayed recovery, longer hospital stays, and additional treatment.

The study focuses on comparing a "small stitch" technique with the more traditional "large bite" technique used to close the abdominal wall at the end of surgery. Researchers want to determine whether the small stitch method can improve healing and reduce complications after surgery.

In the small stitch technique, sutures are placed approximately 5 millimeters from the edge of the wound and spaced 5 millimeters apart. This approach is designed to distribute tension more evenly across the wound and may help preserve blood supply to the tissues, potentially improving healing. In the large bite technique, stitches are placed farther from the wound edge and farther apart, which is the conventional method commonly used in many surgical settings.

The main goals of the study are to determine:

Whether the small stitch technique reduces the risk of surgical site infections Whether the small stitch technique lowers the chance of wound dehiscence, a serious complication in which the surgical wound partially or completely reopens after surgery Adults undergoing midline laparotomy surgery may be eligible to participate. During the procedure, participants will have their abdominal incision closed using either the small stitch or the large bite technique. The method used will be assigned according to the study protocol so that researchers can fairly compare outcomes between the two groups.

After surgery, participants will continue with routine postoperative care and attend follow-up visits approximately 2 weeks and 1 month after their operation. At these visits, the surgical wound will be examined for signs of infection, delayed healing, wound reopening, pain, or other complications. Researchers will collect and compare the results from both groups to determine which closure method provides better outcomes.

The information gained from this study may help surgeons identify the safest and most effective way to close abdominal incisions, potentially improving recovery and reducing postoperative complications for future patients undergoing abdominal surgery.

Enrollment: 88 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

. Age 18-80 years, either sex

• Midline laparotomy (elective or emergency)
• ASA class I-IV

Exclusion criteria

• Previous incisional hernia or midline incision
• Contaminated surgery
• ASA V-VI

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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88 participants in 2 patient groups

Small Stitch Closure Technique

Active Comparator group

Description:

Participants in this arm will undergo abdominal wall closure using the small stitch technique following midline laparotomy surgery.

Treatment:

Procedure: Small Stitch Closure Technique

Large Stitch Closure Technique

Active Comparator group

Description:

Participants in this arm will undergo abdominal wall closure using the large stitch technique following midline laparotomy surgery

Treatment:

Procedure: Large Stitch Closure Technique