Complications Wounds, Laparotomy Closure After Abdominal Surgery, Suture Materials
Conditions
Keywords
Prolene, Vicryl, Laparotomy, Wound Dehiscence, Surgical site infection
Brief summary
This randomized controlled trial compared two commonly used suture materials, Prolene and Vicryl, for closing the midline rectus sheath after elective laparotomy. Proper closure of the abdominal wall is important to reduce complications such as wound dehiscence and surgical site infection. Adult patients undergoing elective midline laparotomy were randomly assigned to rectus sheath closure using either Prolene or Vicryl sutures. All patients received the same standardized surgical technique and postoperative care. Participants were followed for 30 days after surgery to assess wound healing, wound dehiscence, surgical site infection, and length of hospital stay. The study aimed to determine which suture material is associated with fewer postoperative wound complications.
Detailed description
This prospective randomized controlled trial was conducted in the Department of General Surgery at Hayatabad Medical Complex, Peshawar. The study enrolled adult patients aged 18 to 70 years who underwent elective midline laparotomy for various abdominal conditions. Patients with malnutrition or anemia (hemoglobin \< 10 g/dL), immunocompromised states, active infection, pregnancy, prior chemotherapy or radiotherapy, or previous midline laparotomy were excluded. A total of 152 patients were randomly allocated into two equal groups. Group A underwent midline rectus sheath closure using Prolene 1 (polypropylene, non-absorbable monofilament) suture, while Group B underwent closure using Vicryl 1 (polyglactin 910, absorbable braided) suture. Randomization was performed using a simple randomization method. In both groups, a standardized continuous mass closure technique was used, maintaining a suture-to-wound length ratio of 4:1 with small bites taken at regular intervals. Skin closure was performed using interrupted non-absorbable sutures. All surgeries were performed under the supervision of senior specialist surgeons, and standard perioperative care, including antibiotic prophylaxis and postoperative wound care, was provided. Patients were followed for 30 days after surgery through inpatient observation and outpatient follow-up visits. Wounds were assessed clinically for evidence of wound dehiscence and surgical site infection. The primary outcome measure was the incidence of wound dehiscence within 30 days postoperatively. Secondary outcome measures included surgical site infection and length of hospital stay. Data were collected using a structured proforma and analyzed using statistical software. The study was approved by the institutional ethical review board and conducted in accordance with ethical principles for human research.
Interventions
Vicryl (polyglactin 910) is an absorbable braided synthetic suture used for closure of the rectus sheath during elective midline laparotomy. The suture is applied using a standard mass closure technique according to institutional surgical protocols.
Prolene (polypropylene) is a non-absorbable monofilament synthetic suture used for closure of the rectus sheath during elective midline laparotomy. The suture is applied using a standard mass closure technique according to institutional surgical protocols.
Sponsors
Study design
Masking description
This is an open-label study as the operating surgeon is aware of the suture material used.
Intervention model description
Participants undergoing elective midline laparotomy are assigned to one of two parallel groups based on the type of suture material used for rectus sheath closure.
Eligibility
Inclusion criteria
* Age 18 to 70 years * Patients undergoing elective midline laparotomy * Ability to provide written informed consent
Exclusion criteria
* Emergency laparotomy * Previous abdominal mesh placement * Immunocompromised patients * Pregnant women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Surgical Site Infection within 30 Days Post-Laparotomy | 30 days | Surgical site infection (SSI) is defined as purulent discharge, erythema, or positive microbiology from the incision site within 30 days postoperatively. All infections will be classified and documented according to CDC guidelines. |
| Incidence of Wound Dehiscence within 30 Days Post-Laparotomy | 30 days postoperatively | Wound dehiscence is defined as the separation of the rectus sheath or wound edges, including partial or complete dehiscence, observed within 30 days after midline laparotomy. Clinical examination will be used to assess wound integrity, and findings will be documented in the patient's medical record. |
Countries
Pakistan
Contacts
Hayatabad Medical Complex