NCT03527433 Comparing Wound Complications After Elective Abdominal Surgery Using Two Closure Techniques
| NCT ID | NCT03527433 |
| Status | Recruiting |
| Phase | — |
| Sponsor | American University of Beirut Medical Center |
| Condition | Wound Complication |
| Study Type | INTERVENTIONAL |
| Enrollment | 274 participants |
| Start Date | 2019-10-01 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 274 participants in total. It began in 2019-10-01 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Wound complications, increased hospital stays and post-operative morbidity are all common following abdominal surgery. Abdominal closure complications are strongly associated with the closure technique and material used. The traditional closure technique used by surgeons is placing the wide and large stitches. A randomized controlled trial done in Sweden described a new closure technique in surgeries by placing the stitches closer to each other by using narrow. The results showed lower incidence of wound infections, hernias, and wound rupture. However, the study provides low quality evidence on the benefits of this new technique since it has numerous limitations like lack of standardization of suture size, lack of proper randomization, and heterogeneity in patient eligibility which will increase result bias. There is still a need for quality evidence on the effectiveness of this new closing technique procedure at decreasing wound complications after the operation. In this trial the investigators will compare two techniques in the closure of abdominal wounds in patients undergoing abdominal surgery. The first technique will be the traditional closure technique currently used in abdominal surgery. The second technique will be using the new closure technique. The closure of abdominal wounds with small and close sutures using the new technique is expected to lower the incidence of hernia and wound complications as well as improve the quality of life of the patient. Potential candidates for the study are those who will be undergoing elective midline laparotomy at AUBMC. The patients and assessor of outcomes will be blinded and patients will be randomized to receive either the traditional or new closure operation technique. There are no anticipated risks for those participating in the study. All data and information collected will be kept confidential. Hypothesis: Closure of abdominal fascia in elective midline laparotomy incisions with small and close sutures compared to closure with conventional wide and distant sutures results in lower rates of wound rupture, incisional hernia, and wound infection, and improved quality of life. Significance: The results of this study will allow surgeons to assess the role of a new abdominal closure technique in decreasing short and long term postoperative complications, for a commonly performed procedure. This trial will generate evidence-based conclusions.
Eligibility Criteria
Inclusion Criteria: * Age 18 years or older * Signed Informed Consent * Undergoing an elective laparotomy through a midline incision * Undergoing a midline laparoscopic procedure (midline laparoscopic extraction site) Exclusion Criteria: * Emergency surgery * Laparotomy through an incision other than midline * Previous midline laparotomy * Presence of incisional or ventral hernia at time of laparotomy * Incisional hernia repair * Laparotomy surgery during pregnancy
Contact & Investigator
Eman Sbaity, MD
PRINCIPAL INVESTIGATOR
American University of Beirut Medical Center
Frequently Asked Questions
Who can join the NCT03527433 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Wound Complication. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03527433 currently recruiting?
Yes, NCT03527433 is actively recruiting participants. Contact the research team at es25@aub.edu.lb for enrollment information.
Where is the NCT03527433 trial being conducted?
This trial is being conducted at Beirut, Lebanon.
Who is sponsoring the NCT03527433 clinical trial?
NCT03527433 is sponsored by American University of Beirut Medical Center. The principal investigator is Eman Sbaity, MD at American University of Beirut Medical Center. The trial plans to enroll 274 participants.