- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07241507
Effect of Continuous Versus Interrupted Suturing on Wound Dehiscence and Infection After Abdominal Surgery
Frequency of Wound Dehiscence and Wound Infection in Continuous Versus Interrupted Suturing for Abdominal Closure in Exploratory Laparotomy
The goal of this clinical trial is to learn whether the type of suturing technique used to close the abdomen after exploratory laparotomy affects the rate of wound complications. Specifically, the study aims to find out if using interrupted sutures results in fewer cases of wound dehiscence (wound reopening) compared to continuous sutures.
The main question the study seeks to answer is:
Does interrupted suturing reduce the frequency of wound dehiscence compared to continuous suturing in patients undergoing exploratory laparotomy?
Researchers will also observe and compare wound infection rates between the two suturing methods.
About 80 adult patients (18-60 years old) undergoing exploratory laparotomy at the Department of General Surgery, DHQ Teaching Hospital, Dera Ghazi Khan, will take part in this study. Participants will be randomly assigned to one of two groups:
Group A: Continuous abdominal closure using No. 1 Vicryl suture
Group B: Interrupted abdominal closure using No. 1 Vicryl suture
All participants will have their baseline characteristics recorded, including age, gender, obesity, diabetes, and smoking status. The surgical technique and postoperative care will follow the hospital's standard protocols. After surgery, patients will be followed for four weeks with weekly clinical assessments to check for wound infection or wound dehiscence.
The hypothesis is that patients whose abdominal wounds are closed with interrupted sutures will have a lower frequency of wound dehiscence compared to those with continuous sutures.
The findings will help guide surgeons on which abdominal closure method provides better wound healing and fewer postoperative complications.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Punjab Province
-
Dera Ghazi Khan, Punjab Province, Pakistan, 32200
- Allama Iqbal Teaching Hospital, Dera Ghazi Khan
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Undergoing exploratory laparotomy
- Both emergency and elective
Exclusion Criteria:
- Patients undergoing second laparotomy or re- laparotomy
- Patients on steroid therapy (assessed on medical record review)
- Patients who die within 28-days of surgery
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Group A - Continuous
Continuous Suture
|
After an exploratory laparotomy continuous suturing using a single thread of Vicryl No. 1 will be used to stitch the incision's fascial layer together, 1 cm distance from wound edges and between each stitch, creating a line of even tension across the wound.
|
|
Experimental: Group B - Interrupted
Interrupted Suture
|
After an exploratory laparotomy, interrupted suturing using a single thread of Vicryl No. 1 will be used to stitch the incision's fascial layer together, 1 cm distance from wound edges and between each stitch.
A knot will be tied after each suture is passed through the tissue, and each stitch will be secured with its own knot.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Wound Dehiscence
Time Frame: From enrollment to 28-days of operation
|
A partial or total separation of previously approximated wound edges, on clinical examination of surgical wound.
|
From enrollment to 28-days of operation
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Surgical Wound Infection
Time Frame: From enrollment to 28-days after operation
|
Presence any features of erythema, pain, pus discharge on examination of surgical wound and new onset fever (> 98.60F)
|
From enrollment to 28-days after operation
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Malik N Fareed, FCPS, Allama Iqbal teaching hospital Dera Ghazi Khan
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- U1111-1329-8430
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Wound Infection, Surgical
-
St. Borbala HospitalSemmelweis University; Department of Surgery, Jahn Ferend Dél-Pesti Kórház... and other collaboratorsTerminatedSurgical Wound | Surgical Site Infection | Wound Dehiscence, Surgical | Dehiscence of Internal Surgical WoundHungary
-
Centro Hospitalar do Tâmega e SousaActive, not recruitingSurgical Wound | Surgical Wound Infection | Surgical Site Infection | Surgical Wound, Healed | Surgical Complication | Surgical Wound Dehiscence | Surgical Wound HaemorrhagePortugal
-
University of Nevada, Las VegasRecruitingColorectal Disorders | Surgical Site Infection | Wound SurgicalUnited States
-
HITEC-Institute of Medical SciencesCompletedWound Infection | Wound Dehiscence | Wound Surgical | Wound BleedingPakistan
-
Hull University Teaching Hospitals NHS TrustUniversity of HullCompletedSurgical Wound | Wound Infection | Surgical Incision | Infection, Bacterial | Wound Infection, SurgicalUnited Kingdom
-
Associazione Infermieristica per lo studio delle...Unknown
-
Imperial College LondonWithdrawnSurgical Wound | Surgical Site Infection | Wound Infection | Surgical Incision
-
Rothman Institute OrthopaedicsUnknownSurgical IncisionUnited States
-
Clinique OrtosCompleted
-
Next Science TMUniversity of Maryland, BaltimoreWithdrawnSurgical Wound | Surgical Wound Infection | Surgical Site Infection | Surgical Incision | Amputation Stump; Infection
Clinical Trials on Continuous suturing
-
RESnTEC, Institute of ResearchCompleted
-
Başakşehir Çam & Sakura City HospitalCompletedEpisiotomy Wound | Labor; Prolonged, Second StageTurkey
-
King Edward Medical UniversityRecruitingBowel Perforated | Duodenal PerforationPakistan
-
Cairo UniversityCompleted
-
Islamabad Medical and Dental CollegeCompleted
-
Benha UniversityCompletedCesarean Section Complications | Myometrial Remodeling | Suture Techniques | Scar NicheEgypt
-
Ain Shams UniversityCompletedSurgical Site Infection
-
Children Hospital and Institute of Child Health...CompletedPain, Acute PostoperativePakistan
-
Diala BurjakCompletedStudent Education | Hands-on Training | Online Education | Suture Techniques | Training EffectivenessJordan