Suture TechniquesPhase 2/3NCT07154277
Small Bites Vs Large Bites Abdominal Midline Incisional Closure
A Phase 2/3 study testing Small bite closure and Large bite closure in people with Suture Techniques and Wound Closure Techniques, run by Dow University of Health Sciences at 1 site in Pakistan.
Trial summary
The goal of this trial is to compare the effectiveness of small bite versus large bite abdominal incision closure in emergency settings. It will also evaluate the safety and outcomes of each technique. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Suture Techniques, Wound Closure Techniques, Laparotomy/Standerds
- What is being tested?
- Small bite closure and Large bite closure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 sitePakistan
- Study dates
- 23 Nov 2023to 24 Dec 2025
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adults ages in between 18-60 year old
- All emergency laparotomies (Except trauma)
Who cannot join
- Previous surgery with midline incision
- Pregnancy
- Current immunosuppressive or chemotherapy
- Previous incisional hernia after midline incision
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Dr. Ruth K. M. Pfau Civil Hospital Karachi
Karachi, Sindh, 74400
About this study
Official title: Abdominal Midline Incisional Closure With Small Bites Vs Large Bites in Emergency Settings
The goal of this trial is to compare the effectiveness of small bite versus large bite abdominal incision closure in emergency settings. It will also evaluate the safety and outcomes of each technique. The main questions it aims to answer are:
Does small bite closure reduce the incidence of superficial surgical site infections (SSI), wound dehiscence, and incisional hernia compared to large bite closure? What are the associated complications of each closure technique?
Read more
Participants will:
Undergo either a small bite or large bite abdominal incision closure during emergency laparotomy Visit the clinic for follow-up assessments at 7 days, 15 days, 1 month, 3 months, and 6 months post-operatively Have their wound healing and complications documented and analyzed during respective visits.
Read the detailed description
Background Wound site complications continue to be a major detrimental factor in surgical healthcare around the globe and are a major concern for general surgeons due to the associated morbidity and mortality. Superficial Surgical Site Infection (SSI) is defined as an infection related to a surgical procedure that occurs near the surgical site within 30 days following surgery (or up to 90 days following surgery where an implant is involved). The incidence of such complications is generally higher in emergency laparotomies compared to elective cases. Surgical technique plays a key role in the integrity of the post-operative wound, and among the numerous factors that influence wound healing, it is the only one under the direct control of the surgeon. The midline incision is the most commonly used surgical incision for emergency laparotomy as it provides quick, wide exposure and avoids damage to nerves, muscles, and the blood supply of the abdominal wall. Closure of the midline wound has traditionally been performed using a mass fashion or large bite technique with a running suture, but recently a new technique of small bite closure has been proposed.
Hypothesis The hypothesis is that small bite closure will have better outcomes than large bite closure in terms of reducing acute wound failure.
Objective This study aims to compare the effectiveness of small bite abdominal incision closure with large bite closure in patients undergoing emergency laparotomy at a tertiary hospital in Karachi, Pakistan.
Materials and Methods
A single-blinded randomized comparative trial will be conducted at Civil Hospital, a tertiary hospital in Karachi, Pakistan. A total of 200 participants will be recruited for this study, with equal participants divided into two groups. Patients undergoing emergency laparotomies will be randomly assigned to one of two groups:
Group A: Participants will undergo large bite closure. Group B: Participants will undergo small bite closure. Participants will be followed up at 7 days, 15 days, 1 month, 3 months, and 6 months postoperatively to assess for complications. Data collection will be done using a single-blinded, block randomization method, where each participant will be assigned a unique code.
Operational Definitions Effectiveness: Defined by the incidence of superficial SSI, wound dehiscence, and incisional hernia in the two study groups.
Superficial SSI: An infection near the surgical site within 30 days of surgery (or up to 90 days with an implant) involving only skin or subcutaneous tissue. Diagnosed by purulent drainage, isolated organisms from an aseptically obtained culture, or symptoms like pain, tenderness, localized swelling, redness, heat, and diagnosis by a surgeon or attending physician.
Wound Dehiscence: Partial or total separation of previously approximated wound edges due to failed wound healing.
Incisional Hernia: An abnormal protrusion of abdominal contents through the weakness in the abdominal wall at the incision site.
Large Bite Closure: Tissue bite of 1cm depth, 1cm travel, and 1cm apart, using Prolene 0.
Small Bite Closure: Tissue bite of 0.5cm depth, 0.5cm travel, and 0.5cm apart, using Prolene 2/0.
Jenkin's Rule: A 4:1 suture to wound ratio. Data Collection and Analysis Data will be collected through a structured Performa and analyzed using the latest version of SPSS. The analysis will focus on comparing the incidence of superficial SSI, wound dehiscence, and incisional hernia between the two groups, providing insights into the effectiveness of each closure technique.
- Conditions
- Suture Techniques, Wound Closure Techniques, Laparotomy/Standerds, Surgical Wound Dehiscence, Incisional Hernia/Prevention and Control, Surgical Wound Infection
- Being tested
- Small bite closure, Large bite closure
- Keywords
- midline abdominal closure, emergency laparotomy, small bite closure, large bite closure, wound closure
- Medical subject headings
- Surgical Wound Dehiscence, Incisional Hernia, Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Small bite closureProcedure or surgery
Also called small bite suturing technique, small bite suture, 0.5*0.5*0.5 suturing technique
Small bite suturing is small tissue bite of 0.5cm depth x 0.5cm travel x 0.5cm apart, on the aponeurosis away from midline using Prolene 2/0
Large bite closureProcedure or surgery
Also called Large bite suturing technique, Large bite suture, Large suturing technique
Large bite closure is defined as tissue bite of 1cm depth x 1 cm travel x 1cm apart, on the aponeurosis away from midline using Prolene 0
| Study group | Role | What they receive |
|---|---|---|
| Large Bite Closure of midline laparotomy wound | Active comparator | Standard closure: Suture bite should be 1 cm away from wound margin and 1 cm apart from the previous suture bite Receives: Procedure: Large bite closure |
| Small Bite Closure of midline laparotomy wound | Experimental | Small Bite closure: Suture bite should be 0.5 cm away from wound margin and 0.5 cm apart from the previous suture bite Receives: Procedure: Small bite closure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Wound Dehiscence
Wound dehiscence as seen by the surgeon.
Measured: 1 month
Number of participants with Surgical Site Infections
As per CDC guidelines and seen by the surgeon
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2025
- Study start23 Nov 2023
- Primary completion24 Dec 2025 (estimated)
- Study completion24 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suture TechniquesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients are randomly categorized into two different groups and treated differently and outcomes are assessed in the same manner in both groups.
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dow University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Omer Bin Khalid Jamil, Principal investigator, Ruth K.M. Pfau Civil Hospital Karachi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07154277
- Sponsor's protocol ID
- 2888
- Status last verified
- Dec 2024
- First submitted
- 12 Jul 2024
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Abdominal Midline Incisional Closure With Small Bites Vs Large Bites in Emergency Settings
- ClinicalTrials.gov ID
- NCT07154277
- Acronym / sponsor ID
- 2888
- Conditions
- Suture Techniques, Wound Closure Techniques, Laparotomy/Standerds, Surgical Wound Dehiscence, Incisional Hernia/Prevention and Control, Surgical Wound Infection
- Keywords
- midline abdominal closure, emergency laparotomy, small bite closure, large bite closure, wound closure
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Dow University of Health SciencesUniversity, hospital or other
- Study start
- 23 Nov 2023 (actual)
- Primary completion
- 24 Dec 2025 (estimated)
- Study completion
- 24 Dec 2025 (estimated)
- First posted
- 4 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this trial is to compare the effectiveness of small bite versus large bite abdominal incision closure in emergency settings. It will also evaluate the safety and outcomes of each technique. The main questions it aims to answer are:
Does small bite closure reduce the incidence of superficial surgical site infections (SSI), wound dehiscence, and incisional hernia compared to large bite closure? What are the associated complications of each closure technique?
Participants will:
Undergo either a small bite or large bite abdominal incision closure during emergency laparotomy Visit the clinic for follow-up assessments at 7 days, 15 days, 1 month, 3 months, and 6 months post-operatively Have their wound healing and complications documented and analyzed during respective visits.
Detailed description
Background Wound site complications continue to be a major detrimental factor in surgical healthcare around the globe and are a major concern for general surgeons due to the associated morbidity and mortality. Superficial Surgical Site Infection (SSI) is defined as an infection related to a surgical procedure that occurs near the surgical site within 30 days following surgery (or up to 90 days following surgery where an implant is involved). The incidence of such complications is generally higher in emergency laparotomies compared to elective cases. Surgical technique plays a key role in the integrity of the post-operative wound, and among the numerous factors that influence wound healing, it is the only one under the direct control of the surgeon. The midline incision is the most commonly used surgical incision for emergency laparotomy as it provides quick, wide exposure and avoids damage to nerves, muscles, and the blood supply of the abdominal wall. Closure of the midline wound has traditionally been performed using a mass fashion or large bite technique with a running suture, but recently a new technique of small bite closure has been proposed.
Hypothesis The hypothesis is that small bite closure will have better outcomes than large bite closure in terms of reducing acute wound failure.
Objective This study aims to compare the effectiveness of small bite abdominal incision closure with large bite closure in patients undergoing emergency laparotomy at a tertiary hospital in Karachi, Pakistan.
Materials and Methods
A single-blinded randomized comparative trial will be conducted at Civil Hospital, a tertiary hospital in Karachi, Pakistan. A total of 200 participants will be recruited for this study, with equal participants divided into two groups. Patients undergoing emergency laparotomies will be randomly assigned to one of two groups:
Group A: Participants will undergo large bite closure. Group B: Participants will undergo small bite closure. Participants will be followed up at 7 days, 15 days, 1 month, 3 months, and 6 months postoperatively to assess for complications. Data collection will be done using a single-blinded, block randomization method, where each participant will be assigned a unique code.
Operational Definitions Effectiveness: Defined by the incidence of superficial SSI, wound dehiscence, and incisional hernia in the two study groups.
Superficial SSI: An infection near the surgical site within 30 days of surgery (or up to 90 days with an implant) involving only skin or subcutaneous tissue. Diagnosed by purulent drainage, isolated organisms from an aseptically obtained culture, or symptoms like pain, tenderness, localized swelling, redness, heat, and diagnosis by a surgeon or attending physician.
Wound Dehiscence: Partial or total separation of previously approximated wound edges due to failed wound healing.
Incisional Hernia: An abnormal protrusion of abdominal contents through the weakness in the abdominal wall at the incision site.
Large Bite Closure: Tissue bite of 1cm depth, 1cm travel, and 1cm apart, using Prolene 0.
Small Bite Closure: Tissue bite of 0.5cm depth, 0.5cm travel, and 0.5cm apart, using Prolene 2/0.
Jenkin's Rule: A 4:1 suture to wound ratio. Data Collection and Analysis Data will be collected through a structured Performa and analyzed using the latest version of SPSS. The analysis will focus on comparing the incidence of superficial SSI, wound dehiscence, and incisional hernia between the two groups, providing insights into the effectiveness of each closure technique.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients are randomly categorized into two different groups and treated differently and outcomes are assessed in the same manner in both groups.
| Arm | Type | Receives |
|---|---|---|
| Large Bite Closure of midline laparotomy wound | Active comparator | Procedure: Large bite closureStandard closure: Suture bite should be 1 cm away from wound margin and 1 cm apart from the previous suture bite |
| Small Bite Closure of midline laparotomy wound | Experimental | Procedure: Small bite closureSmall Bite closure: Suture bite should be 0.5 cm away from wound margin and 0.5 cm apart from the previous suture bite |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Adults ages in between 18-60 year old
- All emergency laparotomies (Except trauma)
Key exclusion criteria (4 listed)
- Previous surgery with midline incision
- Pregnancy
- Current immunosuppressive or chemotherapy
- Previous incisional hernia after midline incision
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Small bite closureAlso: small bite suturing technique, small bite suture, 0.5*0.5*0.5 suturing techniqueSmall bite suturing is small tissue bite of 0.5cm depth x 0.5cm travel x 0.5cm apart, on the aponeurosis away from midline using Prolene 2/0 | Procedure or surgery | Small Bite Closure of midline laparotomy wound |
| Large bite closureAlso: Large bite suturing technique, Large bite suture, Large suturing techniqueLarge bite closure is defined as tissue bite of 1cm depth x 1 cm travel x 1cm apart, on the aponeurosis away from midline using Prolene 0 | Procedure or surgery | Large Bite Closure of midline laparotomy wound |
Primary outcome
Number of participants with Wound Dehiscence
Time frame: 1 month
Wound dehiscence as seen by the surgeon.
Number of participants with Surgical Site Infections
Time frame: 1 month
As per CDC guidelines and seen by the surgeon
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Omer Bin Khalid Jamil principal investigator
Ruth K.M. Pfau Civil Hospital Karachi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Small bite closure and Large bite closure in people with Suture Techniques and Wound Closure Techniques, run by Dow University of Health Sciences at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 4 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with Wound Dehiscence (time frame: 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2025.