Wound Dehiscence, SurgicalFarrukh 24NCT06697067
The Comparison of Interrupted Modified Smead-Jones Versus Conventional Continuous Suturing Technique for Closure of Rectus Sheath in Patients Undergoing Laparotomy for Hollow Viscus Perforation.
A study testing modified smead jones and conventional comtinuous suture techniques in people with Wound Dehiscence, Surgical, run by King Edward Medical University at 1 site in Pakistan.
Trial summary
After taking approval from Board of Studies, IRB \& ASRB of KEMU, 108 patients fulfilling inclusion criteria will be admitted in Department of General Surgery, East Surgical Ward, Mayo Hospital Lahore through Emergency Department. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Wound Dehiscence, Surgical
- What is being tested?
- modified smead jones and conventional comtinuous suture techniques
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 sitePakistan
- Study dates
- 6 Jun 2024to 21 Jun 2025
- Phase
- Interventional
- 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
Inclusion Criteria:All patients of both genders with age greater than 18 to 60 years, undergoing emergency laparotomy through midline incision for hollow viscus perforation.
ASA grade III -
Exclusion Criteria:Patients who had undergone a previous laparotomy for any condition or had an incisional hernia or burst abdomen at presentation.
Patients undergoing laparotomy with anterior abdominal wall injury in the form of muscle, hematoma, disruption or abdominal wall laceration.
-
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Department of Surgery, King Edward Medical University
Lahore, Punjab Province, 54000
Dr Farrukh Riaz, +92 305 7455349, drroyfarrukhr@gmail.com
About this study
After taking approval from Board of Studies, IRB \& ASRB of KEMU, 108 patients fulfilling inclusion criteria will be admitted in Department of General Surgery, East Surgical Ward, Mayo Hospital Lahore through Emergency Department. Firstly patients will be seen in emergency department, history and clinical examination will be done and laboratory investigations and imaging will be done. All the patients aged greater than 18 years undergoing emergency laparotomy for hollow viscus perforation will be included in the study. Informed consent will be obtained. Demographic data including name, age, sex will be recorded.
Emergency laparotomy will be done with midline incision and intra-operative findings will be recorded. Thorough peritoneal lavage will be done and necessary procedures will be carried out for the pathology identified, and abdominal drains will be placed. The patients then will be randomly divided into 2 groups; group A (Experimental Group) undergoing Modified Smead-Jones interrupted suture technique and group B (Reference Group) undergoing conventional continuous suture closure of rectus sheath. In Modified Smead-jones suture technique describe as a far bite starting at 2 cm on the edge of linea from outside-in and then taking a near bite of 0.5 cm on the other side inside-out- a near bite on the same side outside-in and then a far bite on the other side inside-out. The suture was next converted to a horizontal mattress by taking a far bite 1 cm above or below the previous bite on the other side- near bite on the same side, near bite on the other side, and finally a far bite on the same side. The two ends of the suture were tied to approximate the edges of the linea alba9. In conventional continuous closure suture technique I will use number 1 polypropylene suture, care being taken to place each bite 1-1.5 cm from the cut edge of linea alba and successive bites being taken 1cm away from each other The edges of linea alba were gently approximated without strangulation with an attempt to keep a suture to wound length ratio of 4:110.Rectus sheath will be closed by the suture material No.1 polypropylene in both groups.
The midline laparotomy wound will be managed with daily antiseptic dressing and intravenous antibiotics. All patients will be examined daily till discharge then weekly till 2 weeks and on each visit, a slandered physical examination of abdomen of wound will be done and presence of burst abdomen will be noted. When there are no signs of burst abdomen (after 14 postoperative days) the laparotomy wound will be considered normal. All the data will be collected in accordance to patient's proforma.
Read the detailed description
An emergency laparotomy is a common surgical procedure, performed for a wide variety of intra-abdominal pathologies, which has a significant associated morbidity and mortality. Each year, approximately 30,000 emergency laparotomies are performed in the UK [1]. A major surgical complication after emergency midline laparotomy is abdominal fascial dehiscence. Dehiscence is associated with increased morbidity and mortality rates up to 30%, prolonged hospital stay, and a long-term risk of developing incisional hernia [1].
Hollow viscus perforation is one of the most common cause of peritonitis necessitating emergency surgical intervention. The diagnosis is mainly based on clinical grounds. Plain abdominal X-rays (erect) may reveal dilated and edematous intestines with pneumoperitoneum. Local findings include abdominal tenderness, guarding or rigidity, distension, diminished bowel sounds and systemic findings include fever, chills or rigor, tachycardia, sweating, tachypnea, restlessness, dehydration, oliguria, disorientation and ultimately shock. Exposure of the normally sterile peritoneal cavity to intraluminal contents causes secondary bacterial peritonitis. The peritoneal contamination due to bowel perforation is one of the leading risk factor for occurrence of burst abdomen [2].
Laparotomy wound dehiscence (LWD) is a term used to describe separation of the layers of a laparotomy wound before complete healing has taken place. Other terms used interchangeably are acute laparotomy wound failure and burst abdomen. Frequency of laparotomy wound dehiscence in the relevant literature is cited in the range of 0.2% to 10%[3,4]. The occurrence of fascial dehiscence represents a risk factor for increased mortality rates of up to 25%[5] [11] [12] Acute wound failure may be occult or overt, partial or complete. Overt wound failure follows early removal of sutures leading to evisceration. Occult dehiscence occurs with disruption of musculo-aponeurotic layer beneath intact skin sutures. Wound dehiscence has been noted to occur when a wound fails to gain sufficient strength to withstand stresses placed upon it. The separation may occur when overwhelming forces break sutures, when absorbable sutures dissolve too quickly or when tight sutures cut through tissues [6].
Conventional continuous closure technique has been shown to compromise blood supply and thereby poor wound holding, during initial phases of wound dehiscence. Surgeons have been continuously striving to overcome postoperative complications associated with laparotomy wound closure using newer techniques and newer suture materials. Several reviews have studied the optimal suture repair for closing the abdominal fascia, but no consensus has been reached. Hence, it is imperative for us to ascertain better method of closing the abdomen. While the choice may not be so important in elective patients who are nutritionally adequate, do not have any risk factor for dehiscence and are well prepared for surgery, however it may prove crucial in emergency patients who often have multiple risk factors for developing dehiscence and the strangulation of the sheath is the proverbial last straw in precipitating wound failure Majority of the studies suggest that, the most effective method of midline abdominal fascial closure in the elective setting is mass closure incorporating all layers of abdominal wall except skin in continuous technique with No. 1 or 2 delayed absorbable monofilament suture material with suture length to wound length ratio 4:14-7 .Many randomized controlled trials showed that odds of the burst abdomen are reduced with the interrupted method of closure as compared to continuous.
A study done by AGHARA CB et al8 to compare incidence of burst abdomen between modified smead-jones interrupted suture technique (2%) versus conventional continuous closure (14%) in patient undergoing hollow visus perforation. However the previous done studies have not taken into account a specific population with specific risk factor to compare these two suturing techniques so the aim of present study is to compare the incidence of burst abdomen in the patient undergoing midline abdominal wall closure with modified smead jones interrupted suture9 techniques (Experimental group) and conventional continuous suturing technique10 (Reference Group) in patient undergoing emergency laparotomy for hollow viscus perforation.
- Conditions
- Wound Dehiscence, Surgical
- Being tested
- modified smead jones, conventional comtinuous suture techniques
- Keywords
- Farrukh 24
- Medical subject headings
- Surgical Wound Dehiscence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
modified smead jonesProcedure or surgery
interrupted suture technique
conventional comtinuous suture techniquesProcedure or surgery
continuous suture technique
| Study group | Role | What they receive |
|---|---|---|
| Patient undergoing emergent laparotomy due to hollow viscus perforation | Experimental | Not described Receives: Procedure: modified smead jones |
| patient undergoing emergent laparotomy | Experimental | patient undergoing emergent laparotomy for hollow viscus perforation Receives: Procedure: conventional comtinuous suture techniques |
What is being measured
The primary outcome is the main question the study is designed to answer.
safety
best closure technique of rectus sheath
Measured: 15days after emergent laparotomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2024
- Study start6 Jun 2024
- Primary completion6 Jun 2025 (estimated)
- Study completion21 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound Dehiscence, SurgicalStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised control trials
- Masking
- None (open label)
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Edward Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Mayo Hospital Lahore
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06697067
- Sponsor's protocol ID
- 163/RC/Kemu
- Other IDs
- 12921/REG/KEMU/24
- Acronym
- Farrukh 24
- Status last verified
- Nov 2024
- First submitted
- 17 Nov 2024
- Last updated
- 20 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: still under consideration
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparison of Interrupted Modified Smead-Jones Versus Conventional Continuous Suturing Technique for Closure of Rectus Sheath in Patients Undergoing Laparotomy for Hollow Viscus Perforation.
- ClinicalTrials.gov ID
- NCT06697067
- Acronym / sponsor ID
- Farrukh 24 / 163/RC/Kemu
- Conditions
- Wound Dehiscence, Surgical
- Keywords
- Farrukh 24
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- King Edward Medical UniversityUniversity, hospital or other
- Collaborators
- Mayo Hospital Lahore
- Study start
- 6 Jun 2024 (actual)
- Primary completion
- 6 Jun 2025 (estimated)
- Study completion
- 21 Jun 2025 (estimated)
- First posted
- 20 Nov 2024 (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.
After taking approval from Board of Studies, IRB \& ASRB of KEMU, 108 patients fulfilling inclusion criteria will be admitted in Department of General Surgery, East Surgical Ward, Mayo Hospital Lahore through Emergency Department. Firstly patients will be seen in emergency department, history and clinical examination will be done and laboratory investigations and imaging will be done. All the patients aged greater than 18 years undergoing emergency laparotomy for hollow viscus perforation will be included in the study. Informed consent will be obtained. Demographic data including name, age, sex will be recorded.
Emergency laparotomy will be done with midline incision and intra-operative findings will be recorded. Thorough peritoneal lavage will be done and necessary procedures will be carried out for the pathology identified, and abdominal drains will be placed. The patients then will be randomly divided into 2 groups; group A (Experimental Group) undergoing Modified Smead-Jones interrupted suture technique and group B (Reference Group) undergoing conventional continuous suture closure of rectus sheath. In Modified Smead-jones suture technique describe as a far bite starting at 2 cm on the edge of linea from outside-in and then taking a near bite of 0.5 cm on the other side inside-out- a near bite on the same side outside-in and then a far bite on the other side inside-out. The suture was next converted to a horizontal mattress by taking a far bite 1 cm above or below the previous bite on the other side- near bite on the same side, near bite on the other side, and finally a far bite on the same side. The two ends of the suture were tied to approximate the edges of the linea alba9. In conventional continuous closure suture technique I will use number 1 polypropylene suture, care being taken to place each bite 1-1.5 cm from the cut edge of linea alba and successive bites being taken 1cm away from each other The edges of linea alba were gently approximated without strangulation with an attempt to keep a suture to wound length ratio of 4:110.Rectus sheath will be closed by the suture material No.1 polypropylene in both groups.
The midline laparotomy wound will be managed with daily antiseptic dressing and intravenous antibiotics. All patients will be examined daily till discharge then weekly till 2 weeks and on each visit, a slandered physical examination of abdomen of wound will be done and presence of burst abdomen will be noted. When there are no signs of burst abdomen (after 14 postoperative days) the laparotomy wound will be considered normal. All the data will be collected in accordance to patient's proforma.
Detailed description
An emergency laparotomy is a common surgical procedure, performed for a wide variety of intra-abdominal pathologies, which has a significant associated morbidity and mortality. Each year, approximately 30,000 emergency laparotomies are performed in the UK [1]. A major surgical complication after emergency midline laparotomy is abdominal fascial dehiscence. Dehiscence is associated with increased morbidity and mortality rates up to 30%, prolonged hospital stay, and a long-term risk of developing incisional hernia [1].
Hollow viscus perforation is one of the most common cause of peritonitis necessitating emergency surgical intervention. The diagnosis is mainly based on clinical grounds. Plain abdominal X-rays (erect) may reveal dilated and edematous intestines with pneumoperitoneum. Local findings include abdominal tenderness, guarding or rigidity, distension, diminished bowel sounds and systemic findings include fever, chills or rigor, tachycardia, sweating, tachypnea, restlessness, dehydration, oliguria, disorientation and ultimately shock. Exposure of the normally sterile peritoneal cavity to intraluminal contents causes secondary bacterial peritonitis. The peritoneal contamination due to bowel perforation is one of the leading risk factor for occurrence of burst abdomen [2].
Laparotomy wound dehiscence (LWD) is a term used to describe separation of the layers of a laparotomy wound before complete healing has taken place. Other terms used interchangeably are acute laparotomy wound failure and burst abdomen. Frequency of laparotomy wound dehiscence in the relevant literature is cited in the range of 0.2% to 10%[3,4]. The occurrence of fascial dehiscence represents a risk factor for increased mortality rates of up to 25%[5] [11] [12] Acute wound failure may be occult or overt, partial or complete. Overt wound failure follows early removal of sutures leading to evisceration. Occult dehiscence occurs with disruption of musculo-aponeurotic layer beneath intact skin sutures. Wound dehiscence has been noted to occur when a wound fails to gain sufficient strength to withstand stresses placed upon it. The separation may occur when overwhelming forces break sutures, when absorbable sutures dissolve too quickly or when tight sutures cut through tissues [6].
Conventional continuous closure technique has been shown to compromise blood supply and thereby poor wound holding, during initial phases of wound dehiscence. Surgeons have been continuously striving to overcome postoperative complications associated with laparotomy wound closure using newer techniques and newer suture materials. Several reviews have studied the optimal suture repair for closing the abdominal fascia, but no consensus has been reached. Hence, it is imperative for us to ascertain better method of closing the abdomen. While the choice may not be so important in elective patients who are nutritionally adequate, do not have any risk factor for dehiscence and are well prepared for surgery, however it may prove crucial in emergency patients who often have multiple risk factors for developing dehiscence and the strangulation of the sheath is the proverbial last straw in precipitating wound failure Majority of the studies suggest that, the most effective method of midline abdominal fascial closure in the elective setting is mass closure incorporating all layers of abdominal wall except skin in continuous technique with No. 1 or 2 delayed absorbable monofilament suture material with suture length to wound length ratio 4:14-7 .Many randomized controlled trials showed that odds of the burst abdomen are reduced with the interrupted method of closure as compared to continuous.
A study done by AGHARA CB et al8 to compare incidence of burst abdomen between modified smead-jones interrupted suture technique (2%) versus conventional continuous closure (14%) in patient undergoing hollow visus perforation. However the previous done studies have not taken into account a specific population with specific risk factor to compare these two suturing techniques so the aim of present study is to compare the incidence of burst abdomen in the patient undergoing midline abdominal wall closure with modified smead jones interrupted suture9 techniques (Experimental group) and conventional continuous suturing technique10 (Reference Group) in patient undergoing emergency laparotomy for hollow viscus perforation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomised control trials
| Arm | Type | Receives |
|---|---|---|
| Patient undergoing emergent laparotomy due to hollow viscus perforation | Experimental | Procedure: modified smead jones |
| patient undergoing emergent laparotomy | Experimental | Procedure: conventional comtinuous suture techniquespatient undergoing emergent laparotomy for hollow viscus perforation |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
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 |
|---|---|---|
| modified smead jonesinterrupted suture technique | Procedure or surgery | Patient undergoing emergent laparotomy due to hollow viscus perforation |
| conventional comtinuous suture techniquescontinuous suture technique | Procedure or surgery | patient undergoing emergent laparotomy |
Primary outcome
safety
Time frame: 15days after emergent laparotomy
best closure technique of rectus sheath
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 20 Nov 2024.
- Individual participant dataSharing planned: Undecided. still under consideration
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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.
Department of Surgery, King Edward Medical University
Lahore, Pakistan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing modified smead jones and conventional comtinuous suture techniques in people with Wound Dehiscence, Surgical, run by King Edward Medical University 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?
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: looking for participants now, as of the sponsor's last update on 20 Nov 2024. 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.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
safety (time frame: 15days after emergent laparotomy). 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 20 Nov 2024.