Incision, SurgicalSBT-CMLNCT04788875
Small Bite Technique Versus Standardised Large Bites Technique in Closure of Midline Laparotomies.
A study testing Small bite suturing Technique and Standardised Large Bites Technique in people with Incision, Surgical and Suture, Complication, run by Imam Abdulrahman Bin Faisal University.
Trial summary
In the attempt to gain quick and complete access to the abdominal regions with the least damage to the nerves and the vascular structures, surgeons use the median laparotomy more frequently. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Incision, Surgical, Suture, Complication, Incisional Hernia
- What is being tested?
- Small bite suturing Technique and Standardised Large Bites Technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2021to 30 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Laparotomy through a midline incision
- Age more than 18
- BMI < 40
Who cannot join
- Previous incisional hernia or fascial dehiscence with secondary healing after a midline incision.
- Abdominal surgery through a midline incision within the last three months.
- Pregnancy.
- Patient on steroids and with genetic anomalies.
- Malignancy patients, next exposed to radiation therapy.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Small Bite Technique Versus Standardised Large Bites Technique in Closure of Midline Laparotomies: Randomised Control Trial.
In the attempt to gain quick and complete access to the abdominal regions with the least damage to the nerves and the vascular structures, surgeons use the median laparotomy more frequently. However, postoperative complications such as incisional hernia continue to be the known leading complications after median laparotomy. The reported cases to range from 2 to 20%. Higher cases have also been reported with up to 35% in the absence and aortic patients. Recent statistics have showed that small tissue bites prevent incisional hernia can occur in the aponeurosis. This technique is more effective than the commonly used process, which involves large edges of mass closure. In this study investigators aim to compare small bites sutures in closure of laparotomy incision and standardized large bites sutures, and its affect in reducing the incidence of incisional hernia postoperative along with the surgical site infection.
the investigators hypothesize that the small bites technique will result in a significant reduction of the incidence of incisional hernia and optimize the surgical site infection in major surgeries which may lead to a reduced morbidity and a better quality of life for patients and a significant reduction of costs.
Read the detailed description
Incisional hernia carries with life-threatening conditions such as the incarceration of bowel strangulation. However, incisional hernia remains the most common complication after median laparotomy, with reported incidences varying between 2-20%. Even higher incidences up to 30-35% have been reported in obese and aortic aneurysm patients. Incisional hernia also causes life impairment and discomfort. Median laparotomy and the incisional hernia have been under investigation for quite some time, and information about patients' risk factors and suture materials has been identified. However, the risk factors associated with suture techniques are not yet thoroughly investigated. Many clinical tests and analyses have concluded that a mass closure technique involving a simple running suture is the most effective way to prevent incisional hernia and close a midline incision. The method is also easy and fast to perform compared to other layered methods involving interrupted sutures. Use of natural materials that are thin resorbable materials decreases the occurrence of the incisional hernial and lower the intensity of preoperative pain and wound infections compared to the use of suture materials that are non-resorbable.
In this study the investigators aim to compare the small bites technique with a standardised large bites technique:
- Primary outcome:
- Incidence of Incisional Hernia postoperative.
- Pain scale.
- Secondary outcome:
- Quality of life, recovery, return to usual activity.
- Surgical site infection
- Time for closure. Study Design:
- Randomized Control Trial, Double blinded.
Study area\ sitting :
- The study will be conducted in King Fahad University Hospital, Khobar, Eastern Province, Saudi Arabia.
Sample size:
108 patients
Number of Arms (allocation):
2 Arms Arm1) Closure of laparotomy by small bites technique using PDS 2.0. Arm 2) Standardised large bites technique.
Randomisation technique:
Random.org
Blinding technique:
Double blinded. (patients and research recruiter) Follow up period: 6 months then 1 year, follow up by US.
Outcome expected to measure:
Study Subjects :
- Inclusion criteria:
- Laparotomy through a midline incision
- Age more than 18
- BMI < 40
- Exclusion criteria:
- Previous incisional hernia or fascial dehiscence with secondary healing after a midline incision.
- Abdominal surgery through a midline incision within the last three months.
- Pregnancy.
- Patient on steroids and with genetic anomalies.
- Malignancy patients, next exposed to radiation therapy.
Data Collection methods, instruments used, and measurements:
This research will include all patients who will had laparotomy through a midline incision according to our inclusion criteria, they will be randomised using computer generated numbers by using (Random.org), to either closure by small bites technique using PDS 2.0 or standardised large bites technique. The surgery will be done by either a consultant or a specialist following standard steps. A data sheet of each patient regarding their demographic, operation data, and postoperative recovery (pain, early mobilizing, wound healing, surgical site infection, retain to usual activity), then all patients will be followed for 6 month and 1 year postoperative by US, the endpoint is discovering of incisional hernia or not for 1 year follow up.
Data Management and analysis plan:
- SPSS will be used for data analysis.
- Summary statistic will be obtained as frequency, and percentage for qualitative data, and means, medians and standard deviations from continuous variables.
- Chi square test will be used to examine the significant difference of hernia rate between the two study group.
- T test will be used to examine the difference in the mean of pain post-operative between the two study group.
Ethical Considerations:
- Our study does not have any physical, psychological, social, legal, economic risk.
- The study will be reviewed by IRB, ethics committee; then the approval will be obtained.
- Written approval will be obtained from the patients prior to the procedure.
- Conditions
- Incision, Surgical, Suture, Complication, Incisional Hernia
- Being tested
- Small bite suturing Technique, Standardised Large Bites Technique
- Medical subject headings
- Surgical Wound, Incisional Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Small bite suturing TechniqueProcedure or surgery
Small bite suturing technique with PDS 2.0
Standardised Large Bites TechniqueProcedure or surgery
Standardised large bite suturing technique with PDS 2.0
| Study group | Role | What they receive |
|---|---|---|
| Small Bite Technique Group | Active comparator | closure of laparotomy by small bites technique using PDS 2.0 Receives: Procedure: Small bite suturing Technique |
| Standardised Large Bites Technique Group | Other | usual practice closure of laparotomy by standardised large bites technique using PDS 2.0 Receives: Procedure: Standardised Large Bites Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Incisional Hernia postoperative
Incidence of Incisional Hernia postoperative, will be assessed by using Ultra Sound.
Measured: Follow up on 6 month postoperative.
Incidence of Incisional Hernia postoperative
Incidence of Incisional Hernia postoperative, will be assessed by using Ultra Sound.
Measured: Follow up on 1 year postoperative.
Assessment of pain severity postoperative by pain scale
Assessment of pain scale post operative, lower score mean a better outcome.
Measured: Day 1 postoperative
Assessment of pain severity postoperative by pain scale
Assessment of pain scale post operative, lower score mean a better outcome.
Measured: Day 2 postoperative
Assessment of pain severity postoperative by pain scale
Assessment of pain scale post operative, lower score mean a better outcome.
Measured: Day 3 postoperative
Assessment of pain severity postoperative by pain scale
Assessment of pain scale post operative, lower score mean a better outcome.
Measured: Day 4 postoperative
Assessment of pain severity postoperative by pain scale
Assessment of pain scale post operative, lower score mean a better outcome.
Measured: Day 5 postoperative
Assessment of pain severity postoperative by pain scale
Assessment of pain scale post operative, lower score mean a better outcome.
Measured: Day 6 postoperative
Assessment of pain severity postoperative by pain scale
Assessment of pain scale post operative, lower score mean a better outcome.
Measured: Day 7 postoperative
Assessment of pain severity postoperative by pain scale
Assessment of pain scale post operative, lower score mean a better outcome.
Measured: Day 8 postoperative
Assessment of pain severity postoperative by pain scale
Assessment of pain scale post operative, lower score mean a better outcome.
Measured: Day 9 postoperative
Assessment of pain severity postoperative by pain scale
Assessment of pain scale post operative, lower score mean a better outcome.
Measured: Day 10 postoperative
Assessment of pain severity postoperative by pain scale
Assessment of pain scale post operative, lower score mean a better outcome.
Measured: Day 11 postoperative
Assessment of pain severity postoperative by pain scale
Assessment of pain scale post operative, lower score mean a better outcome.
Measured: Day 12 postoperative
Assessment of pain severity postoperative by pain scale
Assessment of pain scale post operative, lower score mean a better outcome.
Measured: Day 13 postoperative
Assessment of pain severity postoperative by pain scale
Assessment of pain scale post operative, lower score mean a better outcome.
Measured: Day 14 postoperative
Secondary outcomes (19)
Assessment of early mobilisation
When the patient started to mobilise? assessed by monitoring the patients postoperative and record when he started to mobilise.
Measured: Postoperative period, assessment in day1.
Assessment of early mobilisation
When the patient started to mobilise? assessed by monitoring the patients postoperative and record when he started to mobilise.
Measured: Postoperative period, assessment in day2.
Assessment of early mobilisation
When the patient started to mobilise? assessed by monitoring the patients postoperative and record when he started to mobilise.
Measured: Postoperative period, assessment in day3.
Retain to work (how many days between surgery and patient back to his work)
When the patient back to his work or usual activity? assessed by monitoring the patients postoperative and record when he started to work again.
Measured: up to 6 weeks, postoperative period from discharge until day patient back to work.
Surgical site infection of the wound postoperative
Surgical site infection of the wound postoperative, if there is any sign of surgical site infection, itching, discharge, redness, fever, collection.
Measured: day 1 postoprtaive.
Surgical site infection of the wound postoperative
Surgical site infection of the wound postoperative, if there is any sign of surgical site infection, itching, discharge, redness, fever, collection.
Measured: day 2 postoprtaive.
Surgical site infection of the wound postoperative
Surgical site infection of the wound postoperative, if there is any sign of surgical site infection, itching, discharge, redness, fever, collection.
Measured: day 3 postoprtaive.
Surgical site infection of the wound postoperative
Surgical site infection of the wound postoperative, if there is any sign of surgical site infection, itching, discharge, redness, fever, collection.
Measured: day 4 postoprtaive.
Surgical site infection of the wound postoperative
Surgical site infection of the wound postoperative, if there is any sign of surgical site infection, itching, discharge, redness, fever, collection.
Measured: day 5 postoprtaive.
Surgical site infection of the wound postoperative
Surgical site infection of the wound postoperative, if there is any sign of surgical site infection, itching, discharge, redness, fever, collection.
Measured: day 6 postoprtaive.
Surgical site infection of the wound postoperative
Surgical site infection of the wound postoperative, if there is any sign of surgical site infection, itching, discharge, redness, fever, collection.
Measured: day 7 postoprtaive.
Surgical site infection of the wound postoperative
Surgical site infection of the wound postoperative, if there is any sign of surgical site infection, itching, discharge, redness, fever, collection.
Measured: day 8 postoprtaive.
Surgical site infection of the wound postoperative
Surgical site infection of the wound postoperative, if there is any sign of surgical site infection, itching, discharge, redness, fever, collection.
Measured: day 9 postoprtaive.
Surgical site infection of the wound postoperative
Surgical site infection of the wound postoperative, if there is any sign of surgical site infection, itching, discharge, redness, fever, collection.
Measured: day 10 postoprtaive.
Surgical site infection of the wound postoperative
Surgical site infection of the wound postoperative, if there is any sign of surgical site infection, itching, discharge, redness, fever, collection.
Measured: day 11 postoprtaive.
Surgical site infection of the wound postoperative
Surgical site infection of the wound postoperative, if there is any sign of surgical site infection, itching, discharge, redness, fever, collection.
Measured: day 12 postoprtaive.
Surgical site infection of the wound postoperative
Surgical site infection of the wound postoperative, if there is any sign of surgical site infection, itching, discharge, redness, fever, collection.
Measured: day 13 postoprtaive.
Surgical site infection of the wound postoperative
Surgical site infection of the wound postoperative, if there is any sign of surgical site infection, itching, discharge, redness, fever, collection.
Measured: day 14 postoprtaive.
Time taken in closure of laparotomy incision (in minutes)
Time taken for closure of the laparotomy incision, there will be timer, started from the beginning of suturing the laparotomy incision till the end. (in minutes)
Measured: intraoperative (through the closure of the laparotomy incision inside the operation room, suturing time (start to end) in minutes . (how many minutes surgeon took in suturing the incision))
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2021
- Study start1 Dec 2021 (estimated)
- Primary completion30 Nov 2023 (estimated)
- Study completion30 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Incision, 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
- 2 Arms Arm1) Closure of laparotomy by small bites technique using PDS 2.0 Arm2) Closure of laparotomy by standardised large bites technique This research will include all patients who will had laparotomy through a midline incision according to our inclusion criteria, they will be randomised using computer generated numbers by using (Random.org), to either closure by small bites technique using PDS 2.0 or standardised large bites technique.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imam Abdulrahman Bin Faisal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nasser Mohamed Amer, Imam Abdulrahman Bin Faisal University
- Investigators
- Nasser M Amer, Principal investigator, Imam Abdulrahman Bin Faisal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04788875
- Sponsor's protocol ID
- SBT-CML
- Acronym
- SBT-CML
- Status last verified
- Oct 2021
- First submitted
- 9 Feb 2021
- Last updated
- 8 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Small Bite Technique Versus Standardised Large Bites Technique in Closure of Midline Laparotomies: Randomised Control Trial.
- ClinicalTrials.gov ID
- NCT04788875
- Acronym / sponsor ID
- SBT-CML / SBT-CML
- Conditions
- Incision, Surgical, Suture, Complication, Incisional Hernia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Imam Abdulrahman Bin Faisal UniversityUniversity, hospital or other
- Study start
- 1 Dec 2021 (estimated)
- Primary completion
- 30 Nov 2023 (estimated)
- Study completion
- 30 Nov 2023 (estimated)
- First posted
- 9 Mar 2021 (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.
In the attempt to gain quick and complete access to the abdominal regions with the least damage to the nerves and the vascular structures, surgeons use the median laparotomy more frequently. However, postoperative complications such as incisional hernia continue to be the known leading complications after median laparotomy. The reported cases to range from 2 to 20%. Higher cases have also been reported with up to 35% in the absence and aortic patients. Recent statistics have showed that small tissue bites prevent incisional hernia can occur in the aponeurosis. This technique is more effective than the commonly used process, which involves large edges of mass closure. In this study investigators aim to compare small bites sutures in closure of laparotomy incision and standardized large bites sutures, and its affect in reducing the incidence of incisional hernia postoperative along with the surgical site infection.
the investigators hypothesize that the small bites technique will result in a significant reduction of the incidence of incisional hernia and optimize the surgical site infection in major surgeries which may lead to a reduced morbidity and a better quality of life for patients and a significant reduction of costs.
Detailed description
Incisional hernia carries with life-threatening conditions such as the incarceration of bowel strangulation. However, incisional hernia remains the most common complication after median laparotomy, with reported incidences varying between 2-20%. Even higher incidences up to 30-35% have been reported in obese and aortic aneurysm patients. Incisional hernia also causes life impairment and discomfort. Median laparotomy and the incisional hernia have been under investigation for quite some time, and information about patients' risk factors and suture materials has been identified. However, the risk factors associated with suture techniques are not yet thoroughly investigated. Many clinical tests and analyses have concluded that a mass closure technique involving a simple running suture is the most effective way to prevent incisional hernia and close a midline incision. The method is also easy and fast to perform compared to other layered methods involving interrupted sutures. Use of natural materials that are thin resorbable materials decreases the occurrence of the incisional hernial and lower the intensity of preoperative pain and wound infections compared to the use of suture materials that are non-resorbable.
In this study the investigators aim to compare the small bites technique with a standardised large bites technique:
- Primary outcome:
- Incidence of Incisional Hernia postoperative.
- Pain scale.
- Secondary outcome:
- Quality of life, recovery, return to usual activity.
- Surgical site infection
- Time for closure. Study Design:
- Randomized Control Trial, Double blinded.
Study area\ sitting :
- The study will be conducted in King Fahad University Hospital, Khobar, Eastern Province, Saudi Arabia.
Sample size:
108 patients
Number of Arms (allocation):
2 Arms Arm1) Closure of laparotomy by small bites technique using PDS 2.0. Arm 2) Standardised large bites technique.
Randomisation technique:
Random.org
Blinding technique:
Double blinded. (patients and research recruiter) Follow up period: 6 months then 1 year, follow up by US.
Outcome expected to measure:
Study Subjects :
- Inclusion criteria:
- Laparotomy through a midline incision
- Age more than 18
- BMI < 40
- Exclusion criteria:
- Previous incisional hernia or fascial dehiscence with secondary healing after a midline incision.
- Abdominal surgery through a midline incision within the last three months.
- Pregnancy.
- Patient on steroids and with genetic anomalies.
- Malignancy patients, next exposed to radiation therapy.
Data Collection methods, instruments used, and measurements:
This research will include all patients who will had laparotomy through a midline incision according to our inclusion criteria, they will be randomised using computer generated numbers by using (Random.org), to either closure by small bites technique using PDS 2.0 or standardised large bites technique. The surgery will be done by either a consultant or a specialist following standard steps. A data sheet of each patient regarding their demographic, operation data, and postoperative recovery (pain, early mobilizing, wound healing, surgical site infection, retain to usual activity), then all patients will be followed for 6 month and 1 year postoperative by US, the endpoint is discovering of incisional hernia or not for 1 year follow up.
Data Management and analysis plan:
- SPSS will be used for data analysis.
- Summary statistic will be obtained as frequency, and percentage for qualitative data, and means, medians and standard deviations from continuous variables.
- Chi square test will be used to examine the significant difference of hernia rate between the two study group.
- T test will be used to examine the difference in the mean of pain post-operative between the two study group.
Ethical Considerations:
- Our study does not have any physical, psychological, social, legal, economic risk.
- The study will be reviewed by IRB, ethics committee; then the approval will be obtained.
- Written approval will be obtained from the patients prior to the procedure.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- 2 Arms Arm1) Closure of laparotomy by small bites technique using PDS 2.0 Arm2) Closure of laparotomy by standardised large bites technique This research will include all patients who will had laparotomy through a midline incision according to our inclusion criteria, they will be randomised using computer generated numbers by using (Random.org), to either closure by small bites technique using PDS 2.0 or standardised large bites technique.
| Arm | Type | Receives |
|---|---|---|
| Small Bite Technique Group | Active comparator | Procedure: Small bite suturing Techniqueclosure of laparotomy by small bites technique using PDS 2.0 |
| Standardised Large Bites Technique Group | Other | Procedure: Standardised Large Bites Techniqueusual practice closure of laparotomy by standardised large bites technique using PDS 2.0 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Laparotomy through a midline incision
- Age more than 18
- BMI < 40
Key exclusion criteria (5 listed)
- Previous incisional hernia or fascial dehiscence with secondary healing after a midline incision.
- Abdominal surgery through a midline incision within the last three months.
- Pregnancy.
- Patient on steroids and with genetic anomalies.
- Malignancy patients, next exposed to radiation therapy.
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 suturing TechniqueSmall bite suturing technique with PDS 2.0 | Procedure or surgery | Small Bite Technique Group |
| Standardised Large Bites TechniqueStandardised large bite suturing technique with PDS 2.0 | Procedure or surgery | Standardised Large Bites Technique Group |
Primary outcome
Incidence of Incisional Hernia postoperative
Time frame: Follow up on 6 month postoperative.
Incidence of Incisional Hernia postoperative, will be assessed by using Ultra Sound.
Incidence of Incisional Hernia postoperative
Time frame: Follow up on 1 year postoperative.
Incidence of Incisional Hernia postoperative, will be assessed by using Ultra Sound.
Assessment of pain severity postoperative by pain scale
Time frame: Day 1 postoperative
Assessment of pain scale post operative, lower score mean a better outcome.
Assessment of pain severity postoperative by pain scale
Time frame: Day 2 postoperative
Assessment of pain scale post operative, lower score mean a better outcome.
Assessment of pain severity postoperative by pain scale
Time frame: Day 3 postoperative
Assessment of pain scale post operative, lower score mean a better outcome.
Assessment of pain severity postoperative by pain scale
Time frame: Day 4 postoperative
Assessment of pain scale post operative, lower score mean a better outcome.
Assessment of pain severity postoperative by pain scale
Time frame: Day 5 postoperative
Assessment of pain scale post operative, lower score mean a better outcome.
Assessment of pain severity postoperative by pain scale
Time frame: Day 6 postoperative
Assessment of pain scale post operative, lower score mean a better outcome.
Assessment of pain severity postoperative by pain scale
Time frame: Day 7 postoperative
Assessment of pain scale post operative, lower score mean a better outcome.
Assessment of pain severity postoperative by pain scale
Time frame: Day 8 postoperative
Assessment of pain scale post operative, lower score mean a better outcome.
Assessment of pain severity postoperative by pain scale
Time frame: Day 9 postoperative
Assessment of pain scale post operative, lower score mean a better outcome.
Assessment of pain severity postoperative by pain scale
Time frame: Day 10 postoperative
Assessment of pain scale post operative, lower score mean a better outcome.
Assessment of pain severity postoperative by pain scale
Time frame: Day 11 postoperative
Assessment of pain scale post operative, lower score mean a better outcome.
Assessment of pain severity postoperative by pain scale
Time frame: Day 12 postoperative
Assessment of pain scale post operative, lower score mean a better outcome.
Assessment of pain severity postoperative by pain scale
Time frame: Day 13 postoperative
Assessment of pain scale post operative, lower score mean a better outcome.
Assessment of pain severity postoperative by pain scale
Time frame: Day 14 postoperative
Assessment of pain scale post operative, lower score mean a better outcome.
19 secondary outcomes
Assessment of early mobilisation
Time frame: Postoperative period, assessment in day1.
Assessment of early mobilisation
Time frame: Postoperative period, assessment in day2.
Assessment of early mobilisation
Time frame: Postoperative period, assessment in day3.
Retain to work (how many days between surgery and patient back to his work)
Time frame: up to 6 weeks, postoperative period from discharge until day patient back to work.
Surgical site infection of the wound postoperative
Time frame: day 1 postoprtaive.
Surgical site infection of the wound postoperative
Time frame: day 2 postoprtaive.
Surgical site infection of the wound postoperative
Time frame: day 3 postoprtaive.
Surgical site infection of the wound postoperative
Time frame: day 4 postoprtaive.
Surgical site infection of the wound postoperative
Time frame: day 5 postoprtaive.
Surgical site infection of the wound postoperative
Time frame: day 6 postoprtaive.
Surgical site infection of the wound postoperative
Time frame: day 7 postoprtaive.
Surgical site infection of the wound postoperative
Time frame: day 8 postoprtaive.
Surgical site infection of the wound postoperative
Time frame: day 9 postoprtaive.
Surgical site infection of the wound postoperative
Time frame: day 10 postoprtaive.
Surgical site infection of the wound postoperative
Time frame: day 11 postoprtaive.
Surgical site infection of the wound postoperative
Time frame: day 12 postoprtaive.
Surgical site infection of the wound postoperative
Time frame: day 13 postoprtaive.
Surgical site infection of the wound postoperative
Time frame: day 14 postoprtaive.
Time taken in closure of laparotomy incision (in minutes)
Time frame: intraoperative (through the closure of the laparotomy incision inside the operation room, suturing time (start to end) in minutes . (how many minutes surgeon took in suturing the incision))
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2021.
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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.
Nasser M Amer principal investigator
Imam Abdulrahman Bin Faisal University
Questions about this trial
What is this clinical trial studying?
A study testing Small bite suturing Technique and Standardised Large Bites Technique in people with Incision, Surgical and Suture, Complication, run by Imam Abdulrahman Bin Faisal University.
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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 8 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nasser M Amer (00966 53 865 9290, nmamer@iau.edu.sa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Incisional Hernia postoperative (time frame: Follow up on 6 month postoperative.). The study lists 16 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 8 Nov 2021.