Abdominal Wall DefectSTCUNCT03765060
The Efficacy and Security of the Small Stitch Technique in Emergency Surgery
A study testing Monomax® 2/0 HR26 and Monomax® 1 HR48 in people with Abdominal Wall Defect and Abdominal Wall Hernia, run by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla at 1 site in Spain.
Trial summary
This study evaluates the abdominal closure technique in emergency surgery. Half of participants will be perform the classic Large Stitch technique, while the other half will undergo the Small Stitch technique. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abdominal Wall Defect, Abdominal Wall Hernia, Eventration
- What is being tested?
- Monomax® 2/0 HR26 and Monomax® 1 HR48
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteSpain
- Study dates
- 1 Oct 2018to 1 Dec 2021
- 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
- Patients over 18 years of age and who provide informed consent to participate in the study.
- Patients requiring an urgent midline laparotomy with a minimum size of 8 cm.
Who cannot join
- Prior midline laparotomy.
- Patients with BMI> 45 kg / m2
- Patients with ASA (American Society of Anesthesiologists)> IV.
- Patient with an advanced terminal illness with an expectation of life <1 year.
- Patients with abdominal aortic aneurysm.
- Patients with coagulopathy: patient previously diagnosed with von Willebrand disease, hemophilia or Immune thrombocytopenic purpura.
Show all 12Show fewer
- Immunosuppressed patient: HIV patients in the AIDS phase, chronic corticosteroid or immunosuppressive treatment.
- Patients with collagen pathology: patient previously diagnosed with Marfan syndrome, Ehlers-Danlos syndrome, homocystinuria and scleroderma.
- Chemotherapeutic treatment 2 weeks before surgery.
- Radiotherapy treatment 6 weeks before surgery.
- Diffuse peritonitis with hemodynamic instability, defined by non-response to fluids prior to surgery or during the surgical process.
- Pregnant or potentially fertile women, breastfeeding, or intention to become pregnant, or those who do not wish to use effective contraception (hormonal contraceptives (implantation, patches, oral), and double barrier methods (any double combination of: IUD (intrauterine device), male or female prophylactics with spermicidal gel, diaphragm, contraceptive sponge, cervical cap).
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario Virgen Del Rocio
Seville, 41013
Mª Jesús Tamayo lópez, PhD, 34955013414, mtamayolopez@gmail.com
Luis Tallón Aguilar, ltallona@hotmail.com
About this study
Official title: Clinical Trial on the Efficacy and Security of the Small Stitch Technique Versus the Large Stitch Closure Laparotomy Technique in Emergency Surgery
This study evaluates the abdominal closure technique in emergency surgery. Half of participants will be perform the classic Large Stitch technique, while the other half will undergo the Small Stitch technique.
Read the detailed description
The closure of laparotomy is one of the most important challenges facing the surgeon.
The classic technique of wall closure is the Large Stitch technique that uses monofilament double-strand sutures with a SL/WL (Suture Lengh/Wound Lengh) 4:1 ratio, with a distance to the alba line and between each stitch of 1 cm.
Nowadays, the Small Stitch technique is accepted as the technique of choice for closure of laparotomies in programmed surgery. It is based on a very long-term monofilament absorbable synthetic suture of Poly-4-hydroxybutyrate (Monomax) 2/0 with HR (Half-circle Round body) 26 needle. Stitches should be given with a distance to the alba line of 0'5cm and 0'5 cm of separation between stitches.
There are very few studies about the role of Small Stitch technique in the field of Emergency Surgery where the increased morbidity of the patient and the higher rate of surgical wound infection can play a fundamental role, and could be improved with the use of new abdominal wall closure techniques.
- Being tested
- Monomax® 2/0 HR26, Monomax® 1 HR48
- Medical subject headings
- Hernia, Abdominal, Gastroschisis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monomax® 2/0 HR26Procedure or surgery
Also called Suture
It will be use a very long-term monofilament absorbable synthetic suture of Poly-4-hydroxybutyrate (Monomax) 2/0 with HR 26 needle.
In the technique should be given at least 2 points for each wound cm, with a distance to the alba line of 0'5cm and 0'5 cm of separation between stitches. The closure starts from both ends, ending in the middle of the laparotomy with an overlap of at least 2 cm. The ratio between the length of the suture and the length of the wound should be at least 4:1.
Monomax® 1 HR48Procedure or surgery
Also called Suture
It will be use a very long-term monofilament absorbable synthetic suture of Poly-4-hydroxybutyrate (Monomax) 1 with HR 48 needle.
In the technique should be given 1 point for each wound cm, with a distance to the alba line of 1 cm and 1 cm of separation between stitches. The closure starts from both ends, ending in the middle of the laparotomy with an overlap of at least 2 cm. The ratio between the length of the suture and the length of the wound should be at least 4:1.
| Study group | Role | What they receive |
|---|---|---|
| Small Stitch | Experimental | Patients requiring an urgent emergency laparotomy. The Small Stitch closure technique will be perform using a Monomax® 2/0 HR26 (Half-circle Round body):
* It will be use a very long-term monofilament absorbable synthetic suture of Poly-4-hydroxybutyrate (Monomax) 2/0 with HR 26 needle (Half-circle Round body).
* In the technique should be given at least 2 points for each wound cm, with a distance to the alba line of 0'5cm and 0'5 cm of separation between stitches. The closure starts from both ends, ending in the middle of the laparotomy with an overlap of at least 2 cm. The ratio between the length of the suture and the length of the wound should be at least 4:1. Receives: Procedure: Monomax® 2/0 HR26 |
| Large Stitch | Active comparator | The intervention will be the classic large Stitch closure technique using a Monomax® 1 HR48 (Half-circle Round body).
* It will be use a very long-term monofilament absorbable synthetic suture of Poly-4-hydroxybutyrate (Monomax) 1 with HR 48 needle (Half-circle Round body).
* In the technique should be given 1 point for each wound cm, with a distance to the alba line of 1 cm and 1 cm of separation between stitches. The closure starts from both ends, ending in the middle of the laparotomy with an overlap of at least 2 cm. The ratio between the length of the suture and the length of the wound should be at least 4:1. Receives: Procedure: Monomax® 1 HR48 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of the small stitch technique defined by eventration rate
To determine the efficacy of the "Small stitch" technique versus the "Large Stitch" technique in the closure of midline laparotomy with respect to the production of eventration in patients undergoing urgent abdominal surgery.
Measured: 1 year
Secondary outcomes (4)
Efficacy of the small stitch technique defined by local complications rate
To determine whether the closure of midline laparotomy with the "Small Stitch" technique in patients undergoing urgent abdominal surgery reduces the local complications of the surgical wound defined by hematoma, seroma or wound infection.
Measured: 1 year
Efficacy of the small stitch technique defined by evisceration rate
To determine if the closure of the midline laparotomy with the "Small Stitch" technique in patients undergoing urgent abdominal surgery reduces the rate of evisceration.
Measured: 1 year
Efficacy of the small stitch technique defined by improvement of quality of life
To determine if the closure of a midline laparotomy with the "Small Stitch" technique in patients undergoing urgent abdominal surgery improves the quality of life.
Measured: 1 year
Security of the small stitch technique
To determine the safety of the Small Stitch technique versus the "Large Stitch" technique in the closure of the midline laparotomy with respect to the incidence of adverse events and serious adverse events, the incidence of side effects related to the treatment and the incidence and the reasons for premature withdrawal of premature patient from the study.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2018
- Study start1 Oct 2018
- Primary completion1 Dec 2021 (estimated)
- Study completion1 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Abdominal Wall DefectStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tamayo López María Jesús, PhD, Principal investigator, Hospitales Universitarios Virgen del RocíoPadillo Ruiz Francisco Javier, PhD, Study director, Hospitales Universitarios Virgen del Rocío
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03765060
- Sponsor's protocol ID
- SL-Stitch
- Acronym
- STCU
- Status last verified
- Dec 2020
- First submitted
- 8 Aug 2018
- Last updated
- 13 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Israelsson LA, Millbourn D. Closing midline abdominal incisions. Langenbecks Arch Surg. 2012 Dec;397(8):1201-7. doi: 10.1007/s00423-012-1019-4. Epub 2012 Nov 11.
PubMed 23143146Millbourn D, Cengiz Y, Israelsson LA. Risk factors for wound complications in midline abdominal incisions related to the size of stitches. Hernia. 2011 Jun;15(3):261-6. doi: 10.1007/s10029-010-0775-8. Epub 2011 Jan 30.
PubMed 21279664Millbourn D, Wimo A, Israelsson LA. Cost analysis of the use of small stitches when closing midline abdominal incisions. Hernia. 2014;18(6):775-80. doi: 10.1007/s10029-013-1135-2. Epub 2013 Jul 10.
PubMed 23839330O'Dwyer PJ, Courtney CA. Factors involved in abdominal wall closure and subsequent incisional hernia. Surgeon. 2003 Feb;1(1):17-22. doi: 10.1016/s1479-666x(03)80004-5.
PubMed 15568420Israelsson LA, Jonsson T. Suture length to wound length ratio and healing of midline laparotomy incisions. Br J Surg. 1993 Oct;80(10):1284-6. doi: 10.1002/bjs.1800801020.
PubMed 8242299
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial on the Efficacy and Security of the Small Stitch Technique Versus the Large Stitch Closure Laparotomy Technique in Emergency Surgery
- ClinicalTrials.gov ID
- NCT03765060
- Acronym / sponsor ID
- STCU / SL-Stitch
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Fundación Pública Andaluza para la gestión de la Investigación en SevillaUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 1 Dec 2021 (estimated)
- First posted
- 5 Dec 2018 (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.
This study evaluates the abdominal closure technique in emergency surgery. Half of participants will be perform the classic Large Stitch technique, while the other half will undergo the Small Stitch technique.
Detailed description
The closure of laparotomy is one of the most important challenges facing the surgeon.
The classic technique of wall closure is the Large Stitch technique that uses monofilament double-strand sutures with a SL/WL (Suture Lengh/Wound Lengh) 4:1 ratio, with a distance to the alba line and between each stitch of 1 cm.
Nowadays, the Small Stitch technique is accepted as the technique of choice for closure of laparotomies in programmed surgery. It is based on a very long-term monofilament absorbable synthetic suture of Poly-4-hydroxybutyrate (Monomax) 2/0 with HR (Half-circle Round body) 26 needle. Stitches should be given with a distance to the alba line of 0'5cm and 0'5 cm of separation between stitches.
There are very few studies about the role of Small Stitch technique in the field of Emergency Surgery where the increased morbidity of the patient and the higher rate of surgical wound infection can play a fundamental role, and could be improved with the use of new abdominal wall closure techniques.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Small Stitch | Experimental | Procedure: Monomax® 2/0 HR26Patients requiring an urgent emergency laparotomy. The Small Stitch closure technique will be perform using a Monomax® 2/0 HR26 (Half-circle Round body): * It will be use a very long-term monofilament absorbable synthetic suture of Poly-4-hydroxybutyrate (Monomax) 2/0 with HR 26 needle (Half-circle Round body). * In the technique should be given at least 2 points for each wound cm, with a distance to the alba line of 0'5cm and 0'5 cm of separation between stitches. The closure starts from both ends, ending in the middle of the laparotomy with an overlap of at least 2 cm. The ratio between the length of the suture and the length of the wound should be at least 4:1. |
| Large Stitch | Active comparator | Procedure: Monomax® 1 HR48The intervention will be the classic large Stitch closure technique using a Monomax® 1 HR48 (Half-circle Round body). * It will be use a very long-term monofilament absorbable synthetic suture of Poly-4-hydroxybutyrate (Monomax) 1 with HR 48 needle (Half-circle Round body). * In the technique should be given 1 point for each wound cm, with a distance to the alba line of 1 cm and 1 cm of separation between stitches. The closure starts from both ends, ending in the middle of the laparotomy with an overlap of at least 2 cm. The ratio between the length of the suture and the length of the wound should be at least 4:1. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients over 18 years of age and who provide informed consent to participate in the study.
- Patients requiring an urgent midline laparotomy with a minimum size of 8 cm.
Key exclusion criteria (12 listed)
- Prior midline laparotomy.
- Patients with BMI> 45 kg / m2
- Patients with ASA (American Society of Anesthesiologists)> IV.
- Patient with an advanced terminal illness with an expectation of life <1 year.
- Patients with abdominal aortic aneurysm.
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 |
|---|---|---|
| Monomax® 2/0 HR26Also: SutureIt will be use a very long-term monofilament absorbable synthetic suture of Poly-4-hydroxybutyrate (Monomax) 2/0 with HR 26 needle. In the technique should be given at least 2 points for each wound cm, with a distance to the alba line of 0'5cm and 0'5 cm of separation between stitches. The closure starts from both ends, ending in the middle of the laparotomy with an overlap of at least 2 cm. The ratio between the length of the suture and the length of the wound should be at least 4:1. | Procedure or surgery | Small Stitch |
| Monomax® 1 HR48Also: SutureIt will be use a very long-term monofilament absorbable synthetic suture of Poly-4-hydroxybutyrate (Monomax) 1 with HR 48 needle. In the technique should be given 1 point for each wound cm, with a distance to the alba line of 1 cm and 1 cm of separation between stitches. The closure starts from both ends, ending in the middle of the laparotomy with an overlap of at least 2 cm. The ratio between the length of the suture and the length of the wound should be at least 4:1. | Procedure or surgery | Large Stitch |
Primary outcome
Efficacy of the small stitch technique defined by eventration rate
Time frame: 1 year
To determine the efficacy of the "Small stitch" technique versus the "Large Stitch" technique in the closure of midline laparotomy with respect to the production of eventration in patients undergoing urgent abdominal surgery.
4 secondary outcomes
Efficacy of the small stitch technique defined by local complications rate
Time frame: 1 year
Efficacy of the small stitch technique defined by evisceration rate
Time frame: 1 year
Efficacy of the small stitch technique defined by improvement of quality of life
Time frame: 1 year
Security of the small stitch technique
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2021.
- Background: PubMed 23143146Israelsson LA, Millbourn D. Closing midline abdominal incisions. Langenbecks Arch Surg. 2012 Dec;397(8):1201-7. doi: 10.1007/s00423-012-1019-4. Epub 2012 Nov 11.
- Background: PubMed 21279664Millbourn D, Cengiz Y, Israelsson LA. Risk factors for wound complications in midline abdominal incisions related to the size of stitches. Hernia. 2011 Jun;15(3):261-6. doi: 10.1007/s10029-010-0775-8. Epub 2011 Jan 30.
- Background: PubMed 23839330Millbourn D, Wimo A, Israelsson LA. Cost analysis of the use of small stitches when closing midline abdominal incisions. Hernia. 2014;18(6):775-80. doi: 10.1007/s10029-013-1135-2. Epub 2013 Jul 10.
- Background: PubMed 15568420O'Dwyer PJ, Courtney CA. Factors involved in abdominal wall closure and subsequent incisional hernia. Surgeon. 2003 Feb;1(1):17-22. doi: 10.1016/s1479-666x(03)80004-5.
- Background: PubMed 8242299Israelsson LA, Jonsson T. Suture length to wound length ratio and healing of midline laparotomy incisions. Br J Surg. 1993 Oct;80(10):1284-6. doi: 10.1002/bjs.1800801020.
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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.
Tamayo López María Jesús, PhD principal investigator
Hospitales Universitarios Virgen del Rocío
Padillo Ruiz Francisco Javier, PhD study director
Hospitales Universitarios Virgen del Rocío
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Monomax® 2/0 HR26 and Monomax® 1 HR48 in people with Abdominal Wall Defect and Abdominal Wall Hernia, run by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla at 1 site in Spain.
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 12 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 13 Jan 2021. 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 Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tamayo López María Jesús, PhD (686589986, mtamayolopez@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of the small stitch technique defined by eventration rate (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03765060, which also lists 5 linked publications.
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 13 Jan 2021.