An interventional study of Monomax® 2/0 HR26 and Monomax® 1 HR48 in Abdominal Wall Defect, Abdominal Wall Hernia and Eventration, sponsored by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla. Status unknown at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-01-13.
Sponsored by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla · Not applicable, Interventional, and Prevention
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.
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.
82 studies on the registry are indexed under Hernia, Abdominal; 19 are open to participants now.
This study's planned enrollment of 105 is above the median of 90 across 48 interventional studies indexed under Hernia, Abdominal.
Browse Hernia, Abdominal studies →Fundación Pública Andaluza para la gestión de la Investigación en Sevilla is the lead sponsor of 120 studies on the registry; 26 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Procedure: Monomax® 2/0 HR26
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.
Procedure: Monomax® 1 HR48
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.
Also known as: 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.
Also known as: Suture
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.
Time frame: 1 year
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 1 year
Started Oct 2018 (actual). Primary completion is estimated for Dec 2021, 38 months after the start.
Of 31 interventional studies with no phase under Hernia, Abdominal, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 60. This study's planned 38 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.
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