Dehiscence of Laparotomy WoundShort-StitchNCT01938222
Short Stitch Monomax®
An observational study of Dehiscence of Laparotomy Wound and Surgical Wound Infection, run by Diakonie-Klinikum Schwäbisch Hall gGmbH at 1 site in Germany.
Trial summary
A number of studies identifies abdominal hernia as the most frequent postoperative complication following laparotomy with percentages of 9-20% - depending on duration of follow-up. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dehiscence of Laparotomy Wound, Surgical Wound Infection
- What is being tested?
- Short Stitch
- Type of treatment
- Surgery or procedure
- How many people
- 351 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2013to 7 Dec 2017
- Phase
- Observational
- 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
Study population: adult patients
Who may be able to join
- Age 18 years and older
- Primary elective and primary emergency laparotomy
- Written informed consent
Who cannot join
- Pregnant women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Controlled Monocentric Study Evaluating the 6:1 Suture Technique Using Suture Material Monomax® for Abdominal Wall Closure After Primary Abdominal Incision
A number of studies identifies abdominal hernia as the most frequent postoperative complication following laparotomy with percentages of 9-20% - depending on duration of follow-up. It is based on a multifactorial basis, including factors concerning individual, patient-specific factors, factors related to the operational technique as well as particular surgical factors. Wound complications have been reported by 7-12%, burst abdomen rate (dehiscence) < 5 days being 2-4%, wound infection rate (+/- wound dehiscence) ≥ 5 days being 6-10%. In emergency procedures (e.g. ileus, perforation of hollow organ) a wound complication rate of up to 50 % has to be expected. According to new, first findings from recent studies the rates of wound healing complication and burst abdomen can be reduced significantly. Depending on the study, to almost 50%. The principle is based on the reduction of the stitch length and type of the inserted suture. The stitches are closer and with less distance to the edge of fascia. Due to the much thinner suture it still comes here to a quantitative reduction of the inserted suture. The data collected using the MonoMax® suture in the short stitch technique will be compared to the results of the ISSAAC trial, in which the MonoMax® suture was used in the long stitch suture technique. The generated data are thus subject of retrospective comparison with a historical control group (ISSAAC study).
- Being tested
- Short Stitch
- Keywords
- abdominal wall closure, short stitch technique
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Short StitchProcedure or surgery
Also called MonoMax®
MonoMax® suture material USP (United States Pharmacopeia) 2/0, 150 cm, HR (half-round) 26 mm needle, will be applied in the short stitch technique (6:1) for abdominal wall closure.
| Study group | Role | What they receive |
|---|---|---|
| Short Stitch | Short stitch suture technique (6:1) for abdominal all closure stitch interval < 0,5 cm and lateral 0,5-0,8 cm Receives: Procedure: Short Stitch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound-infection rate until day of discharge according to CDC (Centre of Disease Control) Classification
Measured: until discharge (ca. 10 days after operation)
Secondary outcomes (4)
Reoperation rate due to burst abdomen until discharge
Measured: until discharge (ca. 10 days after operation)
Wound healing complications until discharge
Measured: until discharge (ca. 10 days after operation)
Length of postoperative hospital stay
Measured: until discharge (ca. 10 days after operation)
Use of the suture material (tissue drag, elasticity, knot security, knot pull tensile strength, knot run-down)
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2013 (estimated)
- Study startJan 2013
- Primary completion10 Nov 2017
- Study completion7 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Dehiscence of Laparotomy WoundStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 351 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diakonie-Klinikum Schwäbisch Hall gGmbH
- Sponsor type
- University, hospital or other
- Collaborators
- Aesculap AG
- Responsible party
- Sponsor
- Investigators
- Markus Golling, Prof., Principal investigator, Diakonie-Klinikum Schwäbisch Hall gGmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01938222
- Sponsor's protocol ID
- AAG-I-H-1203
- Acronym
- Short-Stitch
- Status last verified
- Mar 2024
- First submitted
- 26 Aug 2013
- Last updated
- 7 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
Golling M, Breul V, Zielska Z et al. 6:1 Suture or Wound length ratio with the short stitch technique - a reality check on practicability and short term outcome. Sur Res J. 2022;2(2).
Golling M, Breul V, Zielska Z, Baumann P. The 6:1 short stitch SL-WL-ratio: short term closure results of transverse and midline incisions in elective and emergency operations. Hernia. 2024 Apr;28(2):447-456. doi: 10.1007/s10029-023-02927-4. Epub 2024 Jan 29.
PubMed 38285168
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Controlled Monocentric Study Evaluating the 6:1 Suture Technique Using Suture Material Monomax® for Abdominal Wall Closure After Primary Abdominal Incision
- ClinicalTrials.gov ID
- NCT01938222
- Acronym / sponsor ID
- Short-Stitch / AAG-I-H-1203
- Keywords
- abdominal wall closure, short stitch technique
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 351 participants (actual)
- Lead sponsor
- Diakonie-Klinikum Schwäbisch Hall gGmbHUniversity, hospital or other
- Collaborators
- Aesculap AG
- Study start
- Jan 2013 (actual)
- Primary completion
- 10 Nov 2017 (actual)
- Study completion
- 7 Dec 2017 (actual)
- First posted
- 10 Sep 2013 (estimated)
- 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.
A number of studies identifies abdominal hernia as the most frequent postoperative complication following laparotomy with percentages of 9-20% - depending on duration of follow-up. It is based on a multifactorial basis, including factors concerning individual, patient-specific factors, factors related to the operational technique as well as particular surgical factors. Wound complications have been reported by 7-12%, burst abdomen rate (dehiscence) < 5 days being 2-4%, wound infection rate (+/- wound dehiscence) ≥ 5 days being 6-10%. In emergency procedures (e.g. ileus, perforation of hollow organ) a wound complication rate of up to 50 % has to be expected. According to new, first findings from recent studies the rates of wound healing complication and burst abdomen can be reduced significantly. Depending on the study, to almost 50%. The principle is based on the reduction of the stitch length and type of the inserted suture. The stitches are closer and with less distance to the edge of fascia. Due to the much thinner suture it still comes here to a quantitative reduction of the inserted suture. The data collected using the MonoMax® suture in the short stitch technique will be compared to the results of the ISSAAC trial, in which the MonoMax® suture was used in the long stitch suture technique. The generated data are thus subject of retrospective comparison with a historical control group (ISSAAC study).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Short Stitch | – | Procedure: Short StitchShort stitch suture technique (6:1) for abdominal all closure stitch interval < 0,5 cm and lateral 0,5-0,8 cm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- adult patients
Key inclusion criteria (3 listed)
- Age 18 years and older
- Primary elective and primary emergency laparotomy
- Written informed consent
Key exclusion criteria (1 listed)
- Pregnant women
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 |
|---|---|---|
| Short StitchAlso: MonoMax®MonoMax® suture material USP (United States Pharmacopeia) 2/0, 150 cm, HR (half-round) 26 mm needle, will be applied in the short stitch technique (6:1) for abdominal wall closure. | Procedure or surgery | Short Stitch |
Primary outcome
Wound-infection rate until day of discharge according to CDC (Centre of Disease Control) Classification
Time frame: until discharge (ca. 10 days after operation)
4 secondary outcomes
Reoperation rate due to burst abdomen until discharge
Time frame: until discharge (ca. 10 days after operation)
Wound healing complications until discharge
Time frame: until discharge (ca. 10 days after operation)
Length of postoperative hospital stay
Time frame: until discharge (ca. 10 days after operation)
Use of the suture material (tissue drag, elasticity, knot security, knot pull tensile strength, knot run-down)
Time frame: intraoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2024.
- BackgroundGolling M, Breul V, Zielska Z et al. 6:1 Suture or Wound length ratio with the short stitch technique - a reality check on practicability and short term outcome. Sur Res J. 2022;2(2).
- Results publication: PubMed 38285168Golling M, Breul V, Zielska Z, Baumann P. The 6:1 short stitch SL-WL-ratio: short term closure results of transverse and midline incisions in elective and emergency operations. Hernia. 2024 Apr;28(2):447-456. doi: 10.1007/s10029-023-02927-4. Epub 2024 Jan 29.
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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.
Markus Golling, Prof. principal investigator
Diakonie-Klinikum Schwäbisch Hall gGmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dehiscence of Laparotomy Wound and Surgical Wound Infection, run by Diakonie-Klinikum Schwäbisch Hall gGmbH at 1 site in Germany.
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 1 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: finished, as of the sponsor's last update on 7 Mar 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 Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Wound-infection rate until day of discharge according to CDC (Centre of Disease Control) Classification (time frame: until discharge (ca. 10 days after operation)). 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 NCT01938222, which also lists 2 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 7 Mar 2024; AzTrials last refreshed its copy on 26 Oct 2026.