Cesarean SectionNCT04302597
Cosmetic Outcomes With Tissue Adhesive (2-octylcyanoacrylate) or Staples in Repeated Cesarean Section
A study testing Staples and Tissue adhesive in people with Cesarean Section, run by Università degli Studi dell'Insubria at 1 site in Italy.
Trial summary
Recent clinical trials were developed to test the outcomes of skin closure with tissue adhesive, staples and monofilament synthetic suture after cesarean section with Pfannenstiel incision: both clinical outcomes such as blood loss, surgical site infection, length of postpartum hospitalization, or wound disruption, as… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Cesarean Section
- What is being tested?
- Staples and Tissue adhesive
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteItaly
- Study dates
- 15 May 2020to 15 Jul 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 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Previous cesarean section with Pfannenstiel incision (regardless of the indication, emergency/urgency, weeks of pregnancy and years passed from the previous cesarean section)
- Maternal age 18-45 years
- Singleton pregnancy at 37-41 weeks of gestation (based on first-trimester ultrasound) with a viable fetus
Who cannot join
- History of keloids
- Previous transversal suprapubic scars
- Clinical signs of infection and/or tattoos in the area to be studied
- Known patient hypersensitivity to any of the suture materials used in the protocol
- BMI below 20 or above 30
- Any medical disorder that could affect wound healing, including severe malnutrition, conditions requiring chronic corticosteroid use or immune suppressant, uncontrolled diabetes mellitus (defined as Hemoglobin A1c > 6%, unbalanced daily glucose measurements, and fasting glucose >95 mg/dL).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cosmetic Outcomes After Skin Closure of Pfannenstiel Incision With Tissue Adhesive (2-octylcyanoacrylate) or Staples in Repeated Cesarean Section
Recent clinical trials were developed to test the outcomes of skin closure with tissue adhesive, staples and monofilament synthetic suture after cesarean section with Pfannenstiel incision: both clinical outcomes such as blood loss, surgical site infection, length of postpartum hospitalization, or wound disruption, as well as Patient and Observer Scar Assessment Scale (POSAS) scores 8 weeks after surgery, were comparable between these different skin closure methods.
Despite the available studies are often based on robust methodologies and appropriate assessment scales, most of them were aimed to evaluate cosmetic outcomes in primary cesarean section, whereas data analyses published so far do not allow to draw a firm conclusion about repeated cesarean sections. Based on these elements, the aim of this study is to evaluate cosmetic outcomes after skin closure of Pfannenstiel incision with tissue adhesive or staples in a selected population undergoing repeated cesarean section.
- Conditions
- Cesarean Section
- Being tested
- Staples, Tissue adhesive
- Keywords
- Cesarean delivery, Cosmesis, Healing, Skin closure, Scar assessment scales
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StaplesProcedure or surgery
Skin closure using surgical stapler.
Tissue adhesiveProcedure or surgery
Skin closure using 2-octylcyanoacrylate tissue adhesive.
| Study group | Role | What they receive |
|---|---|---|
| Staples | Active comparator | Women who underwent repeated cesarean section with skin closure using staples. Receives: Procedure: Staples |
| Tissue adhesive | Experimental | Women who underwent repeated cesarean section with skin closure using 2-octylcyanoacrylate tissue adhesive. Receives: Procedure: Tissue adhesive |
What is being measured
The primary outcome is the main question the study is designed to answer.
Observer Scar Assessment Scale (OSAS) score
The Observer Scar Assessment Scale (OSAS) rates 5 variables: vascularity, pigmentation, thickness, relief, and pliability. Each variable uses a 10-point scoring system, with 1 representing normal skin. Ratings of individual variables may be summed to obtain a total score ranging from 5-50, with 5 representing normal skin.
Measured: 6 months after repeated cesarean section
Secondary outcomes (1)
Patient Scar Assessment Scale (PSAS) score
The Patient Scar Assessment Scale (PSAS) consists of 6 items on scar-related pain, itchiness, color, stiffness, thickness, and irregularity. Each item uses a 10-point scoring system, summed to obtain a total score ranging from 6-60, with 6 representing normal skin with no associated symptoms.
Measured: 6 months after repeated cesarean section
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2020
- Study start15 May 2020
- Primary completion30 Jan 2021
- Study completion15 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cesarean SectionStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single-center, prospective, randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Università degli Studi dell'Insubria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonio Simone Laganà, Università degli Studi dell'Insubria
- Investigators
- Antonella Cromi, M.D., Ph.D., Principal investigator, Università degli Studi dell'InsubriaFabio Ghezzi, M.D., Study chair, Università degli Studi dell'InsubriaAntonio Simone Laganà, M.D., Ph.D., Study chair, Università degli Studi dell'Insubria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04302597
- Sponsor's protocol ID
- GLUE-1
- Status last verified
- Aug 2021
- First submitted
- 5 Mar 2020
- Last updated
- 8 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cromi A, Lagana AS, Ghezzi F, Valdatta L, Casarin J, Cherubino M. RETRACTED: Cosmetic outcomes of skin closure with tissue adhesive or staples in repeated cesarean section: A randomized controlled trial. Eur J Obstet Gynecol Reprod Biol. 2022 Apr;271:112-116. doi: 10.1016/j.ejogrb.2022.02.009. Epub 2022 Feb 14.
PubMed 35183000
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cosmetic Outcomes After Skin Closure of Pfannenstiel Incision With Tissue Adhesive (2-octylcyanoacrylate) or Staples in Repeated Cesarean Section
- ClinicalTrials.gov ID
- NCT04302597
- Acronym / sponsor ID
- GLUE-1
- Conditions
- Cesarean Section
- Keywords
- Cesarean delivery, Cosmesis, Healing, Skin closure, Scar assessment scales
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Università degli Studi dell'InsubriaUniversity, hospital or other
- Study start
- 15 May 2020 (actual)
- Primary completion
- 30 Jan 2021 (actual)
- Study completion
- 15 Jul 2021 (actual)
- First posted
- 10 Mar 2020 (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.
Recent clinical trials were developed to test the outcomes of skin closure with tissue adhesive, staples and monofilament synthetic suture after cesarean section with Pfannenstiel incision: both clinical outcomes such as blood loss, surgical site infection, length of postpartum hospitalization, or wound disruption, as well as Patient and Observer Scar Assessment Scale (POSAS) scores 8 weeks after surgery, were comparable between these different skin closure methods.
Despite the available studies are often based on robust methodologies and appropriate assessment scales, most of them were aimed to evaluate cosmetic outcomes in primary cesarean section, whereas data analyses published so far do not allow to draw a firm conclusion about repeated cesarean sections. Based on these elements, the aim of this study is to evaluate cosmetic outcomes after skin closure of Pfannenstiel incision with tissue adhesive or staples in a selected population undergoing repeated cesarean section.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Single-center, prospective, randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Staples | Active comparator | Procedure: StaplesWomen who underwent repeated cesarean section with skin closure using staples. |
| Tissue adhesive | Experimental | Procedure: Tissue adhesiveWomen who underwent repeated cesarean section with skin closure using 2-octylcyanoacrylate tissue adhesive. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Previous cesarean section with Pfannenstiel incision (regardless of the indication, emergency/urgency, weeks of pregnancy and years passed from the previous cesarean section)
- Maternal age 18-45 years
- Singleton pregnancy at 37-41 weeks of gestation (based on first-trimester ultrasound) with a viable fetus
Key exclusion criteria (6 listed)
- History of keloids
- Previous transversal suprapubic scars
- Clinical signs of infection and/or tattoos in the area to be studied
- Known patient hypersensitivity to any of the suture materials used in the protocol
- BMI below 20 or above 30
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 |
|---|---|---|
| StaplesSkin closure using surgical stapler. | Procedure or surgery | Staples |
| Tissue adhesiveSkin closure using 2-octylcyanoacrylate tissue adhesive. | Procedure or surgery | Tissue adhesive |
Primary outcome
Observer Scar Assessment Scale (OSAS) score
Time frame: 6 months after repeated cesarean section
The Observer Scar Assessment Scale (OSAS) rates 5 variables: vascularity, pigmentation, thickness, relief, and pliability. Each variable uses a 10-point scoring system, with 1 representing normal skin. Ratings of individual variables may be summed to obtain a total score ranging from 5-50, with 5 representing normal skin.
1 secondary outcome
Patient Scar Assessment Scale (PSAS) score
Time frame: 6 months after repeated cesarean section
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 8 Sep 2021.
- Derived from this study: PubMed 35183000Cromi A, Lagana AS, Ghezzi F, Valdatta L, Casarin J, Cherubino M. RETRACTED: Cosmetic outcomes of skin closure with tissue adhesive or staples in repeated cesarean section: A randomized controlled trial. Eur J Obstet Gynecol Reprod Biol. 2022 Apr;271:112-116. doi: 10.1016/j.ejogrb.2022.02.009. Epub 2022 Feb 14.
- Individual participant dataSharing planned: No
Related trials for Cesarean Section
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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.
Antonella Cromi, M.D., Ph.D. principal investigator
Università degli Studi dell'Insubria
Fabio Ghezzi, M.D. study chair
Università degli Studi dell'Insubria
Antonio Simone Laganà, M.D., Ph.D. study chair
Università degli Studi dell'Insubria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Staples and Tissue adhesive in people with Cesarean Section, run by Università degli Studi dell'Insubria at 1 site in Italy.
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 6 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 8 Sep 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 Italy. 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?
Observer Scar Assessment Scale (OSAS) score (time frame: 6 months after repeated cesarean section). 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 NCT04302597, which also lists 1 linked publication.
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 Sep 2021.