Adhesive; BandPhase 4SVGCSNCT02831946
Suture Versus Glue (Dermabond) Closure During Cesarean Delivery
A Phase 4 study testing MODIFIED VICRYL PLUS and DERMABOND GLUE in people with Adhesive; Band and Suture; Complications, run by Meir Medical Center at 1 site in Israel.
Trial summary
To investigate the effect of intracutaneous suture closure versus Glue (dermabond) closure at cesarean section (CS) on long-term cosmetic and maternal outcome. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Adhesive; Band, Suture; Complications
- What is being tested?
- MODIFIED VICRYL PLUS and DERMABOND GLUE
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- May 2016to Feb 2018
- Phase
- Phase 4
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Pregnant women between 18 and 45 years
- Elective cesarian section
Who cannot join
- Clinical signs of infection at the time of CS
- History of keloids and a medical disorder that could affect wound healing
- Hypersensitivity to any of the suture materials used in the protocol
- Diabetes mellitus
- Disorders requiring chronic corticosteroid use or immunosuppression
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Meir Medical Center
Kfar Saba, Israel, 11125
Yair M Daykan, MD, 972-54-2198231, yair.dykan@gmail.com
About this study
Official title: Intracuticular Sutures Versus Glue (Dermabond) for Skin Closure After Cesarean Delivery
To investigate the effect of intracutaneous suture closure versus Glue (dermabond) closure at cesarean section (CS) on long-term cosmetic and maternal outcome.
Read the detailed description
Women undergoing planned CS were randomized to either intracutaneous suture closure or glue closure using a 1:1 allocation algorithm. Participants and outcome assessors were blinded to group allocation. Scar evaluation was performed after two months.
Primary outcome measures were Patient and Observer Scar Assessment Scale (POSAS) summary scores 2 months after surgery. Secondary outcome measures were, duration of surgery, and development of hematoma, seroma, surgical site infection (SSI) or wound disruption.
Data were analyzed according to the intention to treat principle.
- Conditions
- Adhesive; Band, Suture; Complications
- Being tested
- MODIFIED VICRYL PLUS, DERMABOND GLUE
- Keywords
- skin closure, intracuticular suture, glue (dermabond)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MODIFIED VICRYL PLUSDevice
closing the intra-cuticular layer with MODIFIED VICRYL PLUS suture
DERMABOND GLUEDevice
closing the intra-cuticular layer with Dermabond glue
| Study group | Role | What they receive |
|---|---|---|
| MODIFIED VICRYL PLUS | Experimental | The intra-cuticular layer will closed with with VICRYL PLUS suture Receives: Device: MODIFIED VICRYL PLUS |
| DERMABOND GLUE | Experimental | The intra-cuticular layer will closed with with DERMABOND GLUE Receives: Device: DERMABOND GLUE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient and Observer Scar Assessment Scale (POSAS)
Subjective scar rating will be performed using the patient component of the POSAS. The POSAS Scale consists of 2 numerical numeric scales: The Patient Scar Assessment Scale and the Observer Scar Assessment Scale
Measured: 2 month
Secondary outcomes (1)
post operative complication
Development of surgical site infection or wound disruption.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2016 (estimated)
- Study startMay 2016
- Primary completionMay 2017 (estimated)
- Study completionFeb 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adhesive; BandStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yair Daykan, Meir Medical Center
- Investigators
- Reut Ohana, Principal investigator, Meir Helsinki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02831946
- Sponsor's protocol ID
- 0062-16-MMC
- Acronym
- SVGCS
- Status last verified
- Jul 2016
- First submitted
- 14 Jun 2016
- Last updated
- 13 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: within 6 m of finishing the study
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intracuticular Sutures Versus Glue (Dermabond) for Skin Closure After Cesarean Delivery
- ClinicalTrials.gov ID
- NCT02831946
- Acronym / sponsor ID
- SVGCS / 0062-16-MMC
- Conditions
- Adhesive; Band, Suture; Complications
- Keywords
- skin closure, intracuticular suture, glue (dermabond)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- May 2017 (estimated)
- Study completion
- Feb 2018 (estimated)
- First posted
- 13 Jul 2016 (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.
To investigate the effect of intracutaneous suture closure versus Glue (dermabond) closure at cesarean section (CS) on long-term cosmetic and maternal outcome.
Detailed description
Women undergoing planned CS were randomized to either intracutaneous suture closure or glue closure using a 1:1 allocation algorithm. Participants and outcome assessors were blinded to group allocation. Scar evaluation was performed after two months.
Primary outcome measures were Patient and Observer Scar Assessment Scale (POSAS) summary scores 2 months after surgery. Secondary outcome measures were, duration of surgery, and development of hematoma, seroma, surgical site infection (SSI) or wound disruption.
Data were analyzed according to the intention to treat principle.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MODIFIED VICRYL PLUS | Experimental | Device: MODIFIED VICRYL PLUSThe intra-cuticular layer will closed with with VICRYL PLUS suture |
| DERMABOND GLUE | Experimental | Device: DERMABOND GLUEThe intra-cuticular layer will closed with with DERMABOND GLUE |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Pregnant women between 18 and 45 years
- Elective cesarian section
Key exclusion criteria (5 listed)
- Clinical signs of infection at the time of CS
- History of keloids and a medical disorder that could affect wound healing
- Hypersensitivity to any of the suture materials used in the protocol
- Diabetes mellitus
- Disorders requiring chronic corticosteroid use or immunosuppression
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 |
|---|---|---|
| MODIFIED VICRYL PLUSclosing the intra-cuticular layer with MODIFIED VICRYL PLUS suture | Device | MODIFIED VICRYL PLUS |
| DERMABOND GLUEclosing the intra-cuticular layer with Dermabond glue | Device | DERMABOND GLUE |
Primary outcome
Patient and Observer Scar Assessment Scale (POSAS)
Time frame: 2 month
Subjective scar rating will be performed using the patient component of the POSAS. The POSAS Scale consists of 2 numerical numeric scales: The Patient Scar Assessment Scale and the Observer Scar Assessment Scale
1 secondary outcome
post operative complication
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2016.
- Individual participant dataSharing planned: Yes. within 6 m of finishing the study
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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.
Reut Ohana principal investigator
Meir Helsinki
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing MODIFIED VICRYL PLUS and DERMABOND GLUE in people with Adhesive; Band and Suture; Complications, run by Meir Medical Center at 1 site in Israel.
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 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 13 Jul 2016. 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 Israel. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Yair M Daykan, MD (972-542198231, yair.dykan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient and Observer Scar Assessment Scale (POSAS) (time frame: 2 month). 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 13 Jul 2016.