WoundNCT03052647
Comparison of Adhesive Latch Device to Subcuticular Skin Closure at the Time of Cesarean Section
A study testing Dermaclip and Subcuticular suture in people with Wound, run by Rubino Ob-Gyn Group at 1 site in United States.
Trial summary
The objective of this study was to compare the an adhesive latch device (" Dermaclip") to subcuticular skin closure at the time of cesarean section. Currently, no studies exist comparing these two closure techniques. The hypothesis is dermaclip closure is faster than subcuticular closure. 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
- Wound
- What is being tested?
- Dermaclip and Subcuticular suture
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2016to 1 Mar 2018
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age greater than 18
- Elective cesarean section
- Term pregnancy
Who cannot join
- Fever >101F in the past 14 days
- Antibiotics in the past 14 days
- Suspected ongoing infection
- Poorly controlled gestational diabetes
- Allergic to adhesive
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Rubino OBGYN Group
West Orange, New Jersey, 07052
Robert J Rubino, MD, 973-736-1100, rubinoobgyn@yahoo.com
Priya Patel, MD, 9737361100, ppatel@rubinoobgyn.com
About this study
The objective of this study was to compare the an adhesive latch device (" Dermaclip") to subcuticular skin closure at the time of cesarean section. Currently, no studies exist comparing these two closure techniques. The hypothesis is dermaclip closure is faster than subcuticular closure. The null hypothesis is there is no difference in closure times. There is a study (see reference at bottom) that compares staples closure to subcuticular closure, but none comparing subcuticular to dermaclip closure. Dermaclip device is easily deployed and is expected to be as fast as staples closure compared to subcuticular as noted in the prior study referenced below.
- Conditions
- Wound
- Being tested
- Dermaclip, Subcuticular suture
- Keywords
- dermaclip, subcuticular, cesarean section, staples, adhesive latch, rousseau
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DermaclipDevice
Also called adhesive latch device, dermaclip
Dermaclip is an adhesive latch device used for skin closure
Subcuticular sutureDevice
Also called sucuticular
subcuticular suture will be used as the device to close the skin in this arm
| Study group | Role | What they receive |
|---|---|---|
| Subcuticular arm | Active comparator | closure technique that the Adhesive Latch arem (dermaclip) arm is being compared to Receives: Device: Subcuticular suture |
| Adhesive Latch Arm (Demaclip arm) | Active comparator | This is the arm which the adhesive latch system is used and it is being compared to the arm of subcuticular Receives: Device: Dermaclip |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of adhesive latch device to subcuticular skin closure at the time of cesarean section
The time for skin closure between subcuticular and demaclip techniques will compared during cesarean section
Measured: 18 months
Secondary outcomes (9)
Pain Scores
- pain scores using the visual analog pain scale (VAPS) system
Measured: 18 months
Wound Infections as measured in centimeters of erythema
- wound infections will measured in centimeters of redness/erythema around the infected area
Measured: 18 months
Wound separation as measured in centimeters
- wound separation will be recorded centimeters
Measured: 18 months
Patient Satisfaction scores
- patient satisfaction
Measured: 18 months
Total surgery time
- total surgery time
Measured: 18 months
Age
- age (years)
Measured: 18 months
BMI
BMI of participants bmi (in kg/m2, weight in kg, height, in meters)
Measured: 18 months
Ethnicity
Ethnic origin
Measured: 18 months
Race
Race of participants
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2017
- Study start1 Jun 2016
- Primary completion30 Nov 2017 (estimated)
- Study completion1 Mar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A control group of subcuticular closure and the experimental group is skin closure withthe adhesive latch device ("dermaclip")
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rubino Ob-Gyn Group
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert J. Rubino, MD, FACOG, Rubino Ob-Gyn Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03052647
- Sponsor's protocol ID
- Rubinoobgyn
- Status last verified
- Feb 2017
- First submitted
- 3 Feb 2017
- Last updated
- 15 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Adhesive Latch Device to Subcuticular Skin Closure at the Time of Cesarean Section
- ClinicalTrials.gov ID
- NCT03052647
- Acronym / sponsor ID
- Rubinoobgyn
- Conditions
- Wound
- Keywords
- dermaclip, subcuticular, cesarean section, staples, adhesive latch, rousseau
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Rubino Ob-Gyn GroupUniversity, hospital or other
- Study start
- 1 Jun 2016 (actual)
- Primary completion
- 30 Nov 2017 (estimated)
- Study completion
- 1 Mar 2018 (estimated)
- First posted
- 14 Feb 2017 (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.
The objective of this study was to compare the an adhesive latch device (" Dermaclip") to subcuticular skin closure at the time of cesarean section. Currently, no studies exist comparing these two closure techniques. The hypothesis is dermaclip closure is faster than subcuticular closure. The null hypothesis is there is no difference in closure times. There is a study (see reference at bottom) that compares staples closure to subcuticular closure, but none comparing subcuticular to dermaclip closure. Dermaclip device is easily deployed and is expected to be as fast as staples closure compared to subcuticular as noted in the prior study referenced below.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- A control group of subcuticular closure and the experimental group is skin closure withthe adhesive latch device ("dermaclip")
| Arm | Type | Receives |
|---|---|---|
| Subcuticular arm | Active comparator | Device: Subcuticular sutureclosure technique that the Adhesive Latch arem (dermaclip) arm is being compared to |
| Adhesive Latch Arm (Demaclip arm) | Active comparator | Device: DermaclipThis is the arm which the adhesive latch system is used and it is being compared to the arm of subcuticular |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age greater than 18
- Elective cesarean section
- Term pregnancy
Key exclusion criteria (5 listed)
- Fever >101F in the past 14 days
- Antibiotics in the past 14 days
- Suspected ongoing infection
- Poorly controlled gestational diabetes
- Allergic to adhesive
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 |
|---|---|---|
| DermaclipAlso: adhesive latch device, dermaclipDermaclip is an adhesive latch device used for skin closure | Device | Adhesive Latch Arm (Demaclip arm) |
| Subcuticular sutureAlso: sucuticularsubcuticular suture will be used as the device to close the skin in this arm | Device | Subcuticular arm |
Primary outcome
Comparison of adhesive latch device to subcuticular skin closure at the time of cesarean section
Time frame: 18 months
The time for skin closure between subcuticular and demaclip techniques will compared during cesarean section
9 secondary outcomes
Pain Scores
Time frame: 18 months
Wound Infections as measured in centimeters of erythema
Time frame: 18 months
Wound separation as measured in centimeters
Time frame: 18 months
Patient Satisfaction scores
Time frame: 18 months
Total surgery time
Time frame: 18 months
Age
Time frame: 18 months
BMI
Time frame: 18 months
Ethnicity
Time frame: 18 months
Race
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2017.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dermaclip and Subcuticular suture in people with Wound, run by Rubino Ob-Gyn Group at 1 site in United States.
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 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 15 Feb 2017. 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 United States. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of adhesive latch device to subcuticular skin closure at the time of cesarean section (time frame: 18 months). 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 15 Feb 2017.