ScarNCT04621994
Cesarean Wound Closure: Dermabond Versus Steri Strips
A study testing Dermabond and Steri Strips in people with Scar, run by University of Tennessee.
Trial summary
The purpose of this study is to determine overall patient satisfaction with their cesarean section scar with application of Steri-strips vs. Dermabond following subcuticular skin closure of pfannenstiel incision 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
- Scar
- What is being tested?
- Dermabond and Steri Strips
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 133 participants
- Where
- No sites listed yet
- Study dates
- Nov 2020to Jul 2022
- 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
- Women age 18-45 who are undergoing planned or unscheduled cesarean section at Regional One Health
- Gestational age > 24 weeks
- Planned Pfannenstiel incision
- Willing to consent to the study
Who cannot join
- Emergency or urgent cesarean section
- Vertical skin incision
- Intrapartum intraamniotic infection
- Diabetes
- Unwilling to consent to the study
About this study
The purpose of this study is to determine overall patient satisfaction with their cesarean section scar with application of Steri-strips vs. Dermabond following subcuticular skin closure of pfannenstiel incision
- Conditions
- Scar
- Being tested
- Dermabond, Steri Strips
- Medical subject headings
- Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DermabondOther
Dermabond will be applied after subcuticular skin closure in lieu of Steri Strips
Steri StripsOther
Steri Strips will be applied after subcuticular skin closure as routinely done at our institution
| Study group | Role | What they receive |
|---|---|---|
| Steri Strips Arm | Active comparator | Not described Receives: Other: Steri Strips |
| Dermabond Arm | Experimental | Not described Receives: Other: Dermabond |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient and Observer Scar Assessment Scale Surveys (POSAS)
Validated scale comparing a scar to normal skin. Score ranges from 6 to 60 with the higher numbers less like normal skin.
Measured: at 1 weeks postpartum
Patient and Observer Scar Assessment Scale Surveys
Validated scale comparing a scar to normal skin. Score ranges from 6 to 60 with the higher numbers less like normal skin.
Measured: at 6 weeks postpartum
Secondary outcomes (2)
Number of patients with wound infection
Measured: through 6 weeks postpartum
Number of patients with wound separation or dehiscence
Measured: through 6 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2020
- Study startNov 2020 (estimated)
- Primary completionApr 2021 (estimated)
- Study completionJul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ScarStudies 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
- Masking
- None (open label)
- Enrolment
- 133 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Tennessee
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laura Grese Willingham, University of Tennessee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04621994
- Sponsor's protocol ID
- 20-07302-FB
- Status last verified
- Nov 2020
- First submitted
- 30 Oct 2020
- Last updated
- 9 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cesarean Wound Closure: Dermabond Versus Steri Strips
- ClinicalTrials.gov ID
- NCT04621994
- Acronym / sponsor ID
- 20-07302-FB
- Conditions
- Scar
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 133 participants (estimated)
- Lead sponsor
- University of TennesseeUniversity, hospital or other
- Study start
- Nov 2020 (estimated)
- Primary completion
- Apr 2021 (estimated)
- Study completion
- Jul 2022 (estimated)
- First posted
- 9 Nov 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.
The purpose of this study is to determine overall patient satisfaction with their cesarean section scar with application of Steri-strips vs. Dermabond following subcuticular skin closure of pfannenstiel incision
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Steri Strips Arm | Active comparator | Other: Steri Strips |
| Dermabond Arm | Experimental | Other: Dermabond |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Women age 18-45 who are undergoing planned or unscheduled cesarean section at Regional One Health
- Gestational age > 24 weeks
- Planned Pfannenstiel incision
- Willing to consent to the study
Key exclusion criteria (5 listed)
- Emergency or urgent cesarean section
- Vertical skin incision
- Intrapartum intraamniotic infection
- Diabetes
- Unwilling to consent to the study
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 |
|---|---|---|
| DermabondDermabond will be applied after subcuticular skin closure in lieu of Steri Strips | Other | Dermabond Arm |
| Steri StripsSteri Strips will be applied after subcuticular skin closure as routinely done at our institution | Other | Steri Strips Arm |
Primary outcome
Patient and Observer Scar Assessment Scale Surveys (POSAS)
Time frame: at 1 weeks postpartum
Validated scale comparing a scar to normal skin. Score ranges from 6 to 60 with the higher numbers less like normal skin.
Patient and Observer Scar Assessment Scale Surveys
Time frame: at 6 weeks postpartum
Validated scale comparing a scar to normal skin. Score ranges from 6 to 60 with the higher numbers less like normal skin.
2 secondary outcomes
Number of patients with wound infection
Time frame: through 6 weeks postpartum
Number of patients with wound separation or dehiscence
Time frame: through 6 weeks postpartum
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2020.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Dermabond and Steri Strips in people with Scar, run by University of Tennessee.
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 4 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 9 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Patient and Observer Scar Assessment Scale Surveys (POSAS) (time frame: at 1 weeks postpartum). The study lists 2 primary outcomes in all. 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 9 Nov 2020.