EpisiotomyPhase 3NCT00196508
A Study Comparing Topical Skin Adhesive or Sutures for Closure Due to Episiotomy or Perineal Tears Following Childbirth
A Phase 3 study testing High Viscosity DERMABOND in people with Episiotomy and Perineal Tear, run by Ethicon, Inc. at 5 sites in United States.
Trial summary
This is a randomized controlled trial and multi-centered study with a 2-arm design. The treatment group will receive topical skin adhesive for skin closure of their wound and the control will receive sutures. Subjects will be assessed at follow-up visits. Patients are required to maintain a diary postpartum. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Episiotomy, Perineal Tear
- What is being tested?
- High Viscosity DERMABOND
- Type of treatment
- Medical device
- How many people
- 118 participants
- Where
- 5 sitesUnited States
- Study dates
- Apr 2005to Jan 2006
- Phase
- Phase 3
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is at least 18 years of age.
- Patient has an episiotomy incision or perineal tear resulting from a vaginal delivery.
- Patient agrees to participate in the follow-up schedule of assessments and completion of a daily diary.
- Patient has signed the informed consent form.
Who cannot join
- Patient has peripheral vascular disease.
- Patient has insulin dependent diabetes mellitus.
- Patient has a blood clotting disorder that requires therapy.
- Patient has a personal or family history of keloid formation or hypertrophy.
- Patient has a known allergy to cyanoacrylates or formaldehyde.
- Patient has impaired wound healing by history. Patient is a chronic steroid user.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Study site
Bessemer, Alabama, 35021
McDonald Murrmann Women's Clinic
Memphis, Tennessee, 38120
Phoenix OB-GYN Associates
Moorestown, New Jersey, 08057
Tidewater Physicians for Women
Norfolk, Virginia, 23502
Virginia Beach Obstetrics & Gynecology
Virginia Beach, Virginia, 23454
About this study
Official title: A Randomized, Multi Center Study to Evaluate the Clinical Performance of Topical Skin Adhesive in Comparison to Sutures for Perineal Skin Closure Following Childbirth
This is a randomized controlled trial and multi-centered study with a 2-arm design. The treatment group will receive topical skin adhesive for skin closure of their wound and the control will receive sutures. Subjects will be assessed at follow-up visits. Patients are required to maintain a diary postpartum.
- Conditions
- Episiotomy, Perineal Tear
- Being tested
- High Viscosity DERMABOND
- Keywords
- Childbirth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Viscosity DERMABONDDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Topical skin adhesive is non-inferior to sutures when used for skin closure following an episiotomy incision or perineal tear resulting from childbirth
The incidence of perineal skin opening requiring re-closure post-partum
Secondary outcomes (4)
Presence and extent of clinically relevant skin openings
Presence and extent of acute inflammatory reaction, pain, itch and discomfort associated with the perineal skin area
Perineal skin closure cosmesis
Patient satisfaction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startApr 2005
- Study completionJan 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpisiotomyStudies 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 3
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 118 participants
Sponsor and investigators
- Lead sponsor
- Ethicon, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00196508
- Sponsor's protocol ID
- 200-04-001
- Status last verified
- Jun 2006
- First submitted
- 13 Sep 2005
- Last updated
- 16 Oct 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Multi Center Study to Evaluate the Clinical Performance of Topical Skin Adhesive in Comparison to Sutures for Perineal Skin Closure Following Childbirth
- ClinicalTrials.gov ID
- NCT00196508
- Acronym / sponsor ID
- 200-04-001
- Conditions
- Episiotomy, Perineal Tear
- Keywords
- Childbirth
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants
- Lead sponsor
- Ethicon, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2005
- Study completion
- Jan 2006
- First posted
- 20 Sep 2005 (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.
This is a randomized controlled trial and multi-centered study with a 2-arm design. The treatment group will receive topical skin adhesive for skin closure of their wound and the control will receive sutures. Subjects will be assessed at follow-up visits. Patients are required to maintain a diary postpartum.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient is at least 18 years of age.
- Patient has an episiotomy incision or perineal tear resulting from a vaginal delivery.
- Patient agrees to participate in the follow-up schedule of assessments and completion of a daily diary.
- Patient has signed the informed consent form.
Key exclusion criteria (6 listed)
- Patient has peripheral vascular disease.
- Patient has insulin dependent diabetes mellitus.
- Patient has a blood clotting disorder that requires therapy.
- Patient has a personal or family history of keloid formation or hypertrophy.
- Patient has a known allergy to cyanoacrylates or formaldehyde.
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 |
|---|---|---|
| High Viscosity DERMABOND | Device | – |
Primary outcome
Topical skin adhesive is non-inferior to sutures when used for skin closure following an episiotomy incision or perineal tear resulting from childbirth
The incidence of perineal skin opening requiring re-closure post-partum
4 secondary outcomes
Presence and extent of clinically relevant skin openings
Presence and extent of acute inflammatory reaction, pain, itch and discomfort associated with the perineal skin area
Perineal skin closure cosmesis
Patient satisfaction
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 16 Oct 2007.
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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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing High Viscosity DERMABOND in people with Episiotomy and Perineal Tear, run by Ethicon, Inc. at 5 sites 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 4 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 16 Oct 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Topical skin adhesive is non-inferior to sutures when used for skin closure following an episiotomy incision or perineal tear resulting from childbirth. 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 16 Oct 2007.