Cesarean Section WoundPhase 4NCT01261715
Staples Versus Dermabond for Closure of the Skin After Cesarean Section
A Phase 4 study testing Dermabond- liquid skin adhesive in people with Cesarean Section Wound, run by Meir Medical Center at 1 site in Israel.
Trial summary
Two of the more frequently used options for skin closure following a cesarean delivery include staples or sutures (stitches). Another method of closure is Dermabond- liquid skin adhesive. This method of closure is used less frequently than either staples or sutures. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cesarean Section Wound
- What is being tested?
- Dermabond- liquid skin adhesive
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2011to Feb 2012
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Woman over 18 year Woman having elective caesarean section
Who cannot join
- Age under 18 Woman having an emergency caesarean section
Trial locations and contacts
1 site in 1 country.
About this study
Two of the more frequently used options for skin closure following a cesarean delivery include staples or sutures (stitches). Another method of closure is Dermabond- liquid skin adhesive. This method of closure is used less frequently than either staples or sutures.
Few studies have been done regarding whether Dermabond is preferable or affect the outcome of a cesarean section surgery. The aim of our study is to find weather Dermabond haas better result for the closure of cesarean section wounds.
- Conditions
- Cesarean Section Wound
- Being tested
- Dermabond- liquid skin adhesive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dermabond- liquid skin adhesiveProcedure or surgery
Dermabond- liquid skin adhesive
| Study group | Role | What they receive |
|---|---|---|
| Woman with previous ceasarean section - staples | Active comparator | Not described Receives: Procedure: Dermabond- liquid skin adhesive |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cosmetic objective evaluation of the scar
Measured: 6 weeks postoperatively
Secondary outcomes (2)
The difference in pain between the two type of closure
Measured: 1 and 4 days postoperatively
The difference in patient satisfaction with the scar result
Measured: 6 weeks postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2010 (estimated)
- Study startJan 2011
- Primary completionFeb 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean Section 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Dana Sadeh, MD, Principal investigator, MD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01261715
- Sponsor's protocol ID
- 155-2010
- Status last verified
- Oct 2010
- First submitted
- 6 Dec 2010
- Last updated
- 16 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Staples Versus Dermabond for Closure of the Skin After Cesarean Section
- ClinicalTrials.gov ID
- NCT01261715
- Acronym / sponsor ID
- 155-2010
- Conditions
- Cesarean Section Wound
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Feb 2012 (estimated)
- First posted
- 16 Dec 2010 (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.
Two of the more frequently used options for skin closure following a cesarean delivery include staples or sutures (stitches). Another method of closure is Dermabond- liquid skin adhesive. This method of closure is used less frequently than either staples or sutures.
Few studies have been done regarding whether Dermabond is preferable or affect the outcome of a cesarean section surgery. The aim of our study is to find weather Dermabond haas better result for the closure of cesarean section wounds.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Woman with previous ceasarean section - staples | Active comparator | Procedure: Dermabond- liquid skin adhesive |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Woman over 18 year Woman having elective caesarean section
Key exclusion criteria (1 listed)
- Age under 18 Woman having an emergency caesarean section
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 |
|---|---|---|
| Dermabond- liquid skin adhesiveDermabond- liquid skin adhesive | Procedure or surgery | Woman with previous ceasarean section - staples |
Primary outcome
Cosmetic objective evaluation of the scar
Time frame: 6 weeks postoperatively
2 secondary outcomes
The difference in pain between the two type of closure
Time frame: 1 and 4 days postoperatively
The difference in patient satisfaction with the scar result
Time frame: 6 weeks postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2010.
Related trials for Cesarean Section Wound
Not yet recruiting
The Mepilex Cesarean Delivery Trial / MEPIDEL
Surgical Site Infection
Not yet recruitingObservational study
Pain After Scheduled Cesarean Delivery: Spinal Morphine With or Without Levobupivacaine Wound Infiltration
Pain Management, C Section
Not yet recruitingObservational study
Timing of Cesarean Wound Dressing Removal on Wound Healing in Women With BMI ≥ 30 kg/m²
Cesarean Section, Surgical Wound Infection
Recruiting
Narrative Nursing for Cesarean Mothers' Anxiety and Breastfeeding Confidence
Postpartum Anxiety, Postpartum Depression (PPD)
Not yet recruitingPhase 2
The Use of Photobiomodulation for Pain and Healing in Cesarean Section
Post Partum, Cesarean Birth
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.
Dana Sadeh, MD principal investigator
MD
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 Dermabond- liquid skin adhesive in people with Cesarean Section Wound, 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 1 inclusion and 1 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 16 Dec 2010. 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?
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?
Cosmetic objective evaluation of the scar (time frame: 6 weeks postoperatively). 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 Dec 2010.