Cesarean SectionNCT00524511
Comparison Study of Wound Closure at Time of Cesarean Delivery: Dermabond Glue Versus Surgical Staples
A study testing Surgical skin staples and Dermabond in people with Cesarean Section, run by University of Massachusetts, Worcester at 1 site in United States.
Trial summary
Women who have a cesarean delivery have a surgical incision on their abdomen (belly). The usual way to close this opening is with metal surgical staples. In many other types of surgery, surgical incisions are closed with a super-glue called Dermabond. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Cesarean Section
- What is being tested?
- Surgical skin staples and Dermabond
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2007to May 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Pregnant women undergoing scheduled and non-scheduled cesarean deliveries
Who cannot join
- Prisoners
- Insulin-requiring diabetics
- Vertical skin incision
- Allergy to Dermabond
Trial locations and contacts
1 site in 1 country.
United States1 site
UMass Memorial Medical Center
Worcester, Massachusetts, 01604
About this study
Official title: A Comparative Study of Closure Techniques After Cesarean Section: Staples vs. Dermabond
Women who have a cesarean delivery have a surgical incision on their abdomen (belly). The usual way to close this opening is with metal surgical staples. In many other types of surgery, surgical incisions are closed with a super-glue called Dermabond. The researchers at the University of Massachusetts believe Dermabond may be a safe alternative to using staples at the time of a cesarean delivery, but this has not been studied. Women who choose to participate will be randomly assigned to have the cesarean delivery skin incision closed with staples or Dermabond. The researchers will survey the patients to see how they felt about the experience and the appearance of their scar. The researchers will survey physicians performing the surgery to see how easy Dermabond was to use. The researchers will ask physicians to evaluate the appearance of the incision after a 6-week recovery period and will analyze complications (such as bruising, infection, or separation of the wound) in the two groups.
- Conditions
- Cesarean Section
- Being tested
- Surgical skin staples, Dermabond
- Keywords
- cesarean, wound, Dermabond, superglue, staples, wound complications
- 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.
Surgical skin staplesDevice
Standard method to close abdominal surgical wounds
DermabondDevice
Also called Tissue adhesive
Alternative method (superglue) to close abdominal surgical wounds
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Women receiving Dermabond for skin closure Receives: Device: Surgical skin staples |
| 2 | Active comparator | Women receiving standard surgical skin staples Receives: Device: Dermabond |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound Complication Rate
Wound seroma or hematoma, wound separation, wound requiring packing, cellulitis, required extra medical clinic visits to evaluate wound
Measured: within six weeks of study intervention
Secondary outcomes (1)
Patient Satisfaction of Cosmesis of Surgical Wound
survey questionnaire using a visual analog scale to inquire about incision appearance, satisfaction with method of closure and comparison to previous closure type (if applicable)
Measured: before hospital discharge after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2007 (estimated)
- Study startSep 2007
- Primary completionMay 2012
- Study completionMay 2012
Why it stopped: Poor enrollment, much data was missing as patients were lost to follow up
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cesarean SectionStudies of the same condition, open and under way.
- More trials run by University of Massachusetts, WorcesterThe sponsor's other registered studies.
- 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
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dawn Tasillo, University of Massachusetts, Worcester
- Investigators
- Dawn S Tasillo, MD, Principal investigator, University of Massachusetts, Worcester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00524511
- Sponsor's protocol ID
- 12462
- Status last verified
- Jan 2013
- First submitted
- 31 Aug 2007
- Last updated
- 5 Mar 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study of Closure Techniques After Cesarean Section: Staples vs. Dermabond
- ClinicalTrials.gov ID
- NCT00524511
- Acronym / sponsor ID
- 12462
- Conditions
- Cesarean Section
- Keywords
- cesarean, wound, Dermabond, superglue, staples, wound complications
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor enrollment, much data was missing as patients were lost to follow up
- Enrolment
- 136 participants (actual)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 3 Sep 2007 (estimated)
- Results
- Posted 5 Mar 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Women who have a cesarean delivery have a surgical incision on their abdomen (belly). The usual way to close this opening is with metal surgical staples. In many other types of surgery, surgical incisions are closed with a super-glue called Dermabond. The researchers at the University of Massachusetts believe Dermabond may be a safe alternative to using staples at the time of a cesarean delivery, but this has not been studied. Women who choose to participate will be randomly assigned to have the cesarean delivery skin incision closed with staples or Dermabond. The researchers will survey the patients to see how they felt about the experience and the appearance of their scar. The researchers will survey physicians performing the surgery to see how easy Dermabond was to use. The researchers will ask physicians to evaluate the appearance of the incision after a 6-week recovery period and will analyze complications (such as bruising, infection, or separation of the wound) in the two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: Surgical skin staplesWomen receiving Dermabond for skin closure |
| 2 | Active comparator | Device: DermabondWomen receiving standard surgical skin staples |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Pregnant women undergoing scheduled and non-scheduled cesarean deliveries
Key exclusion criteria (4 listed)
- Prisoners
- Insulin-requiring diabetics
- Vertical skin incision
- Allergy to Dermabond
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 |
|---|---|---|
| Surgical skin staplesStandard method to close abdominal surgical wounds | Device | 1 |
| DermabondAlso: Tissue adhesiveAlternative method (superglue) to close abdominal surgical wounds | Device | 2 |
Primary outcome
Wound Complication Rate
Time frame: within six weeks of study intervention
Wound seroma or hematoma, wound separation, wound requiring packing, cellulitis, required extra medical clinic visits to evaluate wound
1 secondary outcome
Patient Satisfaction of Cosmesis of Surgical Wound
Time frame: before hospital discharge after surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Esketamine Combined With Transcutaneous Electrical Acupoint Stimulation on Postoperative Recovery Quality After Elective Cesarean Section
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Early Heart Rate Variability and Sleep and Quality of Recovery After Cesarean Delivery
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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.
Dawn S Tasillo, MD principal investigator
University of Massachusetts, Worcester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgical skin staples and Dermabond in people with Cesarean Section, run by University of Massachusetts, Worcester 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 1 inclusion and 4 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: stopped early, as of the sponsor's last update on 5 Mar 2013. 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?
Yes. Results are posted in the registry (first posted 5 Mar 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Wound Complication Rate (time frame: within six weeks of study intervention). 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 5 Mar 2013; AzTrials last refreshed its copy on 7 Nov 2026.