PregnancyNCT00505856
Dermabond Skin Adhesives vs Skin Staples for Closure of Repeat Cesarean Section Skin Incisions
An observational study of Pregnancy, run by Texas Tech University Health Sciences Center at 1 site in United States.
Trial summary
The use of dermabond skin adhesive vs. skin staples for the closure of repeat c-section incisions. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2007to Dec 2007
- Phase
- Observational
- 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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- pregant; between ages of 18-50; previous cesarean section with a transverse (sideways) skin incision.
Who cannot join
- Previous vertical (Up and Down) skin incision; active infection at site of incison
Trial locations and contacts
1 site in 1 country.
United States1 site
Texas Tech University HSC Dept OB/GYN
Lubbock, Texas, 79403
About this study
The use of dermabond skin adhesive vs. skin staples for the closure of repeat c-section incisions.
Read the detailed description
This research is interested in using Dermabond skin adhesive as a closure for repeat cesarean incisions. The current standard of practice is to close these incisions with either skin surgical staples or suture. We will compare the use of Dermabond vs. the use of skin surgical staples in the closure of these incisions.
Eightenn-50 year old pregnant patients are eligible for this study. Other inclusion criteria are history of a previous Pfannenstiel (transverse) incision and no evidence of infection at the incision site. Exclusion criteria include a previous vertical incision and active infection at the incision site. Patients will be enrolled during their prenatal appointments and the Texas Tech OB/GYN clinic, Grand Expectations, and the Southwest OB/GYN Associates offices. They will be consented by faculty, residents, and nursing staff. This is a preliminary study of 50 patients (25 in experimental arm, i.e. Dermabond and 25 in the control group, i.e. surgical skin staples). Patients will be randomized in a 1:1 fashion by placing the terms "Dermabond" and "Staples" in a sealed envelope. The envelopes will be kept in the Family Birth Center under lock and key. The envelopes will be opened at the time of repeat c-section. A data set will be collected prior to randomization and include: gravidity, parity, age, BMI (weight and height), comorbid diseases and ethnic background.
At the time of closure, there will be subcutaneous reapproximation of tissue to take the tension off of the skin. This will occur for all subjects. The type of suture used and the suturing technique will be recorded. The skin edges will be closed with either Dermabond per label directions or with skin staples, depending on randomization. The length of the incision, the type of suture used, the type of stitch used and the total number of layers closed will also be documented. The number of staples will also be documented.
During the hospital stay, the patients wound will be examined on post operative day one and three. At this time, wound characteristics will be documented using a modified Hollander scale. A digital photograph of the incision will also be taken. The patient will also be given a patient satisfaction survey about their wound. The patients will then be seen at two weeks post partum and again at six weeks post partum. The wound characteristics and patient satisfaction will again be documented using the above materials.
Other data that will be collected includes the incidence of wound infection, as documented by wound culture, wound separation rates as documented by need for wound packing and wound dehiscence.
- Conditions
- Pregnancy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2007 (estimated)
- Study startJul 2007
- Study completionDec 2007
Why it stopped: Resident project--resident left institution and was not picked up by anyone else
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Texas Tech University Health Sciences Center
- Sponsor type
- University, hospital or other
- Investigators
- Robert Casanova, MD, Principal investigator, Texas Tech University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00505856
- Sponsor's protocol ID
- L06-158
- Status last verified
- Dec 2008
- First submitted
- 23 Jul 2007
- Last updated
- 12 Dec 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dermabond Skin Adhesives vs Skin Staples for Closure of Repeat Cesarean Section Skin Incisions
- ClinicalTrials.gov ID
- NCT00505856
- Acronym / sponsor ID
- L06-158
- Conditions
- Pregnancy
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Resident project--resident left institution and was not picked up by anyone else
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Texas Tech University Health Sciences CenterUniversity, hospital or other
- Study start
- Jul 2007
- Study completion
- Dec 2007 (actual)
- First posted
- 25 Jul 2007 (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.
The use of dermabond skin adhesive vs. skin staples for the closure of repeat c-section incisions.
Detailed description
This research is interested in using Dermabond skin adhesive as a closure for repeat cesarean incisions. The current standard of practice is to close these incisions with either skin surgical staples or suture. We will compare the use of Dermabond vs. the use of skin surgical staples in the closure of these incisions.
Eightenn-50 year old pregnant patients are eligible for this study. Other inclusion criteria are history of a previous Pfannenstiel (transverse) incision and no evidence of infection at the incision site. Exclusion criteria include a previous vertical incision and active infection at the incision site. Patients will be enrolled during their prenatal appointments and the Texas Tech OB/GYN clinic, Grand Expectations, and the Southwest OB/GYN Associates offices. They will be consented by faculty, residents, and nursing staff. This is a preliminary study of 50 patients (25 in experimental arm, i.e. Dermabond and 25 in the control group, i.e. surgical skin staples). Patients will be randomized in a 1:1 fashion by placing the terms "Dermabond" and "Staples" in a sealed envelope. The envelopes will be kept in the Family Birth Center under lock and key. The envelopes will be opened at the time of repeat c-section. A data set will be collected prior to randomization and include: gravidity, parity, age, BMI (weight and height), comorbid diseases and ethnic background.
At the time of closure, there will be subcutaneous reapproximation of tissue to take the tension off of the skin. This will occur for all subjects. The type of suture used and the suturing technique will be recorded. The skin edges will be closed with either Dermabond per label directions or with skin staples, depending on randomization. The length of the incision, the type of suture used, the type of stitch used and the total number of layers closed will also be documented. The number of staples will also be documented.
During the hospital stay, the patients wound will be examined on post operative day one and three. At this time, wound characteristics will be documented using a modified Hollander scale. A digital photograph of the incision will also be taken. The patient will also be given a patient satisfaction survey about their wound. The patients will then be seen at two weeks post partum and again at six weeks post partum. The wound characteristics and patient satisfaction will again be documented using the above materials.
Other data that will be collected includes the incidence of wound infection, as documented by wound culture, wound separation rates as documented by need for wound packing and wound dehiscence.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- pregant; between ages of 18-50; previous cesarean section with a transverse (sideways) skin incision.
Key exclusion criteria (1 listed)
- Previous vertical (Up and Down) skin incision; active infection at site of incison
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: Resident project--resident left institution and was not picked up by anyone else). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2008.
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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.
Robert Casanova, MD principal investigator
Texas Tech University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy, run by Texas Tech University Health Sciences Center 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 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: stopped early, as of the sponsor's last update on 12 Dec 2008. 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?
The study was stopped early (reason given: Resident project--resident left institution and was not picked up by anyone else). 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.
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 12 Dec 2008.