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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.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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

Other trials in United States

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.

  1. First posted25 Jul 2007 (estimated)
  2. Study startJul 2007
  3. Study completionDec 2007

Why it stopped: Resident project--resident left institution and was not picked up by anyone else

Resources

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)
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

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.

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