Caesarean DeliveryNCT01542346
Subcutaneous Adaption and Cosmetic Outcome Following Caesarean Delivery
A study testing subcutaneous adaption in people with Caesarean Delivery, run by Klinikum Klagenfurt am Wörthersee at 1 site in Austria.
Trial summary
This is a double blinded randomized study investigating if subcutaneous adaption has an impact on cosmetic outcome after Caesarean delivery. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Caesarean Delivery
- What is being tested?
- subcutaneous adaption
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteAustria
- Study dates
- Mar 2012to not given
- Phase
- Interventional
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- women undergoing cesarean section for any indication
- literate in german language
Who cannot join
- history of keloids
- previous transversal suprapubic scars
- known patient hypersensitivity to any of the suture materials used in the protocol
- a medical disorder that could affect wound healing (eg, diabetes mellitus, chronic corticosteroid use)
Trial locations and contacts
1 site in 1 country.
About this study
This is a double blinded randomized study investigating if subcutaneous adaption has an impact on cosmetic outcome after Caesarean delivery.
- Conditions
- Caesarean Delivery
- Being tested
- subcutaneous adaption
- Keywords
- Wound closure, cosmetic outcome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
subcutaneous adaptionProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| wound closure with subcutaneous adaption | Experimental | Not described Receives: Procedure: subcutaneous adaption |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective and subjective cosmetic appearance
Measured: after 6 months
Secondary outcomes (2)
Surgical site infection and wound breakdown
Measured: within 30 days after surgery
Haematoma
Measured: within 5 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2012 (estimated)
- Study startMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Caesarean DeliveryStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Klinikum Klagenfurt am Wörthersee
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Husslein Heinrich, MD, Klinikum Klagenfurt am Wörthersee
- Investigators
- Heinrich Husslein, M.D., Principal investigator, Klinikum Klagenfurt am Woerthersee and Medical University Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01542346
- Sponsor's protocol ID
- A 16/11
- Status last verified
- Jul 2013
- First submitted
- 25 Feb 2012
- Last updated
- 15 Jul 2013
- Results posted
- No
Publications
Husslein H, Gutschi M, Leipold H, Herbst C, Franz M, Worda C. Suture Closure versus Non-Closure of Subcutaneous Fat and Cosmetic Outcome after Cesarean Section: A Randomized Controlled Trial. PLoS One. 2014 Dec 10;9(12):e114730. doi: 10.1371/journal.pone.0114730. eCollection 2014.
PubMed 25494177
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subcutaneous Adaption and Cosmetic Outcome Following Caesarean Delivery
- ClinicalTrials.gov ID
- NCT01542346
- Acronym / sponsor ID
- A 16/11
- Conditions
- Caesarean Delivery
- Keywords
- Wound closure, cosmetic outcome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- Klinikum Klagenfurt am WörtherseeUniversity, hospital or other
- Study start
- Mar 2012
- First posted
- 2 Mar 2012 (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 double blinded randomized study investigating if subcutaneous adaption has an impact on cosmetic outcome after Caesarean delivery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| wound closure with subcutaneous adaption | Experimental | Procedure: subcutaneous adaption |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- women undergoing cesarean section for any indication
- literate in german language
Key exclusion criteria (4 listed)
- history of keloids
- previous transversal suprapubic scars
- known patient hypersensitivity to any of the suture materials used in the protocol
- a medical disorder that could affect wound healing (eg, diabetes mellitus, chronic corticosteroid use)
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 |
|---|---|---|
| subcutaneous adaption | Procedure or surgery | wound closure with subcutaneous adaption |
Primary outcome
Objective and subjective cosmetic appearance
Time frame: after 6 months
2 secondary outcomes
Surgical site infection and wound breakdown
Time frame: within 30 days after surgery
Haematoma
Time frame: within 5 days after surgery
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 15 Jul 2013.
- Derived from this study: PubMed 25494177Husslein H, Gutschi M, Leipold H, Herbst C, Franz M, Worda C. Suture Closure versus Non-Closure of Subcutaneous Fat and Cosmetic Outcome after Cesarean Section: A Randomized Controlled Trial. PLoS One. 2014 Dec 10;9(12):e114730. doi: 10.1371/journal.pone.0114730. eCollection 2014.
Related trials for Caesarean Delivery
Not yet recruiting
Comparison of Effect of Two Different Doses of Intravenous Oxytocin on Patients Undergoing Elective Cesarean Section
Postpartum Hemorrhage, Uterine Atony
Not yet recruitingObservational study
Ultrasound Assessment Of Gastric Volume In Pregnant Women Undergoing Elective Cesarean Section
Gestational Diabetes Mellitus (GDM), Obstetric Anesthesia
Active, not recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section
Active, not recruiting
Implementation of a Disparities in Labor Outcomes Dashboard
Labor Induction, Cesarean Birth
RecruitingPhase 1
Ketamine Pharmacokinetics and Pharmacodynamics for Postpartum Depression and Pain After Cesarean Delivery
Pain, Postpartum Depression
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.
Heinrich Husslein, M.D. principal investigator
Klinikum Klagenfurt am Woerthersee and Medical University Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing subcutaneous adaption in people with Caesarean Delivery, run by Klinikum Klagenfurt am Wörthersee at 1 site in Austria.
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 2 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: finished, as of the sponsor's last update on 15 Jul 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 Austria. 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 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?
Objective and subjective cosmetic appearance (time frame: after 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01542346, which also lists 1 linked publication.
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 15 Jul 2013.