Wound DisruptionNCT01867567
Early Bandage Removal Post-Cesarean Delivery
A study testing abdominal bandage in people with Wound Disruption and Wound Infection, run by Ziv Hospital at 1 site in Israel.
Trial summary
Women undergoing their first second or third cesarean section will be randomized into two groups. One group will have the abdominal bandage removed at 6 hours post-surgery and the other group will have the bandage removed at 24 hours. Staple removal will be at 5 - 7 days for both groups. Read more about this study
- Who is it for?
- Ages 18 to 44 years, women only
- Conditions the study is for
- Wound Disruption, Wound Infection
- What is being tested?
- abdominal bandage
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 1 siteIsrael
- Study dates
- Aug 2013to Apr 2015
- 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 44 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- age of 18 to 44
- elective cesarean section, primary or repeat
- low risk pregnancy
Who cannot join
- under the age of 18 and above the age of 44
- diabetes, preeclampsia or other pregnancy complications
- unable or unwilling to give informed consent
- chorioamnionitis
- BMI over 35
- more than 3 cesareans
Trial locations and contacts
1 site in 1 country.
About this study
Women undergoing their first second or third cesarean section will be randomized into two groups. One group will have the abdominal bandage removed at 6 hours post-surgery and the other group will have the bandage removed at 24 hours. Staple removal will be at 5 - 7 days for both groups. The incision will be inspected at the time of staple removal. The 2 groups will be compared for incision disruption and infection. Also, the women will be asked about their satisfaction for time of bandage removal.
- Conditions
- Wound Disruption, Wound Infection
- Being tested
- abdominal bandage
- Keywords
- cesarean, bandage removal, infection, disruption, satisfaction, patient satisfaction
- Medical subject headings
- Wound Infection, Infections, Personal Satisfaction, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
abdominal bandageProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| 6 Hours | Experimental | Removal of bandage after 6 hours Receives: Procedure: abdominal bandage |
| 24 hours | Active comparator | removal of bandage after 24 hours Receives: Procedure: abdominal bandage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound Disruption
Measured: 5 - 7 days
Secondary outcomes (2)
Wound Infection
Measured: 5 - 7 days
Patient satisfaction
Measured: 5 - 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2013 (estimated)
- Study startAug 2013
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound DisruptionStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 320 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ziv Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, David Peleg, Ziv Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01867567
- Sponsor's protocol ID
- CSBandage
- Status last verified
- Dec 2015
- First submitted
- 26 May 2013
- Last updated
- 30 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Bandage Removal Post-Cesarean Delivery
- ClinicalTrials.gov ID
- NCT01867567
- Acronym / sponsor ID
- CSBandage
- Conditions
- Wound Disruption, Wound Infection
- Keywords
- cesarean, bandage removal, infection, disruption, satisfaction, patient satisfaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 320 participants (actual)
- Lead sponsor
- Ziv HospitalOther government
- Study start
- Aug 2013
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 4 Jun 2013 (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.
Women undergoing their first second or third cesarean section will be randomized into two groups. One group will have the abdominal bandage removed at 6 hours post-surgery and the other group will have the bandage removed at 24 hours. Staple removal will be at 5 - 7 days for both groups. The incision will be inspected at the time of staple removal. The 2 groups will be compared for incision disruption and infection. Also, the women will be asked about their satisfaction for time of bandage removal.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 6 Hours | Experimental | Procedure: abdominal bandageRemoval of bandage after 6 hours |
| 24 hours | Active comparator | Procedure: abdominal bandageremoval of bandage after 24 hours |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- age of 18 to 44
- elective cesarean section, primary or repeat
- low risk pregnancy
Key exclusion criteria (6 listed)
- under the age of 18 and above the age of 44
- diabetes, preeclampsia or other pregnancy complications
- unable or unwilling to give informed consent
- chorioamnionitis
- BMI over 35
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 |
|---|---|---|
| abdominal bandage | Procedure or surgery | 24 hours, 6 Hours |
Primary outcome
Wound Disruption
Time frame: 5 - 7 days
2 secondary outcomes
Wound Infection
Time frame: 5 - 7 days
Patient satisfaction
Time frame: 5 - 7 days
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 30 Dec 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing abdominal bandage in people with Wound Disruption and Wound Infection, run by Ziv Hospital 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 3 inclusion and 6 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 30 Dec 2015. 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.
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?
Wound Disruption (time frame: 5 - 7 days). 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 30 Dec 2015.