Cesarean Section; Wound, Infection (Following Delivery)ROCDNCT03063853
Removal of Surgical Staples After Cesarean Delivery. Randomized Control Trial.
A study testing Removal of surgical clips at day 4 post operative vs day 8 post operative and Elective cesarean delivery in people with Cesarean Section; Wound, Infection (Following Delivery), run by Wolfson Medical Center at 1 site in Israel.
Trial summary
The optimal choice of skin closure at cesarean delivery has not yet been determined. This study aim to study the wound complications and scar healing after Surgical staples removal at postoperative day 4 and day 8 . A randomized control trial. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cesarean Section; Wound, Infection (Following Delivery)
- What is being tested?
- Removal of surgical clips at day 4 post operative vs day 8 post operative and Elective cesarean delivery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Feb 2017to 30 Oct 2017
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- elective cesarean delivery
- previous cesarean delivery performed using the Pfannenstiel method
- 36-41 weeks of gestation based on first trimester ultrasound and a viable fetus.
Who cannot join
- emergency cesarean delivery
- clinical signs of infection at the time of CD, uncontrolled
- vunblanaced diabetes mellitus
- history of keloids
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Early Versus Late Removal of Surgical Staples After Cesarean Delivery. Randomized Control Trial.
The optimal choice of skin closure at cesarean delivery has not yet been determined. This study aim to study the wound complications and scar healing after Surgical staples removal at postoperative day 4 and day 8 .
A randomized control trial.
Read the detailed description
A randomized controlled trial in which pregnant women undergoing a scheduled Elective cesarean delivery were assigned to skin closure with surgical staples and were randomly assigned to the day of removal of surgical staples. Postoperative day 4 VS. Postoperative day 8 .
Outcome assessors were blinded to group allocation. Scars will be evaluated after 8 weeks. Primary outcome measures is Patient and Observer Scar Assessment Scale (POSAS) scores. Secondary outcome measures are complications of surgical site infection (SSI) or wound disruption (hematoma or seroma).
A group of 104 women is needed in order to achieve a clinically significant effect with a power of 80%.
- Being tested
- Removal of surgical clips at day 4 post operative vs day 8 post operative, Elective cesarean delivery
- Medical subject headings
- Wounds and Injuries, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Removal of surgical clips at day 4 post operative vs day 8 post operativeOther
Removal of surgical clips at day 4 post operative vs day 8 post operative
Elective cesarean deliveryProcedure or surgery
non emergent elective cesarean delivery
| Study group | Role | What they receive |
|---|---|---|
| POD4 | Other | REMOVAL OF SURGICAL STAPLES AT POSTOPERATIVE DAY 4 Receives: Other: Removal of surgical clips at day 4 post operative vs day 8 post operative; Procedure: Elective cesarean delivery |
| POD8 | Other | REMOVAL OF SURGICAL STAPLES AT POSTOPERATIVE DAY 8 Receives: Other: Removal of surgical clips at day 4 post operative vs day 8 post operative; Procedure: Elective cesarean delivery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient and Observer Scar Assessment Scale (POSAS) scores.
Measured: 8 weeks postoperative
Secondary outcomes (1)
complications of surgical site infection (SSI) or wound disruption (hematoma or seroma).
Measured: 8 weeks postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2017
- Study start1 Feb 2017
- Primary completion30 Oct 2017
- Study completion30 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean Section; Wound, Infection (Following Delivery)Studies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wolfson Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Hadas Miremberg, MD, Principal investigator, Wolfson Medical Center- Tel Aviv University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03063853
- Sponsor's protocol ID
- 0150-16- WOMC
- Acronym
- ROCD
- Status last verified
- Feb 2017
- First submitted
- 22 Feb 2017
- Last updated
- 8 May 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Versus Late Removal of Surgical Staples After Cesarean Delivery. Randomized Control Trial.
- ClinicalTrials.gov ID
- NCT03063853
- Acronym / sponsor ID
- ROCD / 0150-16- WOMC
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Wolfson Medical CenterOther government
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 30 Oct 2017 (actual)
- Study completion
- 30 Oct 2017 (actual)
- First posted
- 24 Feb 2017 (actual)
- 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 optimal choice of skin closure at cesarean delivery has not yet been determined. This study aim to study the wound complications and scar healing after Surgical staples removal at postoperative day 4 and day 8 .
A randomized control trial.
Detailed description
A randomized controlled trial in which pregnant women undergoing a scheduled Elective cesarean delivery were assigned to skin closure with surgical staples and were randomly assigned to the day of removal of surgical staples. Postoperative day 4 VS. Postoperative day 8 .
Outcome assessors were blinded to group allocation. Scars will be evaluated after 8 weeks. Primary outcome measures is Patient and Observer Scar Assessment Scale (POSAS) scores. Secondary outcome measures are complications of surgical site infection (SSI) or wound disruption (hematoma or seroma).
A group of 104 women is needed in order to achieve a clinically significant effect with a power of 80%.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| POD4 | Other | Other: Removal of surgical clips at day 4 post operative vs day 8 post operative, Procedure: Elective cesarean deliveryREMOVAL OF SURGICAL STAPLES AT POSTOPERATIVE DAY 4 |
| POD8 | Other | Other: Removal of surgical clips at day 4 post operative vs day 8 post operative, Procedure: Elective cesarean deliveryREMOVAL OF SURGICAL STAPLES AT POSTOPERATIVE DAY 8 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- elective cesarean delivery
- previous cesarean delivery performed using the Pfannenstiel method
- 36-41 weeks of gestation based on first trimester ultrasound and a viable fetus.
Key exclusion criteria (4 listed)
- emergency cesarean delivery
- clinical signs of infection at the time of CD, uncontrolled
- vunblanaced diabetes mellitus
- history of keloids
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 |
|---|---|---|
| Removal of surgical clips at day 4 post operative vs day 8 post operativeRemoval of surgical clips at day 4 post operative vs day 8 post operative | Other | POD4, POD8 |
| Elective cesarean deliverynon emergent elective cesarean delivery | Procedure or surgery | POD4, POD8 |
Primary outcome
Patient and Observer Scar Assessment Scale (POSAS) scores.
Time frame: 8 weeks postoperative
1 secondary outcome
complications of surgical site infection (SSI) or wound disruption (hematoma or seroma).
Time frame: 8 weeks postoperative
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 8 May 2018.
- Individual participant dataSharing planned: No
Related trials for Cesarean Section; Wound, Infection (Following Delivery)
Not yet recruiting
The Mepilex Cesarean Delivery Trial / MEPIDEL
Surgical Site Infection
Recruiting
Skin Adhesive Plus Intra-cuticular Suture Versus Suture Alone for Cesarean Skin Closure
Surgical Site Infection (SSI)
Not yet recruitingObservational study
Vaginal Microbiota and Post-cesarean SSI
Site Infection, Cesarean Section; Complications, Wound, Infection (Following Delivery)
Recruiting
Patient Reported Experiences and Outcomes Associated with Standard C-Section Wound Closure Versus STRATAFIX/DERMABOND PRINEO Wound Closure (CS-PREO)
Cesarean Section; Complications, Wound, Infection (Following Delivery)
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.
Hadas Miremberg, MD principal investigator
Wolfson Medical Center- Tel Aviv University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Removal of surgical clips at day 4 post operative vs day 8 post operative and Elective cesarean delivery in people with Cesarean Section; Wound, Infection (Following Delivery), run by Wolfson Medical Center 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 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 8 May 2018. 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?
Patient and Observer Scar Assessment Scale (POSAS) scores. (time frame: 8 weeks postoperative). 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 8 May 2018.