Hysterotomy ClosureStratafixNCT02517710
Study to Compare Suture Material in Closure of Uterine Incision in Cesarian Section
A study testing Stratafix synthetic barbed suture in people with Hysterotomy Closure, run by Evangelical Community Hospital, Lewisburg, PA at 1 site in United States.
Trial summary
Prospective single blinded trial comparing standard synthetic suture material to a synthetic barbed suture in closure of uterine incision, during Cesarean section procedures. Read more about this study
- Who is it for?
- Ages 16 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hysterotomy Closure
- What is being tested?
- Stratafix synthetic barbed suture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to 31 Dec 2016
- 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 16 to 50 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Women of childbearing age undergoing primary or repeat cesarean section using regional anesthesia.
Who cannot join
- General Anesthesia
- Non-consent to participation
Trial locations and contacts
1 site in 1 country.
United States1 site
Evangelical Community Hospital
Lewisburg, Pennsylvania, 17837
About this study
Official title: Single-blinded Prospective Trial Comparing Quantitive Blood Loss, Operative Time, and Post Operative Pain Using Stratafix Barbed Suture in Cesarian Section to the Use of Traditional Suture Material
Prospective single blinded trial comparing standard synthetic suture material to a synthetic barbed suture in closure of uterine incision, during Cesarean section procedures.
Read the detailed description
Cesarean section is one of the most common medical procedures women of child bearing age undergo, in the United States and the world. This trial is designed to provide information and possible recommendation as to suture material used during closure of the uterus during that procedure. Our intent is to provide data relating to time of uterine closure, blood loss, and post operative pain. These conclusions may provide substantiated recommendations as to self locking and tying suture material in the performance of cesarean section as related to readily available synthetic suture material, which has the need for standard suture knot placement.
- Conditions
- Hysterotomy Closure
- Being tested
- Stratafix synthetic barbed suture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stratafix synthetic barbed sutureProcedure or surgery
hysterotomy closure in Cesarian section
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Group of patients receiving standard hysterotomy closure with synthetic braided suture Receives: Procedure: Stratafix synthetic barbed suture |
| Stratfix | Experimental | group of patients having the hysterotomy incision closed with barbed synthetic suture. Time to closure, blood loss, and postoperative pain Receives: Procedure: Stratafix synthetic barbed suture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood loss in closure with barbed synthetic suture
monitoring of preoperative and postoperative hemoglobin and hematcrit
Measured: 2 days
Secondary outcomes (1)
Post operative pain after cesarean secton
using visual analog pain scale, compare standard closure to barbed suture closure pain
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2015 (estimated)
- Study startApr 2014
- Primary completion31 Dec 2016
- Study completion31 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hysterotomy ClosureStudies 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
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Evangelical Community Hospital, Lewisburg, PA
- Sponsor type
- University, hospital or other
- Collaborators
- Russell J.Stankiewicz, MD, Ob/GYN Associates of Evangelical Hospital, The Commonwealth Medical College, Nickolas Serniak, BS, MS 4, Neil Cooper, MS, MS 4, Jennifer L. MacDonald, PA
- Responsible party
- Principal investigator, Russell J. Stankiewicz, MD, Evangelical Community Hospital, Lewisburg, PA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02517710
- Sponsor's protocol ID
- ECH/TCMC101
- Acronym
- Stratafix
- Status last verified
- Aug 2018
- First submitted
- 9 Oct 2014
- Last updated
- 10 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-blinded Prospective Trial Comparing Quantitive Blood Loss, Operative Time, and Post Operative Pain Using Stratafix Barbed Suture in Cesarian Section to the Use of Traditional Suture Material
- ClinicalTrials.gov ID
- NCT02517710
- Acronym / sponsor ID
- Stratafix / ECH/TCMC101
- Conditions
- Hysterotomy Closure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Evangelical Community Hospital, Lewisburg, PAUniversity, hospital or other
- Collaborators
- Russell J.Stankiewicz, MD, Ob/GYN Associates of Evangelical Hospital, The Commonwealth Medical College, Nickolas Serniak, BS, MS 4, Neil Cooper, MS, MS 4, Jennifer L. MacDonald, PA
- Study start
- Apr 2014
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 7 Aug 2015 (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.
Prospective single blinded trial comparing standard synthetic suture material to a synthetic barbed suture in closure of uterine incision, during Cesarean section procedures.
Detailed description
Cesarean section is one of the most common medical procedures women of child bearing age undergo, in the United States and the world. This trial is designed to provide information and possible recommendation as to suture material used during closure of the uterus during that procedure. Our intent is to provide data relating to time of uterine closure, blood loss, and post operative pain. These conclusions may provide substantiated recommendations as to self locking and tying suture material in the performance of cesarean section as related to readily available synthetic suture material, which has the need for standard suture knot placement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Procedure: Stratafix synthetic barbed sutureGroup of patients receiving standard hysterotomy closure with synthetic braided suture |
| Stratfix | Experimental | Procedure: Stratafix synthetic barbed suturegroup of patients having the hysterotomy incision closed with barbed synthetic suture. Time to closure, blood loss, and postoperative pain |
Who may qualify
- Ages
- 16 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Women of childbearing age undergoing primary or repeat cesarean section using regional anesthesia.
Key exclusion criteria (2 listed)
- General Anesthesia
- Non-consent to participation
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 |
|---|---|---|
| Stratafix synthetic barbed suturehysterotomy closure in Cesarian section | Procedure or surgery | Control, Stratfix |
Primary outcome
Blood loss in closure with barbed synthetic suture
Time frame: 2 days
monitoring of preoperative and postoperative hemoglobin and hematcrit
1 secondary outcome
Post operative pain after cesarean secton
Time frame: 3 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 10 Aug 2018.
Related trials for Hysterotomy Closure
Recruiting
Niche Investigated: Closure of Hysterotomy & Evaluation of 3 Suturing Techniques (Running, Interrupted, and Locked)
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Recruiting
Impact of Single- Versus Double-layer Hysterotomy Closure on Cesarean Niche Development: a Randomized Controlled Trial
Cesarean Section; Dehiscence, Uterine Bleeding
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 Stratafix synthetic barbed suture in people with Hysterotomy Closure, run by Evangelical Community Hospital, Lewisburg, PA 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 2 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 10 Aug 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 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. Some participants in this study may receive a placebo. 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?
Blood loss in closure with barbed synthetic suture (time frame: 2 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 10 Aug 2018.