Wound InfectionNCT01446627
Use of Insorb Absorbable Vicryl Staples in Skin Closure for Cesarean Section
An observational study of Wound Infection, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the incidence of wound breakdown or wound infection following skin closure with Insorb subcuticular absorbable staples versus metal staples after cesarean section through a retrospective chart analysis. Read more about this study
- Who is it for?
- Ages 14 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Wound Infection
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Dec 2012
- 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 14 to 50 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: Women undergoing cesarean section who have their skin incision closed with staples.
Who may be able to join
- Cesarean sections
- UT patients
Who cannot join
- Patients who have skin closed with suture, per attending choice.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Vicryl Absorbable Sutures and Metal Staples Used in Skin Closure Following Cesarean Section
The purpose of this study is to evaluate the incidence of wound breakdown or wound infection following skin closure with Insorb subcuticular absorbable staples versus metal staples after cesarean section through a retrospective chart analysis.
Read the detailed description
Procedures:
A list will be compiled of patients who underwent cesarean section at Memorial Hermann Hospital in the Texas Medical Center from January 1st 2010 through January 1st 2011. Only UT patients who had their skin closed with Insorb or metal staples will be included in this list. Patients' clinical charts will be reviewed for post-operative follow-up, and notes will be made of the wound assessment. Any complications such as infection, seroma, hematoma, and wound separation or delayed healing will be recorded. Additional notes will be made of any co-morbid conditions, including, but not limited to, >30 BMI, chronic hypertension, diabetes mellitus, HIV, history of tobacco use.
Once the data is gathered, it will be compared with published national averages to determine if there is an increased risk of wound separation or wound infection at our institution. In addition, rated of infection and wound breakdown following closure with either absorbable or metal staples will be compared by Fisher's exact test, to determine statistical significance.
Course of Study: Data will be obtained from UT patients who underwent cesarean section from January 1st, 2010 through January 1st, 2011. Only patients who had skin closure with InSorb or metal staples will be included in analysis.
- Conditions
- Wound Infection
- Being tested
- There is no intervention for this study
- Keywords
- Absorbable vicryl subcuticular staples, metal staples, wound healing, cesarean section
- Medical subject headings
- Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
There is no intervention for this studyOther
Also called This is an observational study, involving human subjects. It is a clinical study, but not a clinical trial. No intervention will be made.
None, no intervention made.
| Study group | Role | What they receive |
|---|---|---|
| metal staples | Not described Receives: Other: There is no intervention for this study | |
| Insorb vicryl staples | Not described Receives: Other: There is no intervention for this study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound infection/separation
Measured: from time of surgery up until wound assessed to be completely healed, no longer than 1 year.
Secondary outcomes (2)
wound hematoma
Measured: From time of surgery up until wound assessed to be completely healed, no longer than 1 year.
wound seroma
Measured: From time of surgery up until wound assessed to be completely healed, no longer than 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2011 (estimated)
- Study startJan 2010
- Primary completionJan 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound InfectionStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonathan P Faro, The University of Texas Health Science Center, Houston
- Investigators
- Jonathan P Faro, MD, PhD, Principal investigator, UTHSC at Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01446627
- Sponsor's protocol ID
- HSC-GEN-11-0169
- Status last verified
- May 2013
- First submitted
- 30 Sep 2011
- Last updated
- 3 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Vicryl Absorbable Sutures and Metal Staples Used in Skin Closure Following Cesarean Section
- ClinicalTrials.gov ID
- NCT01446627
- Acronym / sponsor ID
- HSC-GEN-11-0169
- Conditions
- Wound Infection
- Keywords
- Absorbable vicryl subcuticular staples, metal staples, wound healing, cesarean section
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Jan 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 5 Oct 2011 (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.
The purpose of this study is to evaluate the incidence of wound breakdown or wound infection following skin closure with Insorb subcuticular absorbable staples versus metal staples after cesarean section through a retrospective chart analysis.
Detailed description
Procedures:
A list will be compiled of patients who underwent cesarean section at Memorial Hermann Hospital in the Texas Medical Center from January 1st 2010 through January 1st 2011. Only UT patients who had their skin closed with Insorb or metal staples will be included in this list. Patients' clinical charts will be reviewed for post-operative follow-up, and notes will be made of the wound assessment. Any complications such as infection, seroma, hematoma, and wound separation or delayed healing will be recorded. Additional notes will be made of any co-morbid conditions, including, but not limited to, >30 BMI, chronic hypertension, diabetes mellitus, HIV, history of tobacco use.
Once the data is gathered, it will be compared with published national averages to determine if there is an increased risk of wound separation or wound infection at our institution. In addition, rated of infection and wound breakdown following closure with either absorbable or metal staples will be compared by Fisher's exact test, to determine statistical significance.
Course of Study: Data will be obtained from UT patients who underwent cesarean section from January 1st, 2010 through January 1st, 2011. Only patients who had skin closure with InSorb or metal staples will be included in analysis.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| metal staples | – | Other: There is no intervention for this study |
| Insorb vicryl staples | – | Other: There is no intervention for this study |
Who may qualify
- Ages
- 14 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Women undergoing cesarean section who have their skin incision closed with staples.
Key inclusion criteria (2 listed)
- Cesarean sections
- UT patients
Key exclusion criteria (1 listed)
- Patients who have skin closed with suture, per attending choice.
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 |
|---|---|---|
| There is no intervention for this studyAlso: This is an observational study, involving human subjects. It is a clinical study, but not a clinical trial. No intervention will be made.None, no intervention made. | Other | Insorb vicryl staples, metal staples |
Primary outcome
Wound infection/separation
Time frame: from time of surgery up until wound assessed to be completely healed, no longer than 1 year.
2 secondary outcomes
wound hematoma
Time frame: From time of surgery up until wound assessed to be completely healed, no longer than 1 year.
wound seroma
Time frame: From time of surgery up until wound assessed to be completely healed, no longer than 1 year.
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 3 May 2013.
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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.
Jonathan P Faro, MD, PhD principal investigator
UTHSC at Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Wound Infection, run by The University of Texas Health Science Center, Houston 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 2 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: finished, as of the sponsor's last update on 3 May 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 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 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 infection/separation (time frame: from time of surgery up until wound assessed to be completely healed, no longer than 1 year.). 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 3 May 2013.