Surgical Wound InfectionNCT02332252
Electrocautery Versus Scalpel for Surgical Skin Incisions in Cesarean Section.
A study testing Scalpel, Electrocautery and Skin incision in people with Surgical Wound Infection, run by Saint Thomas Hospital, Panama at 1 site in Panama.
Trial summary
To determine the risk of surgical site infection after surgical skin incision, comparing electrocautery vs. scalpel. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Surgical Wound Infection
- What is being tested?
- Scalpel, Electrocautery and Skin incision
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 sitePanama
- Study dates
- Aug 2015to Aug 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Elective Cesarean section, regardless of gestational age.
Who cannot join
- Skin infection in the cesarean section area.
- Emergency cesarean section.
- Presence of a maternal pathology that increases the risk of infection (immunocompromised state).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Electrocautery Versus Scalpel for Surgical Skin Incisions in Cesarean Section. A Randomized Controlled Trial.
To determine the risk of surgical site infection after surgical skin incision, comparing electrocautery vs. scalpel.
- Conditions
- Surgical Wound Infection
- Being tested
- Scalpel, Electrocautery, Skin incision
- Keywords
- Surgical Wound Infection, Electrocautery, Scalpel
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ScalpelDevice
Skin incision performed with a scalpel during cesarean section.
ElectrocauteryDevice
Skin incision performed with an electrocautery during cesarean section.
Skin incisionProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Scalpel | Active comparator | Skin incision performed with a scalpel during cesarean section. Receives: Device: Scalpel; Procedure: Skin incision |
| Electrocautery | Experimental | Skin incision performed with an electrocautery during cesarean section. Receives: Device: Electrocautery; Procedure: Skin incision |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical Site Infection
Presence of signs of surgical site infection after cesarean section.
Measured: 8 days
Secondary outcomes (1)
Post operative pain
Post operative pain using a visual scale after surgery.
Measured: 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2015 (estimated)
- Study startAug 2015
- Primary completionFeb 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Wound InfectionStudies 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
- None (open label)
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saint Thomas Hospital, Panama
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Osvaldo A. Reyes T., Saint Thomas Hospital, Panama
- Investigators
- Osvaldo Reyes, MD, Principal investigator, Saint Thomas Hospital, Panama
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02332252
- Sponsor's protocol ID
- MHST2014-10
- Status last verified
- Jan 2018
- First submitted
- 4 Jan 2015
- Last updated
- 4 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrocautery Versus Scalpel for Surgical Skin Incisions in Cesarean Section. A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT02332252
- Acronym / sponsor ID
- MHST2014-10
- Conditions
- Surgical Wound Infection
- Keywords
- Surgical Wound Infection, Electrocautery, Scalpel
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Saint Thomas Hospital, PanamaUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Feb 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 6 Jan 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.
To determine the risk of surgical site infection after surgical skin incision, comparing electrocautery vs. scalpel.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Scalpel | Active comparator | Device: Scalpel, Procedure: Skin incisionSkin incision performed with a scalpel during cesarean section. |
| Electrocautery | Experimental | Device: Electrocautery, Procedure: Skin incisionSkin incision performed with an electrocautery during cesarean section. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Elective Cesarean section, regardless of gestational age.
Key exclusion criteria (3 listed)
- Skin infection in the cesarean section area.
- Emergency cesarean section.
- Presence of a maternal pathology that increases the risk of infection (immunocompromised state).
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 |
|---|---|---|
| ScalpelSkin incision performed with a scalpel during cesarean section. | Device | Scalpel |
| ElectrocauterySkin incision performed with an electrocautery during cesarean section. | Device | Electrocautery |
| Skin incision | Procedure or surgery | Electrocautery, Scalpel |
Primary outcome
Surgical Site Infection
Time frame: 8 days
Presence of signs of surgical site infection after cesarean section.
1 secondary outcome
Post operative pain
Time frame: 8 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 4 Jan 2018.
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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.
Osvaldo Reyes, MD principal investigator
Saint Thomas Hospital, Panama
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Scalpel, Electrocautery and Skin incision in people with Surgical Wound Infection, run by Saint Thomas Hospital, Panama at 1 site in Panama.
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 3 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 4 Jan 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 Panama. 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?
Surgical Site Infection (time frame: 8 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 4 Jan 2018.