Wound InfectionPhase 3SCL01NCT01410175
Comparison of the Impact of Electric Scalpels Versus Cold Scalpels
A Phase 3 study testing Conventional scalpel in people with Wound Infection and Cicatrization, run by Barretos Cancer Hospital at 1 site in Brazil.
Trial summary
Surgical site infection (SSI) is the second commonest hospital infection, despite advances in prevention that have been achieved. According to Fernàndes, experimental studies have demonstrated that incorrect use of electric scalpels may double the rate of SSI during electrocauterization. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Wound Infection, Cicatrization
- What is being tested?
- Conventional scalpel
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 163 participants
- Where
- 1 siteBrazil
- Study dates
- Jul 2010to Jan 2013
- Phase
- Phase 3
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age => 18 yo
- elective abdominal gynecological surgery for the purposes of diagnosis or curative or palliative oncological treatment
Who cannot join
- surgery with manipulation of the digestive system
- cases of re-operation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: "Impact on the Incidence of Surgical Site Infection in Abdominal Gynecological Surgery by Comparing the Skin and Subcutaneous Tissue Incision With Cold Scalpel and Electrocautery in a Period of Two Years."
Surgical site infection (SSI) is the second commonest hospital infection, despite advances in prevention that have been achieved.
According to Fernàndes, experimental studies have demonstrated that incorrect use of electric scalpels may double the rate of SSI during electrocauterization.
Read more
Because of the lack of solid data in the literature, in relation to the impact on SSI of using electric scalpels for making incisions in the skin and all subcutaneous tissues, it was judged to be opportune to conduct the present study.
Objectives:
- To compare the incidence of SSI and other complications of the operative wound among patients undergoing elective abdominal gynecological surgery at Barretos Cancer Hospital, between the use of electric and cold scalpels.
- To identify the incidence of SSI and other complications of the operative wound among patients undergoing elective abdominal gynecological surgery, when using electric scalpels for skin incisions and for subcutaneous incisions.
- To identify the main risk factors for SSI among patients undergoing elective abdominal gynecological surgery.
Read the detailed description
Introduction Surgical site infection (SSI) is the second commonest hospital infection, despite advances in prevention that have been achieved. However, among surgical patients, it is the hospital infection of greatest incidence. In the United States, it has been estimated that around 500,000 cases of SSI occur every year, thus generating an annual cost of more than 1.6 billion dollars.
According to the Centers for Disease Control (CDC), SSI can appear up to 30 days after performing the surgical procedure and up to one year afterwards, when a prosthesis was implanted. SSI is classified as superficial infection when it only affects the skin and subcutaneous tissue at the incision site. It is classified as deep infection when it involves deep structures of the wall and muscle layers of organs and spaces in any part of the anatomy that is opened or manipulated during the surgical procedure, with the exception of the incision.
SSI has a series of consequences. These include increased duration of hospitalization, increased cost of medical and hospital care, increased prescription of broad-spectrum antibiotics (with consequent increased bacterial resistance) and increased postoperative mortality, given that 30% to 40% of deaths during this period result from this type of infection.
The risk factors most frequently correlated with SSI are in connection with the patient and the surgical procedure and include obesity, malnutrition, smoking, age extremes, diabetes, chronic obstructive pulmonary disease, immunosuppression, alcoholism, use of corticoids, potential for contamination of the operative wound, long-duration operations, presence of a foreign body at the surgical site, incorrect administration of antibiotic prophylaxis and poor surgical technique. Thus, the risk of SSI may vary according to the type of surgery and each individual's inherent conditions.
With regard to surgical technique, the points that need to be taken into consideration include careful dissection and manipulation of the tissue so as to minimize the tissue trauma, adequacy of hemostasis to impede formation of hematomas, avoidance of environments favorable to microbe proliferation and excessive use of electric scalpels or their use with higher-than recommended currents, which has a high potential for tissue devitalization. According to Fernàndes, experimental studies have demonstrated that incorrect use of electric scalpels may double the rate of SSI during electrocauterization.
Because of the lack of solid data in the literature, in relation to the impact on SSI of using electric scalpels for making incisions in the skin and all subcutaneous tissues, it was judged to be opportune to conduct the present study.
Objectives:
- To compare the incidence of SSI and other complications of the operative wound among patients undergoing elective abdominal gynecological surgery at Barretos Cancer Hospital, between the use of electric and cold scalpels.
- To identify the incidence of SSI and other complications of the operative wound among patients undergoing elective abdominal gynecological surgery, when using electric scalpels for skin incisions and for subcutaneous incisions.
- To identify the main risk factors for SSI among patients undergoing elective abdominal gynecological surgery.
Methodology:
This is a blinded randomized clinical trial composed of two groups (cold scalpel versus electric scalpel), among patients undergoing elective abdominal gynecological surgery at Barretos Cancer Hospital between July 2010 and July 2012. These patients will fulfill the following inclusion criteria: over 18 years of age, agreement to participate in the study and undergoing elective abdominal gynecological surgery for the purposes of diagnosis or curative or palliative oncological treatment. The following types of patient will be excluded: patients undergoing surgery with manipulation of the digestive system, patients undergoing surgery to open a stoma and cases of reoperation. The randomization will be performed at the time of the surgery by the Research Support Center of Barretos Cancer Hospital, with further subdivision of the patients into two groups, with body mass index (BMI) < 30 and ≥ 30. The cold scalpel and electric scalpel will be used in accordance with the randomization, to open the skin and the subcutaneous cellular tissue. The aponeurosis and peritoneum will be incised using an electric scalpel. The data will be gathered by the investigator, who will make direct observations of the operative wound in order to make diagnoses of SSI after discharge from hospital, with assessments on the 14th and 30th days after the operation. The present project has been approved by the Research Ethics Committee of Barretos Cancer Hospital. Subjects who agree to participate will show their acceptance through signing a free and informed consent statement. Other factors such as hematoma, seroma, bulging, etc., will also be evaluated.
- Conditions
- Wound Infection, Cicatrization
- Being tested
- Conventional scalpel
- Medical subject headings
- Wound Infection, Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional scalpelDevice
Also called Cold scalpel
Use of conventional scalpel to incise the skin and subcutaneous layers.
| Study group | Role | What they receive |
|---|---|---|
| Conventional scalpel | Experimental | Use of conventional scalpel to incise the skin and subcutaneous layer. Receives: Device: Conventional scalpel |
| Electric scalpel | No intervention | Use of electric scalpel to incise the skin and subcutaneous layer. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Surgical Incision Complications
The following complications will be analyzed in those days: site infection, seroma, dehiscence, hematoma, bruise, hyperemia and quality of healing.
Measured: 15 and 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2011 (estimated)
- Study startJul 2010
- Primary completionJul 2012
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 163 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barretos Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Regiane L Rongetti, Principal investigator, Barretos Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01410175
- Sponsor's protocol ID
- SCALPEL 01
- Acronym
- SCL01
- Status last verified
- May 2014
- First submitted
- 21 Jun 2011
- Last updated
- 23 May 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Rongetti RL, Oliveira e Castro Pde T, Vieira RA, Serrano SV, Mengatto MF, Fregnani JH. Surgical site infection: an observer-blind, randomized trial comparing electrocautery and conventional scalpel. Int J Surg. 2014;12(7):681-7. doi: 10.1016/j.ijsu.2014.05.064. Epub 2014 May 24.
PubMed 24866067
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Impact on the Incidence of Surgical Site Infection in Abdominal Gynecological Surgery by Comparing the Skin and Subcutaneous Tissue Incision With Cold Scalpel and Electrocautery in a Period of Two Years."
- ClinicalTrials.gov ID
- NCT01410175
- Acronym / sponsor ID
- SCL01 / SCALPEL 01
- Conditions
- Wound Infection, Cicatrization
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 163 participants (actual)
- Lead sponsor
- Barretos Cancer HospitalUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 4 Aug 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.
Surgical site infection (SSI) is the second commonest hospital infection, despite advances in prevention that have been achieved.
According to Fernàndes, experimental studies have demonstrated that incorrect use of electric scalpels may double the rate of SSI during electrocauterization.
Because of the lack of solid data in the literature, in relation to the impact on SSI of using electric scalpels for making incisions in the skin and all subcutaneous tissues, it was judged to be opportune to conduct the present study.
Objectives:
- To compare the incidence of SSI and other complications of the operative wound among patients undergoing elective abdominal gynecological surgery at Barretos Cancer Hospital, between the use of electric and cold scalpels.
- To identify the incidence of SSI and other complications of the operative wound among patients undergoing elective abdominal gynecological surgery, when using electric scalpels for skin incisions and for subcutaneous incisions.
- To identify the main risk factors for SSI among patients undergoing elective abdominal gynecological surgery.
Detailed description
Introduction Surgical site infection (SSI) is the second commonest hospital infection, despite advances in prevention that have been achieved. However, among surgical patients, it is the hospital infection of greatest incidence. In the United States, it has been estimated that around 500,000 cases of SSI occur every year, thus generating an annual cost of more than 1.6 billion dollars.
According to the Centers for Disease Control (CDC), SSI can appear up to 30 days after performing the surgical procedure and up to one year afterwards, when a prosthesis was implanted. SSI is classified as superficial infection when it only affects the skin and subcutaneous tissue at the incision site. It is classified as deep infection when it involves deep structures of the wall and muscle layers of organs and spaces in any part of the anatomy that is opened or manipulated during the surgical procedure, with the exception of the incision.
SSI has a series of consequences. These include increased duration of hospitalization, increased cost of medical and hospital care, increased prescription of broad-spectrum antibiotics (with consequent increased bacterial resistance) and increased postoperative mortality, given that 30% to 40% of deaths during this period result from this type of infection.
The risk factors most frequently correlated with SSI are in connection with the patient and the surgical procedure and include obesity, malnutrition, smoking, age extremes, diabetes, chronic obstructive pulmonary disease, immunosuppression, alcoholism, use of corticoids, potential for contamination of the operative wound, long-duration operations, presence of a foreign body at the surgical site, incorrect administration of antibiotic prophylaxis and poor surgical technique. Thus, the risk of SSI may vary according to the type of surgery and each individual's inherent conditions.
With regard to surgical technique, the points that need to be taken into consideration include careful dissection and manipulation of the tissue so as to minimize the tissue trauma, adequacy of hemostasis to impede formation of hematomas, avoidance of environments favorable to microbe proliferation and excessive use of electric scalpels or their use with higher-than recommended currents, which has a high potential for tissue devitalization. According to Fernàndes, experimental studies have demonstrated that incorrect use of electric scalpels may double the rate of SSI during electrocauterization.
Because of the lack of solid data in the literature, in relation to the impact on SSI of using electric scalpels for making incisions in the skin and all subcutaneous tissues, it was judged to be opportune to conduct the present study.
Objectives:
- To compare the incidence of SSI and other complications of the operative wound among patients undergoing elective abdominal gynecological surgery at Barretos Cancer Hospital, between the use of electric and cold scalpels.
- To identify the incidence of SSI and other complications of the operative wound among patients undergoing elective abdominal gynecological surgery, when using electric scalpels for skin incisions and for subcutaneous incisions.
- To identify the main risk factors for SSI among patients undergoing elective abdominal gynecological surgery.
Methodology:
This is a blinded randomized clinical trial composed of two groups (cold scalpel versus electric scalpel), among patients undergoing elective abdominal gynecological surgery at Barretos Cancer Hospital between July 2010 and July 2012. These patients will fulfill the following inclusion criteria: over 18 years of age, agreement to participate in the study and undergoing elective abdominal gynecological surgery for the purposes of diagnosis or curative or palliative oncological treatment. The following types of patient will be excluded: patients undergoing surgery with manipulation of the digestive system, patients undergoing surgery to open a stoma and cases of reoperation. The randomization will be performed at the time of the surgery by the Research Support Center of Barretos Cancer Hospital, with further subdivision of the patients into two groups, with body mass index (BMI) < 30 and ≥ 30. The cold scalpel and electric scalpel will be used in accordance with the randomization, to open the skin and the subcutaneous cellular tissue. The aponeurosis and peritoneum will be incised using an electric scalpel. The data will be gathered by the investigator, who will make direct observations of the operative wound in order to make diagnoses of SSI after discharge from hospital, with assessments on the 14th and 30th days after the operation. The present project has been approved by the Research Ethics Committee of Barretos Cancer Hospital. Subjects who agree to participate will show their acceptance through signing a free and informed consent statement. Other factors such as hematoma, seroma, bulging, etc., will also be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional scalpel | Experimental | Device: Conventional scalpelUse of conventional scalpel to incise the skin and subcutaneous layer. |
| Electric scalpel | No intervention | –Use of electric scalpel to incise the skin and subcutaneous layer. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age => 18 yo
- elective abdominal gynecological surgery for the purposes of diagnosis or curative or palliative oncological treatment
Key exclusion criteria (2 listed)
- surgery with manipulation of the digestive system
- cases of re-operation
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 |
|---|---|---|
| Conventional scalpelAlso: Cold scalpelUse of conventional scalpel to incise the skin and subcutaneous layers. | Device | Conventional scalpel |
Primary outcome
Change in Surgical Incision Complications
Time frame: 15 and 30 days after surgery
The following complications will be analyzed in those days: site infection, seroma, dehiscence, hematoma, bruise, hyperemia and quality of healing.
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 23 May 2014.
- Derived from this study: PubMed 24866067Rongetti RL, Oliveira e Castro Pde T, Vieira RA, Serrano SV, Mengatto MF, Fregnani JH. Surgical site infection: an observer-blind, randomized trial comparing electrocautery and conventional scalpel. Int J Surg. 2014;12(7):681-7. doi: 10.1016/j.ijsu.2014.05.064. Epub 2014 May 24.
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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.
Regiane L Rongetti principal investigator
Barretos Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Conventional scalpel in people with Wound Infection and Cicatrization, run by Barretos Cancer Hospital at 1 site in Brazil.
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 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 23 May 2014. 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 Brazil. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change in Surgical Incision Complications (time frame: 15 and 30 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01410175, which also lists 1 linked publication.
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 23 May 2014.