Surgical Site InfectionPhase 3lavageNCT01378832
Effect of Peritoneal Lavage With Clindamycin-gentamicin Solution on Postoperative Colorectal Cancer Infection in Elective Surgery
A Phase 3 study testing Intra-peritoneal antibiotic lavage in people with Surgical Site Infection, run by Universidad Miguel Hernandez de Elche.
Trial summary
Intrabdominal antibiotic irrigation will reduce wound and intrabdominal infection. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Surgical Site Infection
- What is being tested?
- Intra-peritoneal antibiotic lavage
- Type of treatment
- Surgery or procedure
- How many people
- 102 participants
- Where
- No sites listed yet
- Study dates
- Jan 2010to Dec 2010
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- diagnosis of colorectal neoplasms and plans to undergo an elective surgery with curative aims.
Who cannot join
- preoperative diagnosis of chronic renal failure, because of the risk of nephrotoxicity associated with intraperitoneal gentamicin absorption
- an anastomotic leak in the postoperative course
About this study
Official title: Effect of Peritoneal Lavage With Clindamycin-gentamicin Solution on Infection in Elective Surgery
Intrabdominal antibiotic irrigation will reduce wound and intrabdominal infection.
Read the detailed description
A prospective, randomized study was performed between January and December 2010. Patient inclusion criteria were a diagnosis of colorectal neoplasms and plans to undergo an elective curative surgery. Patients were divided into 2 groups: Group 1 (intra-abdominal irrigation with normal saline) and Group 2 (intraperitoneal irrigation with a solution of 240 mg gentamicin and 600 mg clindamycin). The occurrence of wound infections and intra-abdominal abscesses were investigated. Following the anastomosis, a microbiological sample of the peritoneal surface was obtained (sample 1). A second sample was collected following an irrigation with normal saline (sample 2). Finally, the peritoneal cavity was irrigated with a gentamicin-clindamycin solution and a third sample was obtained (sample 3).
- Conditions
- Surgical Site Infection
- Being tested
- Intra-peritoneal antibiotic lavage
- Keywords
- Intra-abdominal abscess, wound infection, colorectal surgery
- Medical subject headings
- Surgical Wound Infection, Abdominal Abscess, Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intra-peritoneal antibiotic lavageProcedure or surgery
The lavage was performed immediately prior to closure of the abdominal wall. Prior to the lavage, a microbiological sample from the peritoneal surface (parietal and visceral) was obtained with a swab (sample 1), followed by a lavage with 500 ml normal saline, similar to the one performed in Group 1. After this lavage, a new microbiological sample was obtained from the peritoneal surface (sample 2), and a second lavage with an antibiotic solution, including gentamicin (240 mg) and clindamycin (600 mg) dissolved in 500 ml normal saline was performed. During this lavage, the solution was allowed to sit in the abdominal cavity for 3 minutes. After aspirating the lavage, a third microbiological sample was obtained in the same way as the two previous ones (sample 3).
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical site infection
Intra-abdominal abscess and wound infection will be investigated during the first 30 days after colorectal surgery
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2011 (estimated)
- Study startJan 2010
- Primary completionDec 2010
- Study completionDec 2010
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 Surgical Site 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Miguel Hernandez de Elche
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01378832
- Sponsor's protocol ID
- jruiztovar
- Acronym
- lavage
- Status last verified
- Jan 2010
- First submitted
- 20 Jun 2011
- Last updated
- 22 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Ruiz-Tovar J, Santos J, Arroyo A, Llavero C, Armananzas L, Lopez-Delgado A, Frangi A, Alcaide MJ, Candela F, Calpena R. Effect of peritoneal lavage with clindamycin-gentamicin solution on infections after elective colorectal cancer surgery. J Am Coll Surg. 2012 Feb;214(2):202-7. doi: 10.1016/j.jamcollsurg.2011.10.014.
PubMed 22265220
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Peritoneal Lavage With Clindamycin-gentamicin Solution on Infection in Elective Surgery
- ClinicalTrials.gov ID
- NCT01378832
- Acronym / sponsor ID
- lavage / jruiztovar
- Conditions
- Surgical Site Infection
- Keywords
- Intra-abdominal abscess, wound infection, colorectal surgery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Universidad Miguel Hernandez de ElcheUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 22 Jun 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.
Intrabdominal antibiotic irrigation will reduce wound and intrabdominal infection.
Detailed description
A prospective, randomized study was performed between January and December 2010. Patient inclusion criteria were a diagnosis of colorectal neoplasms and plans to undergo an elective curative surgery. Patients were divided into 2 groups: Group 1 (intra-abdominal irrigation with normal saline) and Group 2 (intraperitoneal irrigation with a solution of 240 mg gentamicin and 600 mg clindamycin). The occurrence of wound infections and intra-abdominal abscesses were investigated. Following the anastomosis, a microbiological sample of the peritoneal surface was obtained (sample 1). A second sample was collected following an irrigation with normal saline (sample 2). Finally, the peritoneal cavity was irrigated with a gentamicin-clindamycin solution and a third sample was obtained (sample 3).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- diagnosis of colorectal neoplasms and plans to undergo an elective surgery with curative aims.
Key exclusion criteria (2 listed)
- preoperative diagnosis of chronic renal failure, because of the risk of nephrotoxicity associated with intraperitoneal gentamicin absorption
- an anastomotic leak in the postoperative course
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 |
|---|---|---|
| Intra-peritoneal antibiotic lavageThe lavage was performed immediately prior to closure of the abdominal wall. Prior to the lavage, a microbiological sample from the peritoneal surface (parietal and visceral) was obtained with a swab (sample 1), followed by a lavage with 500 ml normal saline, similar to the one performed in Group 1. After this lavage, a new microbiological sample was obtained from the peritoneal surface (sample 2), and a second lavage with an antibiotic solution, including gentamicin (240 mg) and clindamycin (600 mg) dissolved in 500 ml normal saline was performed. During this lavage, the solution was allowed to sit in the abdominal cavity for 3 minutes. After aspirating the lavage, a third microbiological sample was obtained in the same way as the two previous ones (sample 3). | Procedure or surgery | – |
Primary outcome
Surgical site infection
Time frame: 30 days
Intra-abdominal abscess and wound infection will be investigated during the first 30 days after colorectal surgery
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 22 Jun 2011.
- Derived from this study: PubMed 22265220Ruiz-Tovar J, Santos J, Arroyo A, Llavero C, Armananzas L, Lopez-Delgado A, Frangi A, Alcaide MJ, Candela F, Calpena R. Effect of peritoneal lavage with clindamycin-gentamicin solution on infections after elective colorectal cancer surgery. J Am Coll Surg. 2012 Feb;214(2):202-7. doi: 10.1016/j.jamcollsurg.2011.10.014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Intra-peritoneal antibiotic lavage in people with Surgical Site Infection, run by Universidad Miguel Hernandez de Elche.
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 22 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
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?
Surgical site infection (time frame: 30 days). 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 NCT01378832, 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 22 Jun 2011; AzTrials last refreshed its copy on 6 Nov 2026.