Complications of Surgical ProceduresPhase 2NCT02426762
Quick Skin Sealant in Closure of Surgical Wound After Laparoscopic Surgery
A Phase 2 study testing Laparoscopic surgery and Skin sealant in people with Complications of Surgical Procedures and Surgical Site Infection, run by First Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
Trial summary
The purpose of this study is to evaluate the short-term effect of sealant-assisted skin closure in prevention of surgical site infection after laparoscopic surgery. Read more about this study
- Who is it for?
- Ages 16 to 65 years
- Conditions the study is for
- Complications of Surgical Procedures, Surgical Site Infection, Gastric Cancer
- What is being tested?
- Laparoscopic surgery and Skin sealant
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Feb 2015to Oct 2015
- Phase
- Phase 2
- 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 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- The informed consent has been obtained from the patient.
- With confirmed diagnosis of gastric cancer, colorectal cancer, gastrointestinal stromal tumor, inflammatory bowel disease and diverticula.
- Endurable laparoscopic surgery without conversion.
- With moderate/good ECOG health rating (PS): 0-1 score.
Who cannot join
- Pregnant woman or lactating woman.
- With confirmed distant metastasis in liver, lung, bones, or other organs.
- Intolerable laparoscopic operation or converted to open surgery.
- With severe comorbidities, such as cardiovascular disease, chronic obstructive pulmonary disease, diabetes mellitus, and chronic renal dysfunction.
- With bad compliance or contraindication to enrollment.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510000
Yujie Yuan, MD, +86 15018492852, condor.yyj@gmail.com
About this study
Official title: Use of a Quick Skin Sealant in Prevention of Surgical Site Infection After Laparoscopic Tumor Resection
The purpose of this study is to evaluate the short-term effect of sealant-assisted skin closure in prevention of surgical site infection after laparoscopic surgery.
Read the detailed description
- Study design: A prospective cohort study
- Populations: Patients who have confirmed diagnosis of gastric cancer, colorectal cancer, gastrointestinal stromal tumor (GIST), inflammatory bowel disease and diverticula decide to receive laparoscopic surgery.
- Surgical techniques: laparoscopic operations should be successfully performed with a 3-4 cm minimal incision left for sample retrieval. In all, about five trocar-associated mini incisions and a sample-retrieval incision would be left prior to skin closure.
- Skin closure: A quick skin sealant would be applied to achieve a seal, without any suture made under the skin.
- Postoperative treatment: An enhanced recovery after surgery (ERAS) bundles would be applied for enrolled subjects. As for wound management, additional wound cares are not required. Patients can take shower at postoperative day 3 (POD3).
- Primary endpoint: The primary study endpoint is freedom from surgical site infection (SSI) within 30 days. The incidence of surgical site infection with the first 30 days after surgery would be explored.
- Conditions
- Complications of Surgical Procedures, Surgical Site Infection, Gastric Cancer, Colorectal Cancer, Gastrointestinal Stromal Tumor, Inflammatory Bowel Disease
- Being tested
- Laparoscopic surgery, Skin sealant
- Keywords
- skin sealant, laparoscopic surgery, surgical site infection, wound healing
- Medical subject headings
- Surgical Wound Infection, Stomach Neoplasms, Colorectal Neoplasms, Gastrointestinal Stromal Tumors, Inflammatory Bowel Diseases, Diverticulum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic surgeryProcedure or surgery
Various laparoscopic operations are performed for participants. Once all surgical procedures are successfully applied, surgical wounds which are associated with laparoscopic surgery would be sealed by a quick sealant. In all, the following surgical wounds would be left:
- 4-5 trocar-produced incisions (5/10mm, minor incision)
- 1 sample-retrieval incision (4-5cm, small incision)
Skin sealantDevice
Also called Skin adhesive
After surgery, a quick skin sealant is applied in two layers of each wound to achieve skin closure. The sealant would be smeared twice on the wound area with 30 seconds of dry time required to form a firm seal.
| Study group | Role | What they receive |
|---|---|---|
| Sealant skin closure | Experimental | A quick skin sealant would be applied after laparoscopic surgery. All abdominal wounds are sealed by smearing the quick sealant (skin adhesive) twice. No additional gauges should be appended on wound areas. No further wound care should be applied unless any effusion or bleeding emerged around it. Receives: Procedure: Laparoscopic surgery; Device: Skin sealant |
What is being measured
The primary outcome is the main question the study is designed to answer.
freedom from surgical site infection
The study endpoint should be freedom from superficial surgical site infection (SSI) or deep SSI as defined by the Centers of Disease Control and Prevention National Nosocomial Infection Surveillance criteria.
Measured: within the first 30 days after laparoscopic surgery
Secondary outcomes (2)
Length of hospital stay
All participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Measured: an expected average of 4 weeks
Pain Scores on the Visual Analog Scale
Postoperative pain would be recorded.
Measured: within the first 30 days after laparoscopic surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2015 (estimated)
- Study startFeb 2015
- Primary completionOct 2015 (estimated)
- Study completionOct 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complications of Surgical ProceduresStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital, Sun Yat-Sen UniversityThe 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wu Song, First Affiliated Hospital, Sun Yat-Sen University
- Investigators
- Wu Song, MD, Principal investigator, First Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02426762
- Sponsor's protocol ID
- 2015[122]
- Status last verified
- Aug 2015
- First submitted
- 22 Apr 2015
- Last updated
- 13 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of a Quick Skin Sealant in Prevention of Surgical Site Infection After Laparoscopic Tumor Resection
- ClinicalTrials.gov ID
- NCT02426762
- Acronym / sponsor ID
- 2015[122]
- Conditions
- Complications of Surgical Procedures, Surgical Site Infection, Gastric Cancer, Colorectal Cancer, Gastrointestinal Stromal Tumor, Inflammatory Bowel Disease
- Keywords
- skin sealant, laparoscopic surgery, surgical site infection, wound healing
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- First Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Oct 2015 (estimated)
- Study completion
- Oct 2015 (estimated)
- First posted
- 27 Apr 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.
The purpose of this study is to evaluate the short-term effect of sealant-assisted skin closure in prevention of surgical site infection after laparoscopic surgery.
Detailed description
- Study design: A prospective cohort study
- Populations: Patients who have confirmed diagnosis of gastric cancer, colorectal cancer, gastrointestinal stromal tumor (GIST), inflammatory bowel disease and diverticula decide to receive laparoscopic surgery.
- Surgical techniques: laparoscopic operations should be successfully performed with a 3-4 cm minimal incision left for sample retrieval. In all, about five trocar-associated mini incisions and a sample-retrieval incision would be left prior to skin closure.
- Skin closure: A quick skin sealant would be applied to achieve a seal, without any suture made under the skin.
- Postoperative treatment: An enhanced recovery after surgery (ERAS) bundles would be applied for enrolled subjects. As for wound management, additional wound cares are not required. Patients can take shower at postoperative day 3 (POD3).
- Primary endpoint: The primary study endpoint is freedom from surgical site infection (SSI) within 30 days. The incidence of surgical site infection with the first 30 days after surgery would be explored.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sealant skin closure | Experimental | Procedure: Laparoscopic surgery, Device: Skin sealantA quick skin sealant would be applied after laparoscopic surgery. All abdominal wounds are sealed by smearing the quick sealant (skin adhesive) twice. No additional gauges should be appended on wound areas. No further wound care should be applied unless any effusion or bleeding emerged around it. |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- The informed consent has been obtained from the patient.
- With confirmed diagnosis of gastric cancer, colorectal cancer, gastrointestinal stromal tumor, inflammatory bowel disease and diverticula.
- Endurable laparoscopic surgery without conversion.
- With moderate/good ECOG health rating (PS): 0-1 score.
Key exclusion criteria (5 listed)
- Pregnant woman or lactating woman.
- With confirmed distant metastasis in liver, lung, bones, or other organs.
- Intolerable laparoscopic operation or converted to open surgery.
- With severe comorbidities, such as cardiovascular disease, chronic obstructive pulmonary disease, diabetes mellitus, and chronic renal dysfunction.
- With bad compliance or contraindication to enrollment.
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 |
|---|---|---|
| Laparoscopic surgeryVarious laparoscopic operations are performed for participants. Once all surgical procedures are successfully applied, surgical wounds which are associated with laparoscopic surgery would be sealed by a quick sealant. In all, the following surgical wounds would be left: * 4-5 trocar-produced incisions (5/10mm, minor incision) * 1 sample-retrieval incision (4-5cm, small incision) | Procedure or surgery | Sealant skin closure |
| Skin sealantAlso: Skin adhesiveAfter surgery, a quick skin sealant is applied in two layers of each wound to achieve skin closure. The sealant would be smeared twice on the wound area with 30 seconds of dry time required to form a firm seal. | Device | Sealant skin closure |
Primary outcome
freedom from surgical site infection
Time frame: within the first 30 days after laparoscopic surgery
The study endpoint should be freedom from superficial surgical site infection (SSI) or deep SSI as defined by the Centers of Disease Control and Prevention National Nosocomial Infection Surveillance criteria.
2 secondary outcomes
Length of hospital stay
Time frame: an expected average of 4 weeks
Pain Scores on the Visual Analog Scale
Time frame: within the first 30 days after laparoscopic surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2015.
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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.
Wu Song, MD principal investigator
First Affiliated Hospital, Sun Yat-Sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Laparoscopic surgery and Skin sealant in people with Complications of Surgical Procedures and Surgical Site Infection, run by First Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 13 Aug 2015. 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 China. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yujie Yuan, MD (+8615018492852, condor.yyj@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
freedom from surgical site infection (time frame: within the first 30 days after laparoscopic surgery). 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 13 Aug 2015.