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Quick Skin Sealant in Closure of Surgical Wound After Laparoscopic Surgery

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ClinicalTrials.gov Identifier: NCT02426762
Recruitment Status : Unknown
Verified August 2015 by Wu Song, First Affiliated Hospital, Sun Yat-Sen University.
Recruitment status was:  Recruiting
First Posted : April 27, 2015
Last Update Posted : August 13, 2015
Sponsor:
Information provided by (Responsible Party):
Wu Song, First Affiliated Hospital, Sun Yat-Sen University

Brief 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.

Condition or disease Intervention/treatment Phase
Complications of Surgical Procedures Surgical Site Infection Gastric Cancer Colorectal Cancer Gastrointestinal Stromal Tumor Inflammatory Bowel Disease Diverticula Procedure: Laparoscopic surgery Device: Skin sealant Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Use of a Quick Skin Sealant in Prevention of Surgical Site Infection After Laparoscopic Tumor Resection
Study Start Date : February 2015
Estimated Primary Completion Date : October 2015
Estimated Study Completion Date : October 2015


Arm Intervention/treatment
Experimental: Sealant skin closure
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.
Procedure: Laparoscopic 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)

Device: Skin sealant
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.
Other Name: Skin adhesive




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Length of hospital stay [ Time Frame: an expected average of 4 weeks ]
    All participants will be followed for the duration of hospital stay, an expected average of 4 weeks

  2. Pain Scores on the Visual Analog Scale [ Time Frame: within the first 30 days after laparoscopic surgery ]
    Postoperative pain would be recorded.



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Ages Eligible for Study:   16 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02426762


Contacts
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Contact: Yujie Yuan, MD +8615018492852 condor.yyj@gmail.com

Locations
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China, Guangdong
The First Affiliated Hospital of Sun Yat-sen University Recruiting
Guangzhou, Guangdong, China, 510000
Contact: Yujie Yuan, MD    +86 15018492852    condor.yyj@gmail.com   
Sponsors and Collaborators
First Affiliated Hospital, Sun Yat-Sen University
Investigators
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Principal Investigator: Wu Song, MD First Affiliated Hospital, Sun Yat-Sen University
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Responsible Party: Wu Song, Director of Center of Gastrointestinal Surgery, First Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier: NCT02426762    
Other Study ID Numbers: 2015[122]
First Posted: April 27, 2015    Key Record Dates
Last Update Posted: August 13, 2015
Last Verified: August 2015
Keywords provided by Wu Song, First Affiliated Hospital, Sun Yat-Sen University:
skin sealant
laparoscopic surgery
surgical site infection
wound healing
Additional relevant MeSH terms:
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Infection
Surgical Wound Infection
Diverticulum
Gastrointestinal Stromal Tumors
Inflammatory Bowel Diseases
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Gastroenteritis
Wound Infection
Postoperative Complications
Pathologic Processes
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Diverticular Diseases
Intraabdominal Infections
Pathological Conditions, Anatomical