We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Pursestring Wound Closure vs "Gunsight" Skin Incision and Closure Technique to Reverse Stoma (GSICT1126)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2014 by Zhen Jun Wang, Beijing Chao Yang Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT02053948
First Posted: February 4, 2014
Last Update Posted: February 4, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Zhen Jun Wang, Beijing Chao Yang Hospital
  Purpose
The use of temporary stomas has been demonstrated to reduce septic complications after colorectal cancer surgery, especially in high-risk anastomosis; therefore, it is necessary to reduce the number of complications secondary to ostomy takedowns, namely wound infection. The aim of this study is to compare the rates of superficial wound infection, healing time and patient satisfaction after pursestring closure vs "gunsight" skin incision and closure technique closure.

Condition Intervention
Colostomy Procedure: Pursestring Wound Closure Procedure: Gunsight Skin Incision and Closure Technique

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Randomized Clinical Trial of Stoma Reversal Comparing Pursestring Wound Closure vs "Gunsight" Skin Incision and Closure Technique to Eliminate the Risk of Wound Infection

Resource links provided by NLM:


Further study details as provided by Zhen Jun Wang, Beijing Chao Yang Hospital:

Primary Outcome Measures:
  • superficial wound infection of stoma site [ Time Frame: 1 year ]

Secondary Outcome Measures:
  • Healing time after stoma reversal [ Time Frame: 1 year ]

Other Outcome Measures:
  • Patient's satisfaction about the wound after stoma reversal [ Time Frame: 1 year ]

Estimated Enrollment: 60
Study Start Date: November 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pursestring Wound Closure group
use Pursestring Wound Closure technique to close the stoma
Procedure: Pursestring Wound Closure
Experimental: Gunsight Skin Incision and Closure group
use Gunsight Skin Incision and Closure Technique to close the stoma
Procedure: Gunsight Skin Incision and Closure Technique

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • loop colostomy
  • end colostomy

Exclusion Criteria:

  • other stomy
  Contacts and Locations
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): NCT02053948


Locations
China, Beijing
Beijing Chaoyang Hospital Recruiting
Beijing, Beijing, China, 100020
Contact: Jiagang Han, Professor    8613522867841    hjg211@163.com   
Principal Investigator: Jiagang Han, Professor         
Principal Investigator: Zhenjun Wang, professor         
Sub-Investigator: Guanghui WEI, Professor         
Sponsors and Collaborators
Beijing Chao Yang Hospital
Investigators
Principal Investigator: Jiagang Han, Professor Beijing Chao Yang Hospital
  More Information

Additional Information:
Publications:
Responsible Party: Zhen Jun Wang, Professor, Beijing Chao Yang Hospital
ClinicalTrials.gov Identifier: NCT02053948     History of Changes
Other Study ID Numbers: GSICT1126
First Submitted: November 26, 2013
First Posted: February 4, 2014
Last Update Posted: February 4, 2014
Last Verified: February 2014

Keywords provided by Zhen Jun Wang, Beijing Chao Yang Hospital:
Reversal
Surgical technique
Pursestring Wound Closure
Gunsight Skin Incision and Closure Technique

Additional relevant MeSH terms:
Surgical Wound
Wounds and Injuries