Trial record 11 of 26 for:    colostomy | Open Studies

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Beijing Chao Yang Hospital
Sponsor:
Information provided by (Responsible Party):
Zhen Jun Wang, Beijing Chao Yang Hospital
ClinicalTrials.gov Identifier:
NCT02053948
First received: November 26, 2013
Last updated: February 3, 2014
Last verified: February 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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

Further study details as provided by Beijing Chao Yang Hospital:

Primary Outcome Measures:
  • superficial wound infection of stoma site [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Healing time after stoma reversal [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Patient's satisfaction about the wound after stoma reversal [ Time Frame: 1 year ] [ Designated as safety issue: No ]

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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • loop colostomy
  • end colostomy

Exclusion Criteria:

  • other stomy
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 Chaoyang 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
Study First Received: November 26, 2013
Last Updated: February 3, 2014
Health Authority: China: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 14, 2014