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NCT02053948 Clinical Trial

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

Colostomy Clinical Trial

— GSICT1126  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02053948
Other study ID # GSICT1126
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 30, 2013
Est. completion date December 30, 2017

Study information
Verified date September 2019
Source Beijing Chao Yang Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 143
Est. completion date December 30, 2017
Est. primary completion date December 30, 2017
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- loop colostomy

- end colostomy

Exclusion Criteria:

- other stomy

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Pursestring Wound Closure

• Gunsight Skin Incision and Closure Technique

Locations
Country Name City State
China Beijing Chaoyang Hospital Beijing Beijing

Sponsors (11)
Lead Sponsor Collaborator
Beijing Chao Yang Hospital Beijing Friendship Hospital, Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Chinese PLA General Hospital, First Hospital of China Medical University, Hebei Medical University Fourth Hospital, Jinling Hospital, China, Peking Union Medical College Hospital, Peking University People's Hospital, Shengjing Hospital, Sixth Affiliated Hospital, Sun Yat-sen University

Country where clinical trial is conducted

China, 

References & Publications (2)

Camacho-Mauries D, Rodriguez-Díaz JL, Salgado-Nesme N, González QH, Vergara-Fernández O. Randomized clinical trial of intestinal ostomy takedown comparing pursestring wound closure vs conventional closure to eliminate the risk of wound infection. Dis Colon Rectum. 2013 Feb;56(2):205-11. doi: 10.1097/DCR.0b013e31827888f6. — View Citation

Lim JT, Shedda SM, Hayes IP. "Gunsight" skin incision and closure technique for stoma reversal. Dis Colon Rectum. 2010 Nov;53(11):1569-75. doi: 10.1007/DCR.0b013e3181f0535a. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Other Patient's satisfaction about the wound after stoma reversal 1 year
Primary superficial wound infection of stoma site 1 year
Secondary Healing time after stoma reversal 1 year
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