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
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Colostomy
• Surgical Wound

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

External Links

•   the Technique used in this trial