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NCT03111134
A New Abdomen Closure Technology Based on Component Separation: a Prospective Randomized Controlled Trial
NA trial testing modified component separation technique in Fascial Closure in 220 participants. Status unknown.
31 October 2018
Quick facts
| Lead sponsor | Xijing Hospital of Digestive Diseases |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 220 |
| Start date | 1 May 2017 |
| Primary completion | 31 October 2018 |
| Estimated completion | 31 December 2018 |
| Sites | 1 location across China |
Drugs / interventions tested
- modified component separation technique
Conditions studied
- Fascial Closure — all drugs for Fascial Closure →
Sponsor
Xijing Hospital of Digestive Diseases
Who can join
18 and older, any sex, with Fascial Closure. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
At present, open-type abdominal surgery is routine access into the abdomen. Median incision is the common choice with open-type abdominal surgery. Layered abdomen-closing is often used at the end-time of the surgery. There are some common postoperative complications, such as incision pain, surgical site infection, surgical incision dehiscence and incisional hernia. The key to reduce the incidence of postoperative complications depends on safe and reliable technology of abdomen-closing. It's usually difficult to close the abdomen after the incisional hernia surgery, and the recurrence of incisional hernia is high. But the recurrence fell off observably when component separation technology was applied to abdomen-closing of incisional hernia. Based on this, we hypothesis that modified-CST applied to abdomen-closing in routine abdominal surgery may improve the quality of wound-healing. In this prospective single-blind randomized controlled trial, traditional abdomen-closing technology and modified-CST will be used to gastric cancer surgery, and the quality of wound-healing will be evaluated to confirm which kind of abdomen-closing technology better.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03111134 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Xijing Hospital of Digestive Diseases
- Last refreshed: 12 April 2017
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03111134.
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