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Subcutaneous Closed-Suction Drainage Affects Surgical Wounds Healing in Lower Gastrointestinal Open Surgery: a Randomized Controlled Study

Subcutaneous Closed-Suction Drainage Affects Surgical Wounds Healing in Lower Gastrointestinal Open Surgery: a Randomized Controlled Study

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05318430
Enrollment
228
Registered
2022-04-08
Start date
2021-02-01
Completion date
2022-12-31
Last updated
2022-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

All Diseases That Require Gastrointestinal Open Surgery

Brief summary

This is a single-center, randomized controlled trial to evaluate whether subcutaneous closed-suction drainage would decrease the incidence of poor surgical site healing in lower gastrointestinal open surgery. The independent risk factors of the incidence of poor surgical wounds healing in lower gastrointestinal open surgery will be analyzed.

Interventions

DEVICESubcutaneous closed-suction drainage device

This subcutaneous closed-suction drainage device was designed to be placed subcutaneously when surgeons have completed all intra-abdominal operations and are about to suture subcutaneous layer and skin

Sponsors

Beijing Friendship Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

Inclusion criteria

* aged 18-85 years old, male or female * all patients underwent lower gastrointestinal surgery: the digestive tract below Treitz ligament was called lower gastrointestinal tract, including jejunum, ileum, ileocecal part and colorectal * open surgery (instead of laparoscopic) required * willing participated in clinical verification and signed informed consent.

Exclusion criteria

* laparoscopic surgery * upper gastrointestinal surgery (esophagus, stomach, duodenum and hepatobiliary pancreas) * simple appendectomy / total appendectomy * hernia surgery and intestinal obstruction surgery without intestinal resection * infection of incision site before operation * pregnant women * expected death within 1 month after operation.

Design outcomes

Primary

MeasureTime frame
Rate of poor healing of incisionsWithin 30 days after surgery

Countries

China

Contacts

Primary ContactJun Li, M.D.
lijunsy2002@ccmu.edu.cn+86 13811379656

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026