Clinical trial · Interventional
NPWT in Patients Undergoing Surgical Procedures for Management of GI Malignancies
Randomized Trial of Prolonged Use of Negative Pressure Wound Therapy in Patients Undergoing Surgical Procedures for the Management of Gastrointestinal Malignancies
NCT04955730CI-TRIAL-00114059completedPhase 2 / Phase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This randomized trial will use a Negative Pressure Wound Therapy device or standard wound closure, in participants with gastrointestinal neoplasms, to measure the rate of surgical site infections
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Surgical Wound Infection | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Negative Pressure Wound Therapy | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- NPWT - Negative Pressure Wound Therapy
- description
- Participants will receive Negative Pressure Wound Therapy (NPWT) after surgery and wear the NPWT until postop day 3. NPWT dressing will be removed and a new NPWT will be replaced until Postop day 7, where NPWT dressing will be removed.
- interventionNames
- Device: Negative Pressure Wound Therapy
- type
- NO_INTERVENTION
- label
- Standard of Care Wound Therapy
- description
- Participants will receive standard of care wound therapy after surgery. Postop day 3, dressings will be removed and new sterile dressings will be applied if needed.
Primary outcomes (3)
- measure
- Surgical Site Infection - Superficial Incisional
- timeFrame
- 30 days post operation
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Scheduled surgical procedure for the management of gastrointestinal cancer * Scheduled surgical procedure planned for incision that will result in wound \>5cm * Scheduled surgical procedure planned for skin wound that will be closed by primary intention with either: Staples covered by sterile Telfa® and Tegaderm® or Medipore® OR Dermal or subcuticular sutures covered by Octil® * Provision of signed and dated informed consent form * Stated willingness to comply with all study procedures and availability for the duration of the study Exclusion Criteria: * Scheduled surgical procedure where wound considered dirty * Scheduled surgical procedure for wound left for closure by secondary intention * Emergency surgery * Pregnancy. Pregnancy status is confirmed per protocol the day of surgery in the preoperative space by urine pregnancy test in patient younger than 65 and with intact uterus. Pregnant patient will be excluded from this study * History or current diagnosis of any medical or psychological condition that in the Investigator's opinion, might interfere with the subject's ability to participate in the study or the inability to obtain informed consent because of psychiatric or complicating medical problems
References
Publications (0)
Data not yet available
No reference posted for this study.