Clinical trial · Interventional
The Effect of Wound Problems Wound Dressing in Patients With Colorectal Cancer Surgery
The Effect of Surgical Wound Complications Profilactic Negative Pressure Wound Therapy in Patients With High Risk Colorectal Cancer Surgery
- 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 study was conducted as a randomized controlled trial in order to determine the effect of prophylactic negative pressure wound therapy for the prevention of surgical site complications in high-risk colorectal cancer surgery. Hypothesis: Prophylactic negative pressure wound therapy applied after open colorectal cancer surgery to high-risk patients affects surgical wound complications. pNBYT group: The study was completed with a total of 50 patients, 24 of intervention group anda 26 of the control group, who met the inclusion criteria at the surgical oncology service of a university hospital. The data were collected using Patient Identification Form, Surgical Procedure Form, Wound Follow-up Chart and ASEPSİS Wound Scoring System. Ethics committee approval and written informed consent of the individuals was taken in the research. The data were analyzed in SPSS Statistics 24.0 program using Shapiro Wilk test and Q-Q graphs, Independent Sample t test, Mann Whitney U test, Chi-square, Cochran's Q and Friedman test. The value of p\<0.05 was accepted for the statistical significance level. It was determined that the groups were similar in terms of identification and surgical procedure characteristics.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Surgery | — | UNRESOLVED | — |
| Surgery--Complications | — | UNRESOLVED | — |
| Surgical Site Infection | — | UNRESOLVED | — |
| Wound Complication | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| pNBYT | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- intervention grpup
- description
- pNPWT device was placed in the pNPWT group for seven days. The incision area was evaluated during the first seven days, and on the 15th, 21st, and 30th days postoperatively for the presence of hematoma, seroma, wound dehiscence/evisceration, and SSI.
- interventionNames
- Device: pNBYT
- type
- NO_INTERVENTION
- label
- control group
- description
- The wound of the control group was covered with a sterile gauze dressing. After the wound was left closed for 48 hours in the clinical routine, the surgical site was left open, supporting healing. Therefore, the dressing of the control group was removed after 48 hours, and the wound was left open. The incision area was evaluated during the first seven days, and on the 15th, 21st, and 30th days postoperatively for the presence of hematoma, seroma, wound dehiscence/evisceration, and SSI.
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: Patients undergoing open colorectal cancer surgery, clean-contaminated (Class-II) or contaminated (Class-III) wounds, ASA 2, 3, or 4, and fulfilling at least one of the following criteria were included: * 75 years old and above, * Chronic disease such as Diabetes (DM), Chronic obstructive pulmonary disease (COPD), Heart failure (Ejection fraction ≤ 40%), Preoperative anemia (Hb≤10mg/dl), * Nutritional problems (BMI 30 kg / m2 and over, malnutrition (NRS 2002 score 3 and over or albumin≤3 mg/dl), * Regular steroids or anticoagulants, * Neoadjuvant chemotherapy and radiotherapy. Exclusion Criteria: \-
References
Publications (1)
- DERIVEDKacmaz HY, Baser M, Sozuer EM. Effect of Prophylactic Negative-Pressure Wound Therapy for High-Risk Wounds in Colorectal Cancer Surgery: A Randomized Controlled Trial. Adv Skin Wound Care. 2022 Nov 1;35(11):597-603. doi: 10.1097/01.ASW.0000874168.60793.10. PMID 36264751