Clinical trial · Interventional
The Risk of Postoperative Wound Complications Following the Use of Negative Pressure Wound Therapy in Patients Undergoing Mastectomy
The Risk of Postoperative Wound Complications Following the Use of Avelle Negative Pressure Wound Therapy in Patients Undergoing Mastectomy and Flap fiXation: a Pilot Study
NCT03942575CI-TRIAL-00045774ALEXcompletedN/AClinicalTrials.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)
To evaluate the risk of postoperative wound complications following the use of Avelle negative pressure wound therapy in patients undergoing mastectomy and flap fixation, which might serve as a basis for a randomized controlled trial
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 |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Wound Complication | — | UNRESOLVED | — |
| Wound Dehiscence | — | UNRESOLVED | — |
| Wound Infection | — | UNRESOLVED | — |
| Wound Necrosis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Negative pressure wound therapy | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- No negative pressure wound therapy
- description
- Historical cohort: patients who underwent mastectomy with flap fixation using tissue glue and sutures and closed suction drainage and where negative wound pressure therapy has been omitted
- type
- EXPERIMENTAL
- label
- Negative pressure wound therapy
- description
- Prospective cohort: patients who underwent mastectomy with flap fixation using tissue glue and sutures and closed suction drainage with negative wound pressure therapy
- interventionNames
- Device: Negative pressure wound therapy
Primary outcomes (1)
- measure
- Number of patients with post-operative wound complications
- timeFrame
- During the first three postoperative months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Older than 18 years * Female sex * Indication for mastectomy or modified radical mastectomy Exclusion Criteria: * Patients undergoing breast conserving therapy * Patients undergoing direct breast reconstruction * Unable to comprehend implications and extent of study and sign for informed consent * Participation in other study
References
Publications (1)
- DERIVEDDe Rooij L, van Kuijk SMJ, van Haaren ERM, Janssen A, Vissers YLJ, Beets GL, van Bastelaar J. Negative pressure wound therapy does not decrease postoperative wound complications in patients undergoing mastectomy and flap fixation. Sci Rep. 2021 May 5;11(1):9620. doi: 10.1038/s41598-021-89036-3. PMID 33953312