Clinical trial · Interventional
Closed Incision Disposable Negative Pressure Wound Therapy in Immediate Postmastectomy Breast Reconstruction
Experience and Comparison Between Closed Incision Disposable Negative Pressure Wound Therapy With Standard Care in Immediate Postmastectomy Breast Reconstruction - Prospective, Randomized and Controlled Study
- 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)
The study aimed to assess the impact of the use of closed incision negative pressure wound therapy (ciNPWT) after immediate breast reconstruction on the number of surgical-site complications, skin surface temperature, objective elastic and viscoelastic and subjective scar's quality to determine risk factors that could be considered as indications for prophylactic ciNPWT application.
Conditions
Conditions (2)
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 |
| Breast Reconstruction | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Immediate Breast reconstruction | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- VAC group
- description
- A randomized group of patients receiving negative pressure wound therapy dressing (Avelle-ConvaTec) on closed incision
- interventionNames
- Procedure: Immediate Breast reconstruction
- type
- ACTIVE_COMPARATOR
- label
- ST group
- description
- A randomized group of patients receiving standard dressing (sterile gauze and medical tape) on closed incision
- interventionNames
- Procedure: Immediate Breast reconstruction
Primary outcomes (2)
- measure
- Postsurgical complications - reported for 60 patients
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * \>= 18 years of age * indications for immediate breast reconstruction Exclusion Criteria: * pregnancy or lactation, * use of steroids, use of immune modulators known to affect wound healing; * tattoos in the area of the incision; * breast skin conditions such as cutis laxa;
References
Publications (4)
- RESULTSingh D, Lobach V, Holton T. Use of Closed-Incision Negative-Pressure Therapy in Aesthetic Surgery. Plast Reconstr Surg. 2019 Jan;143(1S Management of Surgical Incisions Utilizing Closed-Incision Negative-Pressure Therapy):11S-14S. doi: 10.1097/PRS.0000000000005306. PMID 30586097
- RESULTWilly C, Agarwal A, Andersen CA, Santis G, Gabriel A, Grauhan O, Guerra OM, Lipsky BA, Malas MB, Mathiesen LL, Singh DP, Reddy VS. Closed incision negative pressure therapy: international multidisciplinary consensus recommendations. Int Wound J. 2017 Apr;14(2):385-398. doi: 10.1111/iwj.12612. Epub 2016 May 12. PMID 27170231
- RESULTGabriel A, Sigalove SR, Maxwell GP. Initial Experience Using Closed Incision Negative Pressure Therapy after Immediate Postmastectomy Breast Reconstruction. Plast Reconstr Surg Glob Open. 2016 Jul 22;4(7):e819. doi: 10.1097/GOX.0000000000000803. eCollection 2016 Jul. PMID 27536498
- RESULTGabriel A, Sigalove S, Sigalove N, Storm-Dickerson T, Rice J, Maxwell P, Griffin L. The Impact of Closed Incision Negative Pressure Therapy on Postoperative Breast Reconstruction Outcomes. Plast Reconstr Surg Glob Open. 2018 Aug 7;6(8):e1880. doi: 10.1097/GOX.0000000000001880. eCollection 2018 Aug. PMID 30324063