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THE EFFECT OF POSTOPERATIVE NEGATIVE PRESSURE WOUND THERAPY ON THE INCIDENCE WOUND DEHISCENCE IN LOW AND HIGH-RISK BREASTRECONSTRUCTION PATIENTS.


- candidate number26760
- NTR NumberNTR6647
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR24-feb-2017
- Secondary IDsABR-Number NL 60146.091.16 File Code: 2017-3179
- Public Title THE EFFECT OF POSTOPERATIVE NEGATIVE PRESSURE WOUND THERAPY ON THE INCIDENCE WOUND DEHISCENCE IN LOW AND HIGH-RISK BREASTRECONSTRUCTION PATIENTS.
- Scientific Title THE EFFECT OF POSTOPERATIVE NEGATIVE PRESSURE WOUND THERAPY ON THE INCIDENCE OF WOUND DEHISCENCE IN LOW AND HIGH-RISK PATIENTS UNDERGOING PLASTIC SURGERY.
- ACRONYMDEhiscence PREvention Study II
- hypothesisThe use of incisional management system reduces the incidence of wound dehiscence in low and high-risk patients undergoing plastic surgery.
- Healt Condition(s) or Problem(s) studiedWound healing, Wound dehiscence, Negative pressure therapy
- Inclusion criteriao > 18 years
o signed informed consent

Risk factors for wound dehiscence:
o Diabetes Mellitus (type 1 or type 2)
o BMI more than 30
o Smoking
o Radio therapy
o COPD
Undergoing one of those elective plastic surgeries:
o breast reconstruction with transabdominal incision (DIEP flap)
o pressure ulcers surgery (rotation flap) o VY- plastic o TFL-flap tensor fascia lata)
- Exclusion criteriafistula in incision area
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-nov-2017
- planned closingdate1-mrt-2019
- Target number of participants80
- InterventionsIn the experimental group Prevena™ Incision Management System is applicated in clean closed surgical incision.

In the controlgroup stery strips and foam are applicated in clean closed surgical incisions.
- Primary outcomepresence of wound dehiscence
presence of wound infection
- Secondary outcomepain
elasticity of the skin (skin tension)
- Timepoints- T-1 = Baseline
- T0 = day of surgery
- T1- T3 = day 1, 3, 5 post OK
- T4 = 2 weeks after surgery (1 month)
- T5 = 12 weeks after surgery (3 months)
- Tinc = T-incident
- Trial web sitewww.toetsingonline.nl
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMSc Emmy Muller-Sloof
- CONTACT for SCIENTIFIC QUERIESMSc Emmy Muller-Sloof
- Sponsor/Initiator Radboud University Medical Center - Department of Plastic and Reconstructive Surgery
- Funding
(Source(s) of Monetary or Material Support)
GD Medical Pharma BV
- Publications
- Brief summaryThis study is a follow-up to research DEPRES I (51649 (ABR-nummer) NL51649.091.14, NTR 5808 (2014-1443)

Wound dehiscence is a serious postoperative complication with high morbidity and high mortality and contributes to delays in the recovery process, repeat operations, prolonged hospital stays, high care costs and reduced ability to self-care. Despite developments in preventing wound infection (one of the predictors for wound dehiscence), the incidence of wound dehiscence has not been reduced in the last few decades. This may be attributable to increasing incidences of risk factors in patients. One of the precautionary actions in wound dehiscence is the use of postoperative negative pressure wound therapy (NPWT). The results of an incision management system using negative pressure therapy in preventing wound dehiscence are positive.

The aim of this study is to answer the question whether postoperative treatment with a wound dressing with negative pressure wound therapy decreases the incidence of wound dehiscence in patients who are at risk of wound dehiscence and who are undergoing an elective plastic surgery.
- Main changes (audit trail)
- RECORD24-feb-2017 - 11-mrt-2018


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