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post operative negatieve pressure therapy after pilonidal sinus excision.

post operative negatieve pressure therapy after pilonidal sinus excision. - the SiPiVAC trial: the Sinus Pilinodalis Vacuum trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON33917
Enrollment
132
Registered
2009-07-28
Start date
2009-09-01
Completion date
Unknown
Last updated
2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

pilonidal sinus the jeep's disease

Interventions

vacuum wound therapy for 2 weeks.

Sponsors

Sint Franciscus Gasthuis
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Inclusion Criteria ;- 18 years or older, mentaly capable of making decision - symptomatic sinus pilonidalis - intention to undergo surgery - written informed consent

Exclusion criteria

Exclusion criteria: Exclusion Criteria;- severe language problem (dutch) - abces sinus pilonidalis - recurrent sinus pilonidalis after former excision - too little space to insert the vacuumsponge (

Design outcomes

Primary

MeasureTime frame
Primary parameters: - short term parameter: wound size (length, broadth, depth) after 14 days compared with day t=0 (surgery date) - long term paramater: number of days to total wound healing Definitions: - total wound healing is wound depth of 0 mm

Secondary

MeasureTime frame
Secundary parameters: - cumulatief recurrancepercentage after 6 maanden - amount off days till full function of the patient after surgery - painscore (VAS) - woundcomplications: infection, abces of bleeding - (technical) problems with the VAC-system - percentage of patiënts stopping with VAC-therapie before 14 days Definities - Infection is defined as a bacterial infection causing antibiotics use. - An abces of bleeding is scored if surgical intervention is necessary.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)