NCT02246192

Brief Summary

The use of plasma rich in growth factors in wound excision pilonidal sinus could improve the healing process of the wound, when compared with the usual technique of daily local healing. The investigators propose the objective of evaluating the efficacy of intra- and postoperative application of plasma rich in growth factors, to reduce healing time and complications, arising from its removal, compared to the standard surgical treatment.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2008

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2008

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 13, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 22, 2014

Completed
Last Updated

March 19, 2015

Status Verified

March 1, 2015

Enrollment Period

5.2 years

First QC Date

August 13, 2014

Last Update Submit

March 18, 2015

Conditions

Pilonidal Sinus

Outcome Measures

Primary Outcomes (1)

  • healing time(days) of pilonidal sinus wound excision

    6 months

Secondary Outcomes (1)

  • postoperative pain

    1 month

Other Outcomes (4)

  • postoperative bleeding

    1 week

  • surgical site infection rate

    1 month

  • sinus recurrence rate

    4 years

  • +1 more other outcomes

Study Arms (2)

control group

EXPERIMENTAL

sinus pilonidal excision and standard cares

Procedure: sinus pilonidal excision and standard cares

PRGF group

EXPERIMENTAL

sinus pilonidal excision+ PRGF

Procedure: sinus pilonidal excision+ PRGF

Interventions

sinus pilonidal excision+ PRGFPROCEDURE

open sinus pilonidal excision and plasma rich grow factor infiltration intra and postoperatively

PRGF group
sinus pilonidal excision and standard caresPROCEDURE

sinus pilonidal excision and postoperative standard care with povidone daily

control group

Eligibility Criteria

Age13 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients among 13 and 65 years old
  • Possibility of observation during the follow-up period
  • Patients who have read and signed informed consent

You may not qualify if:

  • Abscessed pilonidal sinus
  • Recurrent pilonidal sinus
  • Patients treated with immunosuppressive drugs or anticoagulants

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pilonidal Sinus

Condition Hierarchy (Ancestors)

CystsNeoplasms

Study Officials

  • Juan Bellido Luque

    Quirón Sagrado Corazón Hospital, Seville, Spain

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ph.D

Study Record Dates

First Submitted

August 13, 2014

First Posted

September 22, 2014

Study Start

November 1, 2008

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

March 19, 2015

Record last verified: 2015-03