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Use of Plasma Rich in Growth Factors (PRGF) in Pilonidal Sinus Excision

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ClinicalTrials.gov Identifier: NCT02246192
Recruitment Status : Completed
First Posted : September 22, 2014
Last Update Posted : March 19, 2015
Sponsor:
Information provided by (Responsible Party):
Juan Bellido Luque.MD, Hospital Quiron Sagrado Corazon

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.

Condition or disease Intervention/treatment Phase
Pilonidal Sinus Procedure: sinus pilonidal excision+ PRGF Procedure: sinus pilonidal excision and standard cares Not Applicable

Detailed Description:

prospective randomized control trial, comparing PRGF application vs daily local care(betadine +saline) in sinus pilonidal wound excision. PRGF is extracted from de patient blood and infiltrated in the pilonidal wound every week. this treatment is compared with betadine and saline wound care in terms of wound healing time, pospoperative pain and other complications.

this study try to keeps the advantages of using open technique for pilonidal desease( low recurrence rate and surgical site infections) and improving the disadvantages (high wound healing time and postperative pain with wore quality of life) when it´s compared with direct closure or flap techniques.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Supportive Care
Official Title: Application of PRGF (Plasma Rich in Growth Factors) to Reduce the Healing Time After Pilonidal Sinus Excision. A Randomized 5-years Prospective Controlled Trial.
Study Start Date : November 2008
Actual Primary Completion Date : January 2014
Actual Study Completion Date : January 2014

Arm Intervention/treatment
Experimental: control group
sinus pilonidal excision and standard cares
Procedure: sinus pilonidal excision and standard cares
sinus pilonidal excision and postoperative standard care with povidone daily

Experimental: PRGF group
sinus pilonidal excision+ PRGF
Procedure: sinus pilonidal excision+ PRGF
open sinus pilonidal excision and plasma rich grow factor infiltration intra and postoperatively




Primary Outcome Measures :
  1. healing time(days) of pilonidal sinus wound excision [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. postoperative pain [ Time Frame: 1 month ]
    using VAS to assess postoperative pain


Other Outcome Measures:
  1. postoperative bleeding [ Time Frame: 1 week ]
  2. surgical site infection rate [ Time Frame: 1 month ]
  3. sinus recurrence rate [ Time Frame: 4 years ]
  4. quality of life [ Time Frame: 6 months ]
    this measure is assessed asking the possibility of standing in Water closet(WC) or walking correctly.



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Ages Eligible for Study:   13 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02246192


Sponsors and Collaborators
Hospital Quiron Sagrado Corazon
Investigators
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Principal Investigator: Juan Bellido Luque Quirón Sagrado Corazón Hospital, Seville, Spain

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Responsible Party: Juan Bellido Luque.MD, Ph.D, Hospital Quiron Sagrado Corazon
ClinicalTrials.gov Identifier: NCT02246192     History of Changes
Other Study ID Numbers: Sinusprgf
First Posted: September 22, 2014    Key Record Dates
Last Update Posted: March 19, 2015
Last Verified: March 2015
Additional relevant MeSH terms:
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Pilonidal Sinus
Cysts
Neoplasms
Mitogens
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action