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

NCT ID: NCT02246192

Last Updated: 2015-03-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-11-30
• Study Completion Date: 2014-01-31

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.

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.

Conditions

Pilonidal Sinus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

control group

sinus pilonidal excision and standard cares

Group Type: EXPERIMENTAL

sinus pilonidal excision and standard cares

Intervention Type: PROCEDURE

sinus pilonidal excision and postoperative standard care with povidone daily

PRGF group

sinus pilonidal excision+ PRGF

Group Type: EXPERIMENTAL

sinus pilonidal excision+ PRGF

Intervention Type: PROCEDURE

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

Interventions

sinus pilonidal excision+ PRGF

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

Intervention Type: PROCEDURE

sinus pilonidal excision and standard cares

sinus pilonidal excision and postoperative standard care with povidone daily

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Quiron Sagrado Corazon

OTHER

Sponsor Role: lead

Responsible Party

Juan Bellido Luque.MD

Ph.D

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Juan Bellido Luque

Role: PRINCIPAL_INVESTIGATOR

Quirón Sagrado Corazón Hospital, Seville, Spain

Other Identifiers

Sinusprgf

Identifier Type: -

Identifier Source: org_study_id