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

Not Applicable

Completed

• Conditions: Pilonidal Sinus
• Interventions: Procedure: sinus pilonidal excision+ PRGF; Procedure: sinus pilonidal excision and standard cares

• Registration Number: NCT02246192
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2008-11
• Primary Completion: 2014-01
• Study Completion: 2014-01
• Study First Submitted: 2014-08-13
• Study First Submitted QC: 2014-09-19
• Study First Posted: 2014-09-22
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-18
• Last Update Posted: 2015-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PRGF group	sinus pilonidal excision+ PRGF	sinus pilonidal excision+ PRGF
control group	sinus pilonidal excision and standard cares	sinus pilonidal excision and standard cares

Primary Outcome Measures

Name	Time	Method
healing time(days) of pilonidal sinus wound excision	6 months

Secondary Outcome Measures

Name	Time	Method
postoperative pain	1 month	using VAS to assess postoperative pain