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

Hospital Quiron Sagrado Corazon

Status: Completed

Conditions: Pilonidal Sinus

Treatments: Procedure: sinus pilonidal excision+ PRGF; Procedure: sinus pilonidal excision and standard cares

Study type: Interventional

Funder types: Other

Identifiers

NCT02246192

Sinusprgf

Details and patient eligibility

About

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.

Full 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.

Enrollment: 51 patients

Sex: All

Ages: 13 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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51 participants in 2 patient groups

control group

Experimental group

Description:

sinus pilonidal excision and standard cares

Treatment:

Procedure: sinus pilonidal excision and standard cares

PRGF group

Experimental group

Description:

sinus pilonidal excision+ PRGF

Treatment:

Procedure: sinus pilonidal excision+ PRGF