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

Pilonidal Sinus Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02246192
• Other study ID #: Sinusprgf
• Status: Completed
• Phase: N/A
• First received: August 13, 2014
• Last updated: March 18, 2015
• Start date: November 2008
• Est. completion date: January 2014

Study information

• Verified date: March 2015
• Source: Hospital Quiron Sagrado Corazon
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Pilonidal Sinus

Intervention

Procedure:
• sinus pilonidal excision+ PRGF
open sinus pilonidal excision and plasma rich grow factor infiltration intra and postoperatively
• sinus pilonidal excision and standard cares
sinus pilonidal excision and postoperative standard care with povidone daily

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Quiron Sagrado Corazon

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	postoperative bleeding		1 week	Yes
Other	surgical site infection rate		1 month	Yes
Other	sinus recurrence rate		4 years	No
Other	quality of life	this measure is assessed asking the possibility of standing in Water closet(WC) or walking correctly.	6 months	No
Primary	healing time(days) of pilonidal sinus wound excision		6 months	No
Secondary	postoperative pain	using VAS to assess postoperative pain	1 month	No