Pilonidal SinusNCT02246192
Use of Plasma Rich in Growth Factors (PRGF) in Pilonidal Sinus Excision
A study testing sinus pilonidal excision+ PRGF in people with Pilonidal Sinus, run by Hospital Quiron Sagrado Corazon.
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. Read more about this study
- Who is it for?
- Ages 13 to 65 years
- Conditions the study is for
- Pilonidal Sinus
- What is being tested?
- sinus pilonidal excision+ PRGF
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- No sites listed yet
- Study dates
- Nov 2008to Jan 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients among 13 and 65 years old
- Possibility of observation during the follow-up period
- Patients who have read and signed informed consent
Who cannot join
- Abscessed pilonidal sinus
- Recurrent pilonidal sinus
- Patients treated with immunosuppressive drugs or anticoagulants
About this study
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.
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.
Read the 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
- Being tested
- sinus pilonidal excision+ PRGF, sinus pilonidal excision and standard cares
- Medical subject headings
- Pilonidal Sinus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sinus pilonidal excision+ PRGFProcedure or surgery
open sinus pilonidal excision and plasma rich grow factor infiltration intra and postoperatively
sinus pilonidal excision and standard caresProcedure or surgery
sinus pilonidal excision and postoperative standard care with povidone daily
| Study group | Role | What they receive |
|---|---|---|
| control group | Experimental | sinus pilonidal excision and standard cares Receives: Procedure: sinus pilonidal excision and standard cares |
| PRGF group | Experimental | sinus pilonidal excision+ PRGF Receives: Procedure: sinus pilonidal excision+ PRGF |
What is being measured
The primary outcome is the main question the study is designed to answer.
healing time(days) of pilonidal sinus wound excision
Measured: 6 months
Secondary outcomes (1)
postoperative pain
using VAS to assess postoperative pain
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2014 (estimated)
- Study startNov 2008
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pilonidal SinusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Quiron Sagrado Corazon
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juan Bellido Luque.MD, Hospital Quiron Sagrado Corazon
- Investigators
- Juan Bellido Luque, Principal investigator, Quirón Sagrado Corazón Hospital, Seville, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02246192
- Sponsor's protocol ID
- Sinusprgf
- Status last verified
- Mar 2015
- First submitted
- 13 Aug 2014
- Last updated
- 19 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02246192
- Acronym / sponsor ID
- Sinusprgf
- Conditions
- Pilonidal Sinus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Hospital Quiron Sagrado CorazonUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 22 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Experimental | Procedure: sinus pilonidal excision and standard caressinus pilonidal excision and standard cares |
| PRGF group | Experimental | Procedure: sinus pilonidal excision+ PRGFsinus pilonidal excision+ PRGF |
Who may qualify
- Ages
- 13 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients among 13 and 65 years old
- Possibility of observation during the follow-up period
- Patients who have read and signed informed consent
Key exclusion criteria (3 listed)
- Abscessed pilonidal sinus
- Recurrent pilonidal sinus
- Patients treated with immunosuppressive drugs or anticoagulants
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sinus pilonidal excision+ PRGFopen sinus pilonidal excision and plasma rich grow factor infiltration intra and postoperatively | Procedure or surgery | PRGF group |
| sinus pilonidal excision and standard caressinus pilonidal excision and postoperative standard care with povidone daily | Procedure or surgery | control group |
Primary outcome
healing time(days) of pilonidal sinus wound excision
Time frame: 6 months
1 secondary outcome
postoperative pain
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juan Bellido Luque principal investigator
Quirón Sagrado Corazón Hospital, Seville, Spain
Questions about this trial
What is this clinical trial studying?
A study testing sinus pilonidal excision+ PRGF in people with Pilonidal Sinus, run by Hospital Quiron Sagrado Corazon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
healing time(days) of pilonidal sinus wound excision (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2015.