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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control group | Experimental | sinus pilonidal excision and standard cares |
|
| PRGF group | Experimental | sinus pilonidal excision+ PRGF |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sinus pilonidal excision+ PRGF | Procedure | open sinus pilonidal excision and plasma rich grow factor infiltration intra and postoperatively |
|
| Measure | Description | Time Frame |
|---|---|---|
| healing time(days) of pilonidal sinus wound excision | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| postoperative pain | using VAS to assess postoperative pain | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| postoperative bleeding | 1 week | |
| surgical site infection rate | 1 month | |
| sinus recurrence rate |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Juan Bellido Luque | Quirón Sagrado Corazón Hospital, Seville, Spain | Principal Investigator |
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| ID | Term |
|---|---|
| D010864 | Pilonidal Sinus |
| ID | Term |
|---|---|
| D003560 | Cysts |
| D009369 | Neoplasms |
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| sinus pilonidal excision and standard cares | Procedure | sinus pilonidal excision and postoperative standard care with povidone daily |
|
| 4 years |
| quality of life | this measure is assessed asking the possibility of standing in Water closet(WC) or walking correctly. | 6 months |